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USFDA Inspection Types

The FDA and States assisting the FDA under contract or cooperative agreements, in general, perform three types of inspections: surveillance, compliance follow up, and for-cause. Surveillance inspections are conducted to assess a facility’s or farm’s compliance with a regulation or to focus on an emerging trend in food safety. Surveillance inspections fall into two categories, routine and targeted. Routine inspections of facilities and farms are conducted to assess regulatory compliance. The FDA Food Safety Modernization Act mandates an inspection frequency of at least once every three years for domestic high-risk facilities and at least once every five years for non-high-risk facilities. In addition, the Food and Drug Omnibus Reform Act of 2022 mandated annual inspections of infant formula manufacturers in accordance with a risk-based approach. If necessary, inspections can be conducted more frequently. The FDA seeks to achieve comparable coverage of imported foods using an array of re...
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Understanding Quantitative, Qualitative, and Limit Tests in Pharmaceutical Quality Control

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