Document 5YNO19kn4Ybx8ZX4NyXdy6XN

PROCEDURE BULLETIN--tfxas city INSPECTION OF MANUFACTURING FACILITIES BY THE POOD AND DRUG ADMINISTRATION .ANT P-97 I. PURPOSE The Food and Drug Administration (FDA) of the United States Department of Health, Education, and Welfare has, among its other duties, the responsibility for inspecting factories, warehouses, etc., where products covered by the Federal Food, Drug, and Cosmetic Act are produced and stored. The purpose of such inspections is to determine the establishment's com pliance with the law and to gather evidence for use in en forcement proceedings if violations are found. The purpose of this Manual is to outline the Company's policy and proce dures to be followed when a Food and Drug Administration Inspector asks to inspect facilities or products of Monsanto. II. POLICY The Company agrees with the spirit and intent of the Food and Drug Administration in desiring to insure that foods, drugs, and cosmetics are safe,for use. It obeys the law and willingly cooperates with the FDA in the administration of the Food, Drug, and Cosmetic Act. Thus, it is the policy of the Company to disclose all information within the scope of the FDA's inspec tion authority and which is requested by an FDA Inspector. It is further the policy of the Company to treat the Inspec tors courteously and in a friendly manner. Nevertheless, with our competitive commercial position also in mind, it is the policy of the Company to decline politely but firmly to permit inspection of products or facilities not covered by the Act and to decline to provide any confidential process or commercial data (even on inspectable products) beyond the re quirements of the Act, and to explain our grounds for doing so. Ill. SCOPE FDA inspectors are authorized to inspect facilities for pro ducts which are used in foods or may come into contact with foods. At Texas City, this inspection authority is limited to the process units, the warehouses or storage tanks and the shipping containers for polyethylene and lactic acid. The Inspector will not be permitted to inspect facilities for any product other than those designated, nor will they be given any confidential process or cost information. Laboratory facilities are not inspectable. sc 005001 LAM006212 ORIGINAL ISSUE: 1-10-64 REVISED: 12/21/78 PAGE -L_0Fil. PROCEDURE BULLETIN--texas city plant p^q9Q7 INSPECTION OF MANUFACTURING FACILITIES BY THE FOOD AND DRUG ADMINISTRATION IV. RESPONSIBILITIES A. The Law Department shall be responsible for interpreting and ruling on legal matters where appropriate and shall assist in coordinating compliance with the Act. B. The Divisional Representative shall be responsible for coordinating that Division's FDA activities. Each divi sion may also designate an Alternate Representative to act in the unavoidable absence of the Division Representa tive . The Division Representative will review with the Plant Representative any matters which the Inspector has not been able to resolve at the plant and which have been summarized in writing from the Plant Representative to the Division Representative. If such matters cannot be resolved adequately at this point, the Division Repre sentative will provide appropriate technological and commercial viewpoints and background information to the Company Representative in his review with the FDA. C. The Medical Department will advise Divisional Representa tives on any medical or toxicological question arising in connection with the factory inspection. D. The 'Washington Office will keep abreast of existing and new FDA regulations as they bear on factory inspection. It will advise the Law Department, Company and Medical Representatives as relevant matters arise. E. An FDA Inspection Coordination Committee, consisting of a Law Department Representative, all Division Representa tives, a Medical Department Representative, and a Washington Office Representative, shall meet annually or as required to review the conduct and results of inspections and to consider procedures, legislation, and other pertinent mat ters. F. A Plant Representative shall be designated at each plant in the Company producing products subject to FDA inspec tion. Where a plant has activities of more than one business group, this designation will be the responsi bility of the host business group. The Plant Representa tive shall be responsible for carrying out the procedure at his plant, including personal guidance of all FDA In spectors while they are in the plant. sc 005002 LAM006213 ORIGINAL ISSUE: i-io-64 REVISED: 12-21-78 PAGE _2_ OFii PROCEDURE BULLETIN--Texas city plant P-0907 INSPECTION OF MANUFACTURING FACILITIES BY THE FOOD AND DRUG ADMINISTRATION_______________________________________________ Several important qualifications are necessary for the Plant Representative: He must be an individual who can explain the Company's position in a courteous and friendly manner and indicate to the Inspector that Monsanto wishes to conform to the full letter and spirit of the law. Second, he must be able, firmly but courteously, to decline to disclose any information that is not authorized by this Manual. Third, he must have a broad knowledge of the products produced at his plant. In particular, he should have a detailed knowledge of inspectable products and know the relation of the products to the end-use applications, conditions of use, "downstream" fabrication or processing, ultimate distribution, etc., especially as they relate to food, drugs, and cosmetics. Finally, his duties should be such as to permit ready availability to an FDA Inspector should he call. There shall be designated individuals to supplement the informa tion of the Plant Representative - the Manufacturing Superintendent(s), the Chief Chemist, and the Plant Services Superintendent. If the designated Plant Representative is not able to answer a proper question, he will take the Inspector to the appropriate individual of the above group for the answer and will remain with them. The Plant Representative will guide the conversation so that the In spector's questions are answered clearly and concisely. To provide coverage for guest Business Groups in the plant, the appropriate Guest Superintendent will normally represent his group. The plant will designate an Alternate Plant Representative to super vise plant inspections in the absence of the Plant Itepresentative. His qualifications are the same as those of the Plant Representative. He will be selected from one of the individuals designated in the two previous paragraphs. The Plant Representative has the prime responsibility of dealing with the FDA Inspector. Only in the case of his unavoidable absence can the FDA Inspector be hosted by the Alternate Plant Representa tive. The Plant Representative shall accompany the Inspector at all times while he is in the plant. SC 005003 ORIGINAL ISSUE: i-iq-64 T REVISED: 12-21-78 LAM00S214 PAGE -LOFii PROCEDURE BULLETiN --texas city plant p-0907 INSPECTION OF MANUFACTURING FACILITIES BY THE FOOD AND DRUG ADMINISTRATION Foremen, operators, laboratory analysts, etc., will be instructed not to volunteer information or to answer questions of the FDA Inspector. They will refer the Inspector to the Plant Representative for answer. Each plant will be supplied by the Division Representative with a list of its products judged by the Company to be properly inspectable by the FDA. The Plant Representative will only permit inspection of those products on this list. Should the Inspector differ with the Plant Representative on the decision on any individual product, the Plant Repre sentative will courteously explain the basis of the decision. Should the Inspector still not be satisfied, the Plant Repre sentative will suggest that the Inspector submit his questions in writing for review by the Daw Department If requested by the FDA Inspector, the Plant Representative will enumerate orally the products of his plant which Monsanto considers inspectable. However, this procedure in its entirety is confidential and is not to be shown to the Inspector; i.e. , the procedure itself is not inspectable. V. PROCEDURE . A. Arrival of Inspector The Plant Receptionist and the Plant Guard shall have been informed of the identity of the Plant Representative and Alternate. Upon arrival of an FDA Inspector, the Recep tionist shall immediately contact the Plant Representative announcing the Inspector. The law provides that the in spection may be carried out at any reasonable time. This is construed to mean any time during regular plant office hours (8:00 A. M. to 4:30 P. M. , or whatever other hours are normal for the location, on Monday through Friday, except for official plant holidays). Should the Inspector call at hours other than the above, the Plant Guard shall invite the Inspector to come back on the next regular work day. The Guard will promptly inform the Plant Representative at his home. As soon as the Plant Representative learns of the presence of an FDA Inspector in the plant, he will immediately notify the Plant Manager. Sc 005004 LAM006215 ORIGINAL ISSUE: i-i-64 REVISED: 12-21-78 PAGE i_0F_L! PROCEDURE BULLETIN --TEXAS CITY INSPECTION OF MANUFACTURING FACILITIES BY THE FOOD AND DRUG RDMTNTSTRATTON 0907 B. Plant Representative's initial Contact In the interest of good relations with the Inspector, the Plant Representative will make himself immediately avail able to the Inspector and proceed to the reception area to meet him. The FDA inspection will take precedence over any other demand on the Plant Representative's attention except serious emergencies. In no event shall the Inspector be kept waiting longer than 15-20 minutes. C. Plant Manager's Reception of inspector The Plant Representative will escort the Inspector to the Plant Manager's office. The Plant Manager, as chief execu tive officer, shall be the first plant person to interview the Inspector. The FDA is interested in meeting the Plant Manager as the "Responsible Party" for conditions in his plant. In addition to welcoming the Inspector, the Plant Manager will inquire as to the purpose of the inspection Ce.g., routine inspection or suspicion of violation in re sponse to complaint). He will also advise the Inspector that the Plant is not engaged in the manufacture of pre scription drugs and that the only drugs the company pro^ duces are bulk pharmaceuticals. The Plant Manager will confirm to the Inspector the authority of the Plant Rep resentative in guiding him and assisting in the inspec tion. The Plant Representative will, of course, be pres ent during this interview. D. Inspection Notice The Plant Manager or Plant Representative shall request credentials of the Inspector, make note of the Inspector's number and name, and require a properly executed Notice of inspection (Form FD 432) addressed* to' the- Plant Manager and signed by the Inspector. Under all circumstances these papers must be reviewed and accepted by the Plant Manager or Plant Representative before any inspection is begun. E. Notification of Division Representative As soon as possible, the Plant Representative shall notify the Division Representative by telephone or teletype of the arrival of the Inspector, together with any appropriate details. SC 005005 LAM006216 ORIGINAL ISSUE.* 1-10-64 REVISED: 12-21-78 PAGE_5_0Fii PROCEDURE BULLETIN--TEXAS CITY PLANT Pvogn? INSPECTION OF MANUFACTURING FACILITIES BY THE FOOD AND DRUG ADMINISTRATION F. Information Covered by the Act The inspection authority of the FDA under the Act extends primarily to visual inspection of locations where food, drugs, and cosmetics are made or stored. Legally, Monsanto's obligation during such inspections (except for an inspec tion of a prescription drug plant) is limited to permitting entry and inspection "at reasonable times within reasonable limits and in a reasonable manner of any factory, warehouse, establishment, or vehicle and all pertinent equipment...' in which food, drugs, devices or cosmetics are manufactured, processed, packed, held or transported in, or for introduc tion into interstate commerce, as well as inspection of any*... finished and unfinished materials, containers, and labeling therein." The FDA considers that food additives come within the definition of "food" in the Act since they are deemed to by "components of food". Consequently, plants where these products are manufactured or held are also subject to in spection by the FDA. It should be noted that the FDA instructs its inspectors to ask permission, during an inspection, to see more informa tion and material than the factory is legally required to show him. For example, the Inspectors are instructed to ask for such items as formulas, complaint files, and other records which the FDA has admitted are not subject to inspection under present law relating to general establishment inspections. However, if such documents and records are given to the In spector voluntarily by the plant, they may be used by the FDA in proceedings against the Company for violation of the Act. It is important, therefore, that any inspection be restricted to only Inspectable items and areas. Following are categories of items which we are required to disclose during a general establishment inspection by the FDA. 1. Specifications Only those specifications that are public knowledge shall be released to the Inspector. These are the specifications such as those published in Company Sales Brochures, Technical Data Sheets and Product Profile Sheets, or in any of the official compedia (i.e., the official United States Pharmacopoeia, or the Food Chemicals Codex). No other specifications will be given to the Inspector. LAM006217 ORIGINAL ISSUE 1-10-64 REVISED: 12-21-78 PAGE._0FiL PROCEDURE BULLETIN--texas city plant ?^q907 INSPECTION OF MANUFACTURING FACILITIES BY THE FOOD AND DRUG ADMINISTRATION The Plant Representative should have on hand the specifications that can be disclosed for each inspectable product. However, the law does not re quire that the Inspector be permitted to examine analytical data on properties included in specifi cations, nor does it require disclosure of test methods relating to specifications. Only those test methods published in the official, compendia may be given to the Inspector. 2. Samples If the Inspector requests a sample of any finished or unfinished goods given on the plant list of FDA inspectables, it will be provided him. In all cases, the Plant Representative will take a sample identical to the one provided to the Inspector and will label his sample in full detail. The rep resentative will offer to furnish sample bottles, both for the Inspector and for the plant files,unless the Inspector prefers to use his own sample containers. The Inspector must furnish a Receipt for Sample (Form FD-484) fully describing each sample that he takes -- date, place, method of sampling, person sampling. The Plant Representative will arrange for prompt and careful analysis of his own sample. The FDA is re quired to inform the Company of the results of the analysis of its sample. Upon receipt of this informa tion, the Plant Representative will compare it with the results obtained by his own laboratory on his sample and submit the data as a supplement to his Inspection Report (Section V-J of this Manual). Reso lutions of differences, if any, will be taken up with the Division Representative. 3. Visual Inspection of Plant Production Facilities The Inspector is legally permitted to inspect visually all relevant areas of the manufacturing and warehousing facilities for inspectable products that are relevant to purposes of Act plus "all pertinent equipment, fin ished materials, containers, and labelling" pertaining to such inspectable products. SC 005007 ORIGINAL ISSUE: 1-10-64 REVISED: 12-21-78 LAM006218 PAGE JLOFiLL PROCEDURE BULLETIN--texas city plant P-0907 INSPECTION OF MANUFACTURING FACILITIES BY THE FOOD AND DRUG ADMINISTRATION______________________________________ ___________ Note that the Inspector's responsibility is principally to inspect for possible product contamination with a manufacturing process, and is not to examine the tech nology of the process itself. Naturally, it is not proper to reveal confidential process information. It is in order, however, for him visually to inspect house keeping, cleanliness, and sanitation as they may affect the end-product. 4. 'Warehouse and Shipment Records Ca) The permissible area for FDA inspection includes warehousing facilities within the plant area which are utilized for the storage or handling of inspectable products shipped or to be shipped in interstate commerce. The Inspector's attention will likely be directed particularly to house keeping, cleanliness, orderliness or arrangement, and the storage of food, drugs, and cosmetics at a safe distance from toxic materials. Cb) It should be noted that the Inspector is entitled to have access to and to copy certain records kept by carriers transporting inspectable products in interstate commerce and warehouses and others re ceiving such products from interstate commerce, showing the following: Cl) The movement of such products in interstate commerce; (2) The holding of such products iduring or after interstate movement; C3) The quantity of such products shipped or held after shipment; C4) Shipper's name; and (5) Consignee's name. Those parts of the company which may be subject to such inspections should permit the Inspector to look at and copy such records ONLY after obtaining from the Inspector a written statement describing the nature or kind of food, drug, device or cos metic covered by his request for inspection. A LAM006219 ORIGINAL ISSUE* 1-10-64 REVISED: 12-21-78 PAGE OFH 'I' " PROCEDURE BULLETIN--texas city plant p-qm>7 INSPECTION OF MANUFACTURING FACILITIES BY THE FOOD AND DRUG ADMINISTRATION _________________________________ __ failure to obtain such a statement from the Inspec tor may mean that any evidence of violation of the Act contained in such records can be used in a criminal prosecution of the person from whom the records were obtained. 5. Package Labels The Inspector shall be permitted to inspect labels for FDA-inspectable products and will be given samples of such labels on request. 6. General Technical Literature Technical bulletins designed for customer use, trade literature, and reprints of papers that have appeared in the technical journals often answer many of the questions of the Inspector. These should be freely given to him. Additionally, the Inspector should be referred to appropriate literature published in the technical journals. 7. Information and Items Relative to Prescription Drugs The FDA's inspection authority relating to establish ments manufacturing, processing, packing or holding prescription drugs is far more comprehensive than that relating to other establishment inspections. It covers all things bearing upon any adulteration or misbranding of prescription drugs except: ta) Financial data; Cb) Sales data other than shipment data; (c) Pricing data; Cd) Personnel data other than that relating to qualifi cations of technical and professional personnel performing functions subject to the Act; te) Research data other than data otherwise subject to reporting to the FDA. Prior to showing any such information to the Inspector, the Plant Representative must confirm with the ap propriate Division Representative and the Law Depart ment that the product at issue is in fact a prescrip tion drug product under the Act. 005009 ORIGINAL ISSUE: 1-10-64 REVISED: 12-21-78 LAM006220 PAGE_L_OFil PROCEDURE BULLETIN--texas city plant P-0907 INSPECTION OF MANUFACTURING FACILITIES BY THE FOOD AND DRUG ADMINISTRATION______________ ____ __________ 8. Marginal Information Not Covered by the Act In the normal course of events, the Plant Representative will politely decline to disclose information not spe cifically described in this Manual. However, should questions arise concerning the Inspector's authority to examine any such information, the Plant Representa tive will request the Inspector to put his request in writing for review by the Law Department. G. Information Not Covered by General Establishment Inspection of the' 'Act......................................................................................................................... Following are categories of items that the general estab lishment inspection provisions of the Act do not require us to disclose and that the Plant Representative will not reveal to the Inspector except as permitted in Section V, Part F. 1. Files, Books and Other Records In the event of a general establishment inspection, the Act does not require the Company to provide ac cess to any files, books, or other records.* For example, complaint files, personnel files, processing records, production rates, and manufacturing processes ordinarily will not be shown to the Inspector. In special cases, however, the Plant Representative may ,, seek clearance from the Divisional Representative and the Law and Patent Departments to permit the Inspector to examine such documents. 2. Operating Data The law does not require us to submit operating manuals, process descriptions, and similar records and procedures to the Inspector. Furthermore, we are not required to show operating log sheets (blank or filled out), strip charts, or other recorded data. Obviously the Inspec tor, during his visual inspection, will have an oppor tunity to look at guages, recorders, etc. This is proper. Thus, only operating data that he can directly observe is inspectable. But note exceptions in Section V, Part F, Subparts 4 (b), re lating to certain warehouse and shipment records, and 7, re lating to prescription drugs. 005010 ORIGINAL ISSUE: 1-10-64 REVISED: 12-21.78 LAM006221 PAGE1_0F1 PROCEDURE BULLETIN TEXAS CITY INSPECTION OF MANUFACTURING FACILITIES BY THE FOOD AND DRUG ADMINISTRATION______________ If the Inspector requests a description of any manufac turing or technical process, he should be referred to public technical literature containing general process descriptions. 3. Photographs and Sketches; Tape Recorders The FDA instructs its Inspectors to bring a camera with them on their inspections and to take pictures which may be of use as evidence in proceedings for violations of the Act. They are also instructed not to ask man agement's permission to take photographs. The Inspec tor is to be treated like all outside personnel with respect to taking photographs and paragraph V. J of Plant Procedure P-0700 should be followed. Should the Inspector take a hidden camera into the plant on the inspection, the Plant Representative should ask the Inspector to turn over the camera to the plant during the remainder of the inspection and should also request copies of any pictures taken inside the plant. The Inspector is not permitted to make detailed sketches of processes and equipment since this may reveal trade secrets and confidential process information, nor is he permitted to use tape recorders or similar devices during an inspection. Should an Inspector question such refusal, the Plant Repre sentative should ask the Inspector to submit a written request, to be reviewed by the Law Department, for permission to use such a device. 4. Customer Lists and Shipping Data The Plant Representative may disclose to the Inspector the names of only those customers who have granted permission to be identified as customers of Monsanto. Lacking specific information to that effect (which will be supplied to the plants by the Division Representative), the Plant Representative shall decline to identify our customers or give invoices of outgoing material. This is commercial information which some customers do not wish us to disclose. (But see Section V, Part F, 4 (b).) 005011 ORIGINAL ISSUE** 1-10-64 REVISED: 12-21-78 LAM006222 PAGE -LLOFJJ. PROCEDURE BULLETIN--texas city plant p~0907 INSPECTION OF MANUFACTURING FACILITIES" BY ^ ' THE FOOD AND DRUG ADMINISTRATION 5. Cost Data Since cost data and volume data (dollars and pounds) are extremely confidential, they shall not be disclosed to the Inspector. 6. Specifications The Plant Representative shall also decline to give specification tolerances regarding functional prop erties that could be unique to our product or unique to special applications. For drugs, only those limits given din the official United States Pharmacopoeia, National Formulary, or the Homeopathic Pharmacopoeia should be disclosed. Similarly, for food additives, only those limits given in the Food Chemicals Codex are subject to disclosure. 7. Non-Inspectable Areas The Inspector shall not be taken to any part of the plant that does not involve products listed as inspectable on the plant product list. Multipurpose equip ment used for inspectable products, but not currently in production of the inspectable product, is not in spectable. It may be necessary for the Plant Representative to politely decline to ""give certain items of information or .to show the Inspector certain parts of the plant. Should this be necessary, the Plant Representative shall explain the basis for his action in a casual and friendly manner, attempting to satisfy the In spector that the information or areas in question are not relevant to the product under inspection or to the enforcement of the Act. Should the Inspector be dissatisfied with the polite refused, to disclose information not covered by the Act, the Plant Representative should suggest that the Inspector submit a written request covering the in formation or areas at issue. H. Safety The Inspector will be required to follow all standard plant safety regulations during the course of his inspection. 005012 LAM006223 ORIGINAL ISSUE.* 1-10-64 REVISED: 12-21-78 PAGE 1L 0F-i2 PROCEDURE BULLETIN --TEXAS CITY PLANT p^Q9Q7 INSPECTION OF MANUFACTURING FACILITIES BY THE FOOD AND DRUG ADMINISTRATION ______ I. Completion of inspection At the completion of the factory inspection, the Plant Representative will take the Inspector back to the Plant Manager for a brief review of the inspection. If the Inspector has any adverse comments regarding filth, improper sanitation, or other conditions or practices re lating to a possible violation, he is required by the Act to submit them in writing (FD Form 483, LIST OF OBSERVAT IONS, for food, cosmetics and devices, and FD Form 2275, DRUG INSPECTIONAL OBSERVATIONS, for drug products) to the responsible officer (the Plant Manager) before leaving the premises. However, if the Inspector does not submit such a written report, he should not be asked for it since the absence of a report indicates that the inspector has not found violations. Should any subsequent report concerning the inspection be received from FDA, the Plant Representative or Plant Manager will immediately contact the Division Representa tive and the Law Department to develop an appropriate act ion plan. \ J. Plant Representative's Inspection Report Within three working days following an inspection, the Plant Representative shall submit copies of a complete written report to the Division Representative, the MICC Representative, the MICC Law Department, the Corporate Medical Department, the Plant Manager, and other ap propriate members of plant management. Should any situations or Inspector's comments warrant it, the Plant Representative shall telephone the Division Representative at the first opportunity on the day of the inspection. Reviewed By: G. W. Bostick P. E. Brubaker J. E. Clark G. A. Danner G. W. Daues W. C. Fuller ) J. A. Glass R. C. Martini C. M. McCullough D. W. Metten G. T. Ryan G. E. Small J. G. Trafton W. H. Triplett M. L. Owens Revised By A..H. Conrad Approved By P. EF' Brubaker SC 005013 LAM006224 ORIGINAL ISSUE: 1-10-64 REVISED: 12-21-78 PAGE-LLOF-iJ PERSONS RESPONSIBLE FOR FDA CONTACTS APPENDIX A P-0907 DIVISIONAL REPRESENTATIVES: Plastics & Petrochemicals Mice PLANT REPRESENTATIVES: Plastics & Petrochemicals MICC L. P. Paradis J. C. Weber G. W. Daues A. H. Conrad G, King (Alternate) J. G. Trafton (Alternate) SC 005014 1-10-64 12-21-78 L/M\(l006225 11