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FDA Guidance regarding Onsite Inspections during COVID19 (Q&A) - USA

After the publication of the Guidance for "Remote Interactive Evaluations", FDA has updated its "Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers Guidance for Industry", clarifying some of the plans to take when the agency cannot conduct an onsite inspection of a facility.

FDA acknowledges the fact that on-site inspection activities are "limited due to factors including travel restrictions" and "intends to continue using alternative tools, when appropriate, to evaluate facilities".

The document explains what FDA deems as "mission-critical" and how it will ensure the quality of imported products while inspections are limited.

US FDA Has Done Over 200 ‘Mission Critical’ Inspections During COVID

Check out these Inspection Guides by FDA

  • Biotechnology

  • Computer Issues

  • Devices

  • Drugs

  • Foods & Cosmetics

  • Miscellaneous

These documents are reference material for investigators and other FDA personnel.

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