Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

Laboratory Incidents and Validation Failures Lead to USFDA Warning Letter for Cdymax

Nov 25, 2025

Hetero USFDA Form 483: Unregistered Testing Lab, Undocumented Warehouse

Oct 18, 2025

Qvents Apps and Tools For QMS and GMP Processes

Sep 23, 2025

Zydus Recalls Antipsychotic Drug for Nitroso Desmethylchlorpromazine NDSRI

Sep 23, 2025

Metallic Particles in APIs, Complaint Investigation Flagged in Hikal Warning Letter

Sep 16, 2025

Alembic Recalls Anti-depressant Medicine for NDSRI Nitroso Desmethyldoxepin

Aug 24, 2025

Shiva Analytical Warning Letter: Data Integrity, Deficient OOS Handling Cited

Aug 14, 2025

Glenmark Warning Letter Cites 21 CFR 211.192 Violations at Multiple Sites

Aug 07, 2025

Natco Pharma USFDA 483 Flags Deficiencies in Aseptic Areas, Validation

Aug 02, 2025

Loss of Potency: Accord / Intas Recall Hypothyroidism / Thyroxine Drug

Jul 25, 2025

Nitrosamine Impurities in Pharmaceutical Products: Templates for Risk Assessment and Supplier Evaluation

Jun 28, 2025

Supply Chain Traceability of Medicinal Products

May 31, 2025

Continuous Process Verification (CPV) and Evaluation Templates

May 16, 2025

Concerns of Beta-lactam Contamination Triggers Massive Recall by Glenmark

Apr 28, 2025

Excipient Risk Assessment: Approach, Templates

Apr 24, 2025

Chattem Inc Recall Antihistamine Sleeping Aid Drug Due to NDSRI Impurity

Apr 15, 2025

Qualification of Inhouse Reference Standards and Secondary Standards

Apr 14, 2025

USFDA 483 Cites Piramal Pharma for Investigation Deficiencies, Procedural Non-Compliance

Mar 13, 2025

Contamination Control and Data Integrity Issues: Granules India Receives USFDA Warning Letter

Mar 07, 2025

Janssen’s Korea Vaccine Unit USFDA 483 Cites Aseptic Operations Not in Control

Feb 26, 2025