By W.A. Gould (Auth.)
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Additional info for Current Good Manufacturing Practices/food Plant Sanitation
Evidence indicating that such a violation exists causes the food to be adulterated within the meaning of the act, even though the amounts of natural or unavoidable defects are lower than the currently established defect action levels. The manufacturer, distributor, and holder of food shall at all times utilize quality control operations that reduce natural or unavoidable defects to the lowest level currently feasible. (d)The mixing of a food containing defects above the current defect action level with another lot of food is not permitted and renders the final food adulterated within the meaning of the act, regardless of the defect level of the final food.
12) Batters, breading, sauces, gravies, dressings, and other similar preparations shall be treated or maintained in such a manner that they are protected against contamination. Compliance with this requirement may be accomplished by any effective means, including one or more of the following: (i)Using ingredients free of contamination. (ii)Employing adequate heat processes where applicable. (iii) Using adequate time and temperature controls. (iv) Providing adequate physical protection of components from contaminants that may drip, drain, or be drawn into them.
Immediate corrective action is required by the firm. Contaminated Product Recall Inspections are conducted when FDA has requested that a manufacturer or distributor recall a product that has violated the FD&C Act. Such inspections are conducted to assure that the violative product has been removed from the marketplace and kept out of distribution. If the products are still being distributed, FDA can initiate seizure or injunction proceedings. Current Good Manufacturing Practices Inspections (CGMP's Inspections) are conducted by FDA to ensure that the company and responsible individuals are aware of and adhering to FDA developed CGMP's.