Browse by Topic

Navigate 483 Signal's library of FDA inspection analysis organized by GMP issue category and facility type.

GMP Issues

ALCOA violations, audit trail gaps, data manipulation, and 21 CFR Part 11 electronic records issues.

Sterility failures, contamination control, cleanroom violations, media fills, and Annex 1 compliance.

PPQ failures, continued process verification, and FDA process validation guidance gaps.

Dirty hold time failures, acceptance criteria issues, and cleaning method validation deficiencies.

OOS investigation failures, stability program deficiencies, and analytical testing issues.

IQ/OQ/PQ gaps, calibration failures, preventive maintenance, and facility design issues.

QMS failures, batch record review breakdowns, SOP lifecycle management, and documentation violations.

Root cause analysis failures, recurring deviations, CAPA effectiveness, and investigation deficiencies.

Vendor audit gaps, raw material testing failures, CMO oversight, and supply chain controls.