Discussion forum for Pharma Quality events, Regulatory Actions

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

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

Facility Registration Violations, Refusal of Inspection: Jagsonpal Issued Warning letter

Feb 22, 2025

Purified Water System Qualification and Control: USFDA Expectations

Feb 11, 2025

NDSRIs: Glenmark Recalls Several Lots of Cardiovascular Drug

Feb 06, 2025

FDA Warning Letter to Viatris: Concerns on Data Integrity, OOS Investigations

Jan 06, 2025

Growing Trend of Drug Recalls for NDSRIs

Dec 21, 2024

NDSRI Nitrosocinacalcet: Aurobindo Recall Batches After DRL, Accord

Dec 21, 2024

Aarti Drugs USFDA 483 Flags Unique Challenges of Generic Pharma Companies

Dec 16, 2024

API Key SM Source Concerns: Lupin Recall 600000 Bottles of Hypertension Medication

Dec 05, 2024

Investigation Docs Outside EDMS, Hold Time Study Lapses: Jubilant USFDA 483

Nov 13, 2024

Data Integrity, Cleaning Issues: Granules India USFDA 483

Nov 06, 2024

Nitrosocinacalcet Nitrosamine Impurity Triggers Big Recall From Dr.Reddys, Accord

Nov 05, 2024

Strengthen Analyst Qualification, Reduce Human Errors

Nov 04, 2024

Deficiencies That Lead to Officiation Action, Warning Letter: Learnings From Eugia USFDA 483s

Sep 21, 2024

Global Calcium USFDA 483: Critical Data Integrity Issues

Sep 17, 2024

USFDA 483 to Torrent: Concerns on Handling OOTs and OOS

Sep 13, 2024

Eugia Bhiwadi Facility Classified OAI: What Leads to OAI Classifications

Aug 22, 2024

USFDA 483 to Biocon Points Lapses in Equipment Performance Qualification

Aug 14, 2024