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

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

Feb 26, 2025

Aarti Drugs USFDA 483 Flags Unique Challenges of Generic Pharma Companies

Dec 16, 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

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

Zydus Jarod Facility Classified OAI

Jul 22, 2024

Warning letter Sun Pharma Dadra Unit: Ineffective Quality Systems

Jul 16, 2024

Sun Pharma Dadra USFDA 483 cites Lack of Quality Oversight

May 20, 2024

Cipla Patalganga USFDA 483 highlights Cleaning and Maintenance issues

Apr 30, 2024

Sichuan Deebio – 483, OAI and Warning letter.

Mar 08, 2024

USFDA 483 to Laurus: Lapses in cleaning, documentation.

Feb 18, 2024

USFDA 483 to Laurus cites deficiency in sampling, uniformity not assessed.

Feb 14, 2024

USFDA 483 to Laurus: Lapses in investigation of equipment damage, OOS

Feb 14, 2024

USFDA 483 /Dr.Reddys (DRL) / October 2023 / Lapses in Quality Control Area

Dec 24, 2023

USFDA 483 to Dr.Reddys (DRL) : Cleaning Deficiencies, Building Maintenance Issues

Dec 19, 2023