Discussion forum for Pharma Quality events, Regulatory Actions

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

USFDA Issues Guidance for Impurity Specifications for Semi-Synthetic & Fermentation Antibiotics

Apr 21, 2026

Responding to FDA Form 483: USFDA Issues Guidance

Apr 02, 2026

Qvents Apps and Tools For QMS and GMP Processes

Feb 17, 2026

Unichem Recalls Hypertension Tablets for Nitrosamine Impurity

Feb 16, 2026

USFDA 483 to Pharmathen Flags Deficient Aseptic Operations

Feb 05, 2026

Imprimis Recall Unapproved Ophthalmic Injections for Glass Particulates in US

Jan 05, 2026

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

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