Preparing for a US FDA Foreign Facility Inspection

digi — Mon, 02 Jun 2025 03:49:35 +0000

Preparing for a US FDA Foreign Facility Inspection How to Prepare for a US FDA Inspection at Foreign Pharmaceutical Facilities Pharmaceutical manufacturers outside the United States supplying to the US market must comply with stringent GMP regulations under 21 CFR Parts 210 and 211. As part of this oversight, the US Food and Drug Administration...

FDA Form 483 foreign site – Pharma GMP

Preparing for a US FDA Foreign Facility Inspection