Understanding FDA 483 Observations in CGT Manufacturing
CDMO Signal · 2026-05-23
An FDA Form 483 is issued at the conclusion of a facility inspection when investigators have observed conditions that may violate the FD&C Act.
Common 483 Categories in CGT
- Equipment and Facility — Environmental monitoring failures, cleanroom issues
- Production Controls — Deviations from SOPs, batch record deficiencies
- Laboratory Controls — OOS investigations, stability testing gaps
- Data Integrity — The most serious findings