surviving FDA Inspections: What Regulators seek
US FDA On-Site Inspections
Regulatory compliance onsite inspections are required by statute for producers in the USA and Foreign Food Facilities--the FDA Food Safety Modernization Act (FSMA). These onsite inspections evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act and other laws administered by FDA .
Ongoing Preparation
Every food production organization which processes food for sale inside the USA need to prepare for US FDA on-site inspections.
What Regulators Expect
Regulators expect complete and ongoing compliance with all US government laws, statutes, regulations, and rulings. Providers are expected to be current with all suggested practices or upon inspection will be cited or formally notified in the exit conference or later by formal letter.
Compliance Program Documentation
Regulators also expect that all required documentation should be current and properly recorded and accessible upon request at the onsite inspection. Providers are required to produce all documents upon demand or deliver them within reasonable notice.
Remote Regulatory Assessments
US FDA Remote Regulatory Assessments
US FDA Remote Regulatory Assessments will be used beyond the COVID-19 pandemic, as a modernizing step to inspections of food producers both within the USA and in foreign locations.
Voluntary and Mandatory Program Assessments
Most Remote Regulatory Assessments (RRAs) for food companies will be voluntary, but Remote Regulatory Assessments will also be used to conduct mandatory Foreign Supplier Verification Program inspections. The required compliance steps as defined in statutory or regulatory authority for your company in a Remote Regulatory Assessment will vary based on the product, location, history of your operation.
RRAs may include interactive evaluations:
- Remote livestreaming video of operations
- Teleconferences
- Screen sharing via internet platforms
- Online requests to review records
The FDA uses these methods to:
- Conduct oversight
- Mitigate risk
- Meet critical public health needs
- Assess compliance of FDA rules, regulations, guidelines
- Determine the adequacy of corrective actions from previous investigations
- Identify unreported adverse events
Further information is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conducting-remote-regulatory-assessments-questions-and-answers
AME Certified PCR Laboratories is available to consult regarding any of these issues.