Manufacturers - 1
through June 28, 1992.
21 CFR 108.35(h) and 21 CFR 108.25(g) requires LACF and acidified food processors to prepare, review and retain records of critical factor control; including thermal processing, processing deviations, and container closure inspection for three years (at least 1 year at the actual processing facility and 2 additional years at some reasonably accessible facility).
The FDA 482a is normally issued to the same person to whom the FDA-482, "Notice of Inspection" is issued. If this is not possible it should be issued to the next most responsible individual. A copy of the FDA 482a is submitted with the EIR.
Written Request for Information (FDA 482b) (Attached as Form #2)
21 CFR 108.35(c)(3)(ii) and 108.25(c)(3)(ii) requires that LACF and acidified food manufacturers shall provide FDA with any information concerning processes and procedures which are deemed necessary by FDA to determine the adequacy of the process. These include records on process establishment, such as heat penetration data, and temperature distribution data upon which the scheduled processes and procedures are based. Many processors will not have this data readily available. In fact, 21 CFR 113.83 requires only that the person or organization establishing the process permanently retain all records covering establishment of the process. The processor should, however, have in his files a letter or other written documentation (e.g. NFPA Bulletin 26L) from a processing authority delineating the recommended scheduled process and associated critical factors. Documentation on hand at the processor should include the establishment of venting procedures for steam retorts and the establishment of operational procedures (e.g. come-up times) for other retort systems.
The FDA 482b is issued to request the firms copies of scheduled processes, supporting documentation from a processing authority (e.g. letter or bulletin) and the documentation which delineates the venting or retort operational procedures.
The FDA 482b is not routinely issued to request detailed supporting documentation (e.g. heat penetration or temperature distribution test data) from a processing authority. However, when situations are encountered where you believe control of certain factors are critical to the process, and there is no evidence to document that these factors (e.g. a change in formulation that could effect consistency) were considered by the processing authority or listed on the filed scheduled process; after checking with your supervisor or LACF monitor, contact the Center for Food Safety and Applied Nutrition (CFSAN), Regulatory Food Processing and Technology Branch (HFS-617). If requested by the Center, obtain all available information about the situation, including the name or the person or organization who established the process and the specific practices of the firm and forward this information to CFSAN, Division of Enforcement (HFS-605) for review as soon as possible. If additional process establishment information is required CFSAN may request the information directly from the processor, who may have to obtain the data from the "processing authority", or CFSAN may request the district to obtain the information.
When retort design, construction or venting procedures do not match those detailed in 21CFR 113, copies of temperature distribution studies or a letter from a processing authority should also be obtained (also see Processing Authorities and Process Adherence section of this guide for additional information).
The FDA 482b "Request for Information" should be prepared by listing the specific information required. Specify each product involved by the food product name and form, container size and processing method (e.g. supporting documentation from a processing authority, or other source, for thermally processed french style green beans in 300 x 303 size cans or, e.g. Supporting documentation from a processing authority, or other source, for your firms 3 basket vertical retort vent schedule of 4 minutes to 220 ° F).
The FDA 482b is normally issued to the same person to whom the FDA 482, "Notice of Inspection" is issued. If this is not possible it should be issued to the next most responsible individual. A copy of the FDA 482b is submitted with the EIR.
Note the FDA 482, 482a and 482b are not issued during foreign inspections.
HISTORY OF EMERGENCY PERMIT CONTROL AND LACF REGULATIONS
Two botulinum episodes occurred during the summer of 1971. The first involved vichyssoise soup, and resulted in one death, and the recall of all 90 products manufactured by the firm. The next episode involved two soup products manufactured at another firm. Botulinum toxin was discovered in a few cans of chicken vegetable soup during a routine check for non-toxic spoilage. This led to the recall of