Document kmLQ0KQponrv4YgYz4N92YvNE

Circular Bulletin To: All Locations Dept. Production No. 121 Date October 12, 1967 Subject: REGISTRATIONS AND INSPECTIONS BY FOOD AND DRUG ADMINISTRATION (FDl) Quality Control Procedure - 13 1. Hie purpose of this Bulletin is to establish a procedure covering: a) Location drug registration under the Federal Food, Drug and Cosmetic Act and its 1965 Drug Abuse Control Amendments. b) Location inspection by authorized FDA personnel under the Drug, and Cosmetic Act. c) Location Inspection by authorized FDA personnel under the Federal Hazardous Substances Act. 2. Bach location executive is responsible to: a) Designate at least one responsible individual to acquaint himself with this procedure and other correspondence on this subject and participate in inspections or to act as the executive's alternate whenever necessary to do so. All in spections are to be scheduled to coincide with the presence of the location executive, his designated alternate, or both individuals. b) Cooperate with FDA authorized personnel in order to facilitate Inspections and to avoid disruption of work schedules c) Maintain applicable operations at locations in accordance with Good Manufacturing Practices. 3- Location drug registration is required annually if USP, NF or other drug products are made, blended, repackaged or relabeled or if items covered by the Drug Abuse Amendments are wholesaled, Jobbed or dis tributed. Simply, drugs are products used as is or further processed for treatment of disease or which affect body functions in man or animal. k. >..fwextof your products, other than USP or NF & - f0r aj-ug purposes, advise this office at 'V - 5- LocatD^P^'<^HKl'iiig'food grade chemicals (food additives) are not required%; iia'ter but are subject to FDA Inspection under the Food, Drug and Cosmetic Act. 6. Hie procedure for drug registration by the location executive or his designated alternate is: Ml i SUGGESTED RETENTION I I Destroy After Noting I I Destroy After Complying Deetroy After 1~H Return With Comments ASI 00002334 m 2- - Initial Registration A. Contact Legal Department to obtain copies of PD 1597 Registration forms and instructions. B. Complete form and return to PM. C. PDA. will return validated copy of completed form. D. Forward copies of validated form to: Legal Department and Director of Production, Chemical Control. Annual Re-registration IT. PDA will forward annually form FD 1597 - for re-registration. B. Complete form and return to PDA. C. PDA will return a validated copy of completed form. D. Forward copy of validated form to: Legal Department. E. If form has not been received from PDA by December 15th of any year, contact Legal Department for instructions. Special Hote: Failure to register is a crime subjecting violator to all penalties of the Act, and renders all applicable products misbranded. Registration is not required by the Hazardous Substances Act. Die pur pose of this act is to assure that all hazardous substances intended or suitable for household use have proper labeling. A hazardous substanc is a substance or mixture of substances which is toxic, corrosive, an Irritant, a strong sensitizer, flaanable, or which generates pressure through decomposition, heat or other means, if such substance or mix ture of substances may cause substantial personal injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable handling or use, including reasonably foreseeable inges tion by children. 8. Under both the Pood, Drug & Cosmetic Act and the Hazardous Substances Act, the PDA has been given the authority to inspect manufacturing and distribution facilities and equipment. described in the following tables: Federal Hazardous Substances Act ame notice of inspection to the location executive or to an authorized Company representative in charge of a facility. ASI 00002335 3- - Item (2)Inspector authorized to: (3) Purpose of Inspection (h) Scope of Inspection Federal Food, Drug & Cosmetic Act Inspect such location at reasonable times, within reasonable limits and in a reasonable manner. Federal Hazardous Substances Act a) Inspect such location at - reasonable times, within reasonable limits and in a reasonable manner. b) Obtain samples of such ma terials or packages thereof or of such labeling. Determine whether foods. drugs or cosmetics (a) which are misbranded or adulterated, or (b) which are prohibited have been or are being (a) manufactured (b) processed (c) packed (d) transported or (e) held in each location. Determine if drugs which are covered by the Drug Abuse Amendments are being: a) manufactured b) compounded c) processed, or d) distributed by or to unauthorized persons. Determine whether the labels in use for the various finish d products meet the requirements of the act. Determine the composition of the various materials used in the manufacture of such hazardous substances. Subject to inspection are nt equipment, id unfinished maitainers and la- $n the factory, ware^`nstablistment or Same Specifically, the inspection covers the following items bearing on violations of the Act: a) Records b) Files c) Complaints d; Papers e) Processes f) Controls g) Facilities Bie Inspection covers items bear ing on the composition and label ing of hazardous substances. ASI 00002336 - 3- Item (2) Inspector authorized to: (3) Purpose of Inspection (^) Scope of Inspection Federal Food, Drug & Cosmetic Act Inspect such location at reasonable times, within reasonable limits and in a reasonable manner. Federal Hazardous Substances Act a) inspect such location at reasonable times, within reasonable limits and in a reasonable manner. b) Obtain samples of such ma terials or packages thereof or of such labeling. Determine whether foods. drugs or cosmetics (a) which are misbranded or adulterated, or (b) which are prohibited have been or are being (a) manufactured (b) processed (c) packed (d) transported or (e) held in each location. Determine if drugs which are covered by the Drug Abuse Amendments are being: a) manufactured b) compounded c) processed, or d) distributed by or to unauthorized persons. Determine vhether the labels in use for the various finished products meet the requirements of the act. Determine the conposltlam of the various materials used in th manufacture of such hazardous substances. *-- i ` . V,, fr.` ^ ' * 'v V. Subject to inspection are nt equipment, |uad unfinished maleontainers and la in the factory, ware, mstablishment or Same Specifically, the inspection covers the following items bearing on violations of the Act: a) Records b) Files c) Complaints d) Papers e) Processes fj Controls g) Facilities Die inspection covers items bear ing on the composition and label ing of hazardous substances. ASI 00002336 -h- Item (4) Contin ued (5) Frequency Federal Food, Drug & Cosmetic Act Bie inspection does not cover: a) Financial Data b) Sales data (other than shipment data) c) Pricing data d) Personnel data (other than data as to quali fications of technical and professional per sonnel performing func tions subject to regu lation) Registered establishment must be inspected by FDA. personnel at least once every two years and may be inspected more frequently. Federal Hazardous Substances Act ___________________ _ The inspection does not cover: a) Files or formulae b) Research data c) Complaints d) Personnel Records e) Patent Information f) Production Figures g) Sales figures h) Products which are not hazardous substances $i " Ho prescribed frequency Nonregistered establish ments have no prescribed frequency. .10 When definite requests are made by FDA personnel for information which is not required to be disclosed under the Acts, ash for a letter detailing the information desired and send it to the Legal Department for further handling. Other responsibilities of the location executive or designated alternate are; a) Cooperate with authorized FDA personnel. b) Always accompany FDA representative while on premises of plant facility. :) Obtain a receipt for each sample of materials taken by FDA. I) results of all analyses of samples ta]ken, at the FDA furnish results of all analyses of food additives and hazardous sub- 1 on each FDA inspection or visit and Director of Chemical Control, to Legal De partment, and to Packaging Coordinator, Allied Advertising. 11. All questions concerning this procedure, the Acts it concerns and our actions to ensure compliance with the Acts should be referred to the Legal Department and to the Manager of Quality Control. (M4:gsv Carbon copies - see next page C. M. Murphy / Manager of Quality Control ASI 00002337 -5 - cc: Vice President, Mfg., Mr. W. C. Ruch Directors and Managers of Production Directors end Managers of Sales Director of Technical Service, Mr. J. F. Adams General Managers Manager of Warehouse Operations, Mr. M. B. Eisen Legal Department, Associate Counsel, Mr. B- E. Minford Allied Advertising, Packaging Coordinator, Mr. E. J. Hogan Production Supervisors Jacksonville Works, Supt.-Southern Plant, Mr. H. J. TYes--n Menasha Works, Supt.-Northern Plants, Mr. C. E. Ploudre f'cth ASI 00002338 I