Quality: Be Ready for the FDA
R. F. Stier. Consulting Food Scientists, Sonoma, CA. Cereal Foods World 53(4):242-243.
One of the commonalities in third party audits is a section of regulatory compliance and preparation for visits by the U.S. Food and Drug Administration (FDA). This is a commonsense request and it is a very, very good idea to be sure that your company has developed and implemented such a policy. Implementation in this case must include training of management, office staff, and line workers. According to federal law, the FDA has the right to come to your plant at any time during business hours. The agency has husbanded their resources and focused more on processing operations that pose greater risks to the public. However, they do believe that it is important that all processors and ingredient manufacturers in this country are inspected on a regular schedule. So, expect to be inspected by the FDA or a local agency representing them. And, be sure to develop a program to handle these inspections. This column provides information on how to prepare for such visits, including preparation for an inspection; how to act during the inspection; and follow-up to the inspection.