Document M45QEJa1VvZ3kyaoVXV3mRv3x

J TELEPHONE HUDSON 3-6126 Manufacturing Chemists' Association, Inc. (FOUNDED 1872) ............ ....... 1 " 1825 Connecticut Avenue, N, W. Washington, D. C. 20009 June 25, 1968 TO: FOOD, DRUG, AND COSMETIC CHEMICALS COMMITTEE SUBJECT: FDA's Plant Evaluator System Gentlemen: Enclosed is General Delmorete letter of June 14, 1968 with enclosures for your information. Sincerely yours, T t, M. M. Hoover MMHiSjg Enclosures ASI 00001*944 DEPARTMENT OF HEALTH. EDUCATION, AND WELFARE FOOD AND DRUG ADMINISTRATION WASHINGTON, D.C. 20104 June 14, 1968 manufacturing chemist* ASSUCUIIOH, KC. Gentlemen: This special Issue of the Newsletter Is to acquaint trade associations with the FDA's new Plant Evaluator System (PET). FDA has received numerous requests for details on this system. The PEV system la a long-term project to accumulate data on manufacturing practices In specific Industries. The data will be obtained by the FDA Inspectors during establishment Inspections. By analysing the data FDA will be able to identify problem areas In specific Industries. The PEV system will not be used to rate Individual firms or determine their compliance status. Many of your member firms may have their operations reported under the PEV system. We believe it will be to their benefit If they are aware of the details of the PEV system. We are asking your assistance in making available to your member firms copies of the PEV'a as they become available.- Tour association may wish to reproduce additional copies for distribution to > your members. Because of the large number of firms that will undoubtedly be interested in the PEV system, the FDA is not able to make copies available to individual firms. We believe these FEV's will be useful to Individual firms In developing and/ or improving their self-Inspection programs. The ability of a firm to take a critical objective look at itself is very Important If quality la to be maintained or Improved. However, these firms must understand that key indica tors do not encompass all of the problem areas nor are they a substitute for other guidelines. The first group of PEV's are enclosed with this Newsletter as an example of their format and content. We are attaching a complete list of PEV's, including those that have issued as well as those In preparation. If you are Interested In receiving specific ones, please advise, A limited supply will be mailed to you as they issue. Your comments and suggestions concerning the value of this system in your member firms' quality control programs will be most welcome, and should be addressed to; Bureau of Voluntary Compliance (VC-1), Food and Drug Administra tion, 200 C St,, S.W., Washington, D.C, 20204. Sincerely, PEV Ho.02,16,18,21,22 List of FEV's ASI 00001945 LIST OF PEV's ISSUED AND IN PREPARATION PEV Title Small Volume Injectables Smoked fish ---------------Animal By-Products for Feeds Dry Milk Products ----------Frozen Egg ----------------- -------Shelled Tree Nuts ---------Dried Yeast ----------------------- - -- Natural Cheese -------- -------------Dried Egg --------------------------------Canned Infant Formula-----------Canned Fish --------------Fresh Blue Crab Meat ------ Large Volume Parenterals -*- Breaded Shrimp ------ -------- ---------Canned Vegetables --------------------------------Food Warehouses -------------- -------------------Fresh & Frozen Fish ----------------------------Frozen Potato Products ------------Macaroni & Noodles ------------------------*----Filled Bakery Specialties-------------------Standardized Chocolate Products --------------------------------------------Cosmetics -----------------------Sterile Disposable Devices-----------------i/ Drugs not Represented as or Required to be Sterile-------------- ----- ------------------- PEV Number 1 (Human) 23 (Veterinary) 2^ 3 4 5 6 7 8 9 10 11 12 13 (Human) 27 (Veterinary) 14 l16Vvr 11J 18 S 19 20 21 2i<y 24 25 (Human) 26 (Veterinary) June 14, 1968 ASI 00001946 PLANT EVALUATOR Food and Drug Administration Food Warehouses This FKV does not apply to salvage dealers and similar establishments. RAW MATERIALS 1. - 8. Not Deed. MANUFACTURING AND PROCESSING 9. Are all lots visually examined before being placed In storage and If contamination Is found or auanected, Is the lot segre gated, and either adequately reconditioned or rejected? 10. Are proper precautions taken In warehouse storage and in loading1 carriers (trucks, rail, etc.) to prevent chemical contamination of food products by effectively segregating toxic chemicals from foodstuffs? 11. Is the warehouse free of any evidence of the presence of dogs, cats, birds and vermin (Including but not limited to rodents and insects)? 12. Does the firm have a formal (written schedules and Instructions) sanitation and pest control program including at least weekly inspections made by a trained, qualified, and designated employee? 13. Are all rodentleldes, used In the warehouse, approved for such use In food plants; kept In secure tamper-proof containers. If warranted; and located an adequate distance from all food Items susceptible to contamination? 14. Are all other toxic substances, such as Insecticides which are used In the warehouse, approved for such use and employed in a manner to prevent contamination of foods? This PEV covers Commodity Codes: 47-0 Date Issued: May 27, 1968 ASI 00001947 Food Warehouses 2 FEV No. 16 15. Are all cold storage units equipped with an accurate and easily visible thermometer with the sensing element located at least five feet above the floor? 16. Are all cold storage refrigeration units maintained at a temperature equal to or less than 4QF? 17. Are all cold storage freezer units maintained at 0F or less? 18. Is there walk-through space between stored Items and walls, and are Items stored on pallets or the eoulvalent to avoid direct contact with the floor? 19. Does the firm maintain a morgue area for damaged and returned goods, which Is adequately separated from the storage area? 20. Does the firm maintain a program of tlsmly and proper disposal of morgue items to prevent the development of pest breeding places and harborages? 21. Does the firm maintain a program of stock rotation. Including adeeuate identification of each lot, to assure both a rapid and proper rotation of goods? 22. Is there adequate physical separation of bagged animal feeds, If stored by the firm, from human food storage? 23. Is the building suitable for food storage from a structural stand point (protection from elements and vermin)? 24. - 45. Not Used. FINISHED PRODUCT 46. - 55. Not Used. LABELING AND PKNCTIONAL 56. - 60. Not Used. ASI 00001948 PLANT EVALUATOR Food and Drug Administration Froien Potato Products _____ ________ ______________ HAW MATERIALS 1. Ara raw potatoas Inspected upon racalpt for sold, rot or other defects that render then unfit for human consumption? 2. Is the storage location for raw materials sufficiently sepa rated from the processing area to prevent Its contamination? 3. Does the firm control the application of pesticides to raw materials, or require a guarantee from the supplier that raw materials do not contain Illegal pesticide residues? 4. - 8. Not Used. MANUFACTURING AND PROCESSING 9. Is the plant free of any evidence of the presence of dogs, cats, birds and vermin (Including but not limited to rodents and in sects)? 10. Do all persons handling food Ingredients, or their contact sur faces, wear clean outer garments. Including hair-nets, headbands or caps, maintain a high degree of personal cleanliness and conform to hygienic practices? 11. Are hand dip solutions maintained at 100 ppm available chlorine, or equivalent, and are they used by employees? 12. Are surfaces of all equipment In direct contact with the food product thoroughly cleaned and sanitised each day prior to operation, between work shifts, and when necessary, during pro cessing? This PEV covers Commodity Codes: 43-9 Date Issued: May 27, 1968 AS1 00001949 Frozen Potato Product* -2- PEV No i 18 13. Are potato** adequately sorted, peeled, washed and trimmed to re* move all peel, rot, noId, parasitic damage, and other defects? 14. Are the storage locations for potentially dangerous chemicals (e.g. caustic solutions for peelings, sanitising chemicals. In secticides, etc.) sufficiently separated from the manufacturing area and are chemicals handled only by authorised personnel? 13. Is the water. In contact directly or Indirectly with the product, from an approved source (municipal supply or tested private source)? 16. Does the firm have an adequate solid and liquid waste disposal system? 17. Is the operation properly controlled through to the testing of the finished product to prevent time-temperature abuses? 18. Are the cooking oils In us* properly filtered and replaced as necessary to prevent a build-up of foreign material and rancidity? 19. Is the forced air used In the retrogradatlon and drying tunnels, precoolers, and freezers properly filtered? 20. Do temperature controls reveal that freezing Is uniform through out the product? 21. Are quality control records maintained? 22. Are bacteriological examinations routinely made of "In-line" samples? 23. Does the firm have a written,scheduled, sanitation program and Is It being followed? 24. Are food and color additives used In accordance with the Regula tions? 25. - 45. Not Used. FINISHED PRODUCT 46. Is the internal temperature of the frozen product maintained at 0F or lower? 47. Are recording thermometers used In strategic locations In the storage area? ASI 00001950 Frozen F teto Products - 3- FEV No: 18 48. Doe* the firm have lcroblologlcal specifleetlone to which the product oust comply? 49. Does firm withhold from distribution lots which do not meet the microbiological specifications? 50. Are products found to be contaminated, destroyed or reconditioned to eliminate the contamination prior to shipment? 51. Are storage containers for in-process, bulk and final products maintained under sanitary conditions? 52. Are products shipped under proper refrigeration (0F or lower)? 53. - 55. Not Used. LABELING AND PROMOTIONAL 56. Does the firm maintain an adequate inventory control system, which reflects the history of each lot from Its raw material stage through distribution of the finished product? 57. - 60. Not Used. ASI 00001951 PEV No. 21 PLANT EVALUATOR Food and Drug Administration Standardised Chocolate Products RAW MATERIALS 1. Is the receiving and storage location for raw materials suffi ciently separated from the processing area to prevent Its con tamination? 2. Are all Incoming raw materials Inspected for evidence of mold. Insect, animal, bird, and other contamination? 3. Are critical raw materials, (e.g. scrap or salvage chocolate, dried milk, etc.) received under the supplier's guarantee, or examined for bacteriological contamination prior to use? 4. Are raw materials quarantined pending results of analysis? l 3. Are rejected raw materials segregated and then either dlsp sed of, or reprocessed to eliminate the contamination? 6. Does the firm record and control the fumigation process of cocoa beans to ensure that residues are below tolerance? 7. Are all raw materials, and collateral materials used In their processing, stored under controlled temperature and humidity to prevent bacterial and mold contamination? 8. Are potentially dangerous chemicals (e.g. fumigants, boiler compounds, etc.) properly stored and handled In a manner to preclude contamination of the raw materials? MANUFACTURING AND PROCESSING 9. Is the plant free of any evidence of the presence of dogs, cats, birds, and vermin (Including but not limited to rodents and insects)? This PEV covers Commodity Codes: 13-2 Date Issued: May 27, 1968 ASI 00001952 Standardized Chocolate Producta 2 PEV Ho. 21 10. Does the firm maintain a scheduled sanitation program for the plant, including but not limited to the inspection and examin ation of air filters, dust collectors, vaeuup and floor sweep ings, and floor drains? 11. Are potentially dangerous chemicals (e.g. insecticides, sani tizing solutions, etc.) properly stored and handled in a manner to preclude contamination of the food? 12. Is the plant so designed and the equipment arranged to preclude erosa-contamlnation of ln-procese products? 13. Is traffic within the plant restricted and controlled to pre vent unnecessary cross-traffic between raw material and pro cessing areas? 14. Are the bags of raw materials brushed off before emptying? 15. Is the equipment furnished with dust collectors where necess ry? 16. Are sorting and stoning machinery operating properly to remove 1 foreign material? 17. Are magnets strategically located in the conveyor belts and other equipment to prevent the incorporation of metal particles in the finished product? 18. If fluid milk is used, is it pasteurised? 19. Is chocolate material, that drops on machinery or on the floor, destroyed rather than reclaimed? 20. Is the equipment constructed and positioned to avoid "dead spots" which hinder inspection and are not readily cleaned? 21. Are chutes, leading to mixers and cleaners, shielded or screened to prevent the introduction of foreign material? 22. Are Implements (e.g. brooms, shovels, etc.) identified for use in specific plant areas and not interchangeably used? 23. Does the firm refrain from using wooden utensils which come in contact with the product? 24. Are utensils properly stored and used to preclude contamination of the product and other equipment? ASI 00001953 Standardised Chocolate Products - 3- PEV Wo. 21 25. Ia static materia1 removed from equipment b?tvcen batches on a routine baais7 26. Are f' on In all processing areas readily cleanable and sloped to permit complete washing and drainage? 27. Are cocoa beans masted at mlrlmums of 180F (Internal bean temperature) for 15 minutes or an equivalent time-temperature ratio? 28. Are roasting ovens equipped with continuous recording thermom eters? 29. Is the time-temperature ratio for each roast checked by a re sponsible Individual? 30. Are precautions taken In the cooling area to prevent microbial recontamination? 31. Ia the cracking process accomplished promptly after the cooling process? 32. Are bean cleaning and roasting equipment adequately Isolated and partitioned off from other operations to prevent air-borne contamination of the roasted product? 33. Are all lights above the mixing, grinding, and conveying equip ment shielded? 34. Are the storage tanks and hoppers covered? 35. Is scrap chocolate collected and stored in closed, clean, san itary containers? 36. Does the management prevent any person affected with bolls, sores, infected wounds or other sources of potential pathogenic organisms from working In direct or Indirect contact with the food product? 37. - 45. Hot Used. FINISHED PRODUCT 46. Are all lots of finished products aseptlcaliy sampled for bac terial examination? ASI 00001954 Standardised Chocolate Products -4- PEV No. 21 47. Are representative samples collected from each lot to provide a minimum of 10 subsamples and la each of sufficient else to conduct appropriate microbial analyses? 48. Are the samples analysed for bacterial contamination, especially Salmonella? 49. Is the finished product withheld from distribution until quality control tests are completed? 50. Are finished products which are found to be contaminated, seg* regated and then destroyed or reproeesaed to eliminate the con* taminatlon? 51. Is the finished product handled and stored In a manner which precludes contamination? 52. 55. Not Used. LABELING AMD PROMOTIONAL 56. Does the firm maintain an adequate inventory control system, which reflects the history of each lot from Its raw material stage through distribution of the finished product? 57. - 60. Not Used. ASI 00001955 This PEV Is not applicable to the "cold smoked" fish Industry.* RAW MATERIALS 1. Are all fish received at the plant Inspected and only wholesome fish processed? 2. Are all fresh round and dressed fish thoroughly washed In potable water upon receipt? 3. Are holding temperatures for fresh fish maintained at 38F or below to prevent spoilage? 4. Is the raw material area free of any evidence of dogs, cats, , birds, and vermin (Including rodents and Insects)? 5. - 8. Not Used. MANUFACTURING AND PROCESSING 9. Are all frozen fish defrosted at recommended temperatures (water defrosting at 70F or below; air defrosting at 45F or below)? 10. Is evisceration of all round fish performed with a minimum disturbance of Intestinal tract content? 11. Is the removal of viscera complete? 12. Is the water used for washing fish from an approved source (municipal supply or tested private source)? 13. Does the firm have an adequate solid and liquid waste disposal system? 14. Are the eviscerated fish washed In potable water prior to brining?____________________________________________________________ This PEV covers Commodity Codes: 23-1* Date Issued: i;ay 27, 1968 ASI 00001956 Smoked Fish 2 PEV No. 0 2 15. Are **qulpfr:<?nt ,'nd vasM.ng surfaces cleaned end sanitized between different lots of fish? 16. 13 the temperature of the brining solution maintained at 38F or below? 17. Are analyses conducted to determine if the salt content in the aqueous phase of the loin muscle of the finished product is in excess of three percent? 18. Are all food additives used permitted and are their restric tions for use observed? 19. Is the cooling room used after smoking, a single purpose room? 20. Are the smoked fish cooled to a temperature of 38F or below Immediately following smoking? 21. Does the management prevent any person affected with boils, sores, infected wounds, or other sources of bacterial contam ination from working in direct or indirect contact with the food? 22. Is the process area free of any evidence of dogs, cats, birds and vermin (including rodents and insects)? 23. - 45. Not Used. FINISHED PRODUCT 46. Is the finished product handled, stored and packed in a sani tary manner? 47. Is packaging performed in a single purpose room? 48. Does the packaging adequately protect the finished product from contamination? 49. Is the finished product stored at a temperature of 38F (in ternal temperature) or below? 50. Are delivery trucke clean and refrigerated? 51. Is the finished product area free of any evidence of the presence of dogs, cats, birds and vermin (including rodents and insects)? A5I 00001957 Smoked Fleh - 3- PEV K . 02 52. - 55. Hot Uaed. LABELIMC AMD PROHDTIOHAL 56. Does the firm adequately label the product to Indicate Its perishable nature and to ensure Its storage at 38F (Internal temperature) or below daring shipment and while being held for sale? 57. Does the firm code Its product to Indicate the date of manu facture? 58. - 60. Mot Used. ASI 00001958 PEV No. 22 PLANT EVALUATOR Food and Drug Administration Coi tics RAH MATERIALS 1. Has the firm established specifications (nicrobiological, chemical, physical, etc.) for the raw materials used? 2. Are raw materials checked to determine compliance with the specifications, and rejected when they do not meet the specifications? 3. Are records maintained which relate the history of each lot of raw materials, including origin, smounts received, quality control checks, nse, etc.? 4. Are raw materials properly labeled or identified (lnclwdlng nec essary warnings and cautions) to prevent mix-ups or misuses? t 5. Do proper temperature end humidity conditions exist in the storage areas to maintain acceptable quality? 6. Are raw materials protected frem contamination by animals. Insects, and other sources? 7. - 8. Hot Used. MANUFACTURING AMD PROCESSING 9. Does the batch record Include an accurate reproduction of the master formula, and does the record accompany the.-product through the entire production process? 10. Bo bsteh formula Instructions provide Information such as, process ing temperatures, mining times, screen slses, etc.? 11. Dome the firm retain an adequate record of the formulation, weigh ings, and processing temperatures, etc. for each batch produced? This PEV covers Commodity Codes: 94-1/9 Date Issued: May 27, 1968 ASI 00001959 Cosmetics -2- m V t 22 12. Are the colors used safe for uao In cosmetics (exempt from certifi cation, or froa cartIflad batches)? 13. Is the plant so designed and so arranged to prevent eross-contam1nation of prodoetsl 14. Are product contact surfaces adequately cleaned and sanitised prior to use and between batches? 15. Are employees properly attired? 16. Are hand dip solutions aalatalned at 100 ppa available chlorine, or equivalent, and are they used by eaployeea? 17. Is the water. In contact directly or indirectly with the product, froa an approved source (aualclpal supply or tasted private source)? 18. Are quality control tests aade to ensure an homogeneous product? 19. Are quality control tests conducted at critical points In the process ing to detect bacteriological contaaluatlou In the equlpaent? 20. Is label control adequate to prevent mix-ups? 21. Are controls eaployed during packaging adequate to ensure aceurete quantity of contents and Identity of the labeled product? 22. Where batches are reworked, does the flra maintain adequate rec rds to determine the preductleu and analytical history of the product Including that of the original batch? 23. - 45. Wot Osed. PIWISWED flOPOCT 46. Was the flra established specifleatlous (microbiological, chemical, physical, ate.) for the finished product, and la any batch not asatlng the specifications withhold froa distribution? 47. Are finished products handled and stored In a suitable manner to maintain quality? 48. Is the product tasted prior to distribution to ensure the effective ness of added preservatives against the growth of nlcroorganlsas? ASI 00001960 C emetica -3- PET Ho: 22 49. Are pharmacological and chemical atndlee conducted prior to dis tribution on new products, or when signlfleant formula changes are made In thoee products previously marketed? 50. Does the firm retain reserve samples for determining microbio logical quality, effectiveness of preservatives, stability tests, etc.? 51. Does the firm review each complaint received, attempt to find Its cause, and make necessary changes In processing, formulation, etc.? 52. - 55. Dot Vsad. LABELIDC ADD fROHOTIOWAL 56. Are the products labeled with adequate directions for use (e.g., preliminary patch test) and proper caution legends and warnings? 57. Does the firm maintain an Inventory control system that can be used to facilitate rapid and effective recall If neeeasary? 58. - 60. Rot Used. ASX 00001961