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It seems this facility was operating as if not regulations exist. A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR Part 114.
During the inspection, the FDA investigator found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Foodregulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 Part CFR 117). Food and Drug Administration; Attn: Allison C.
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