Discussion forum for Pharma Quality events, Regulatory Actions

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

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

Mar 07, 2025

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

Feb 22, 2025

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

Jan 06, 2025

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

Sep 21, 2024

Warning letter Sun Pharma Dadra Unit: Ineffective Quality Systems

Jul 16, 2024

Inadequacy of Investigations, Root cause and CAPA – USFDA Untitled Letter to Laurus

Jun 02, 2024

Chine API Manufacturer Chengdu KeCheng Issued Warning Letter and Import Alert for Refusal of Information

May 01, 2024

Sichuan Deebio – 483, OAI and Warning letter.

Mar 08, 2024

Warning letter / Centaur / July 2023 / Cleaning deficiencies, failure of Quality unit

Sep 19, 2023

Warning letter / Medgel / July 2023 / Failure to test impurities, DEG&EG

Aug 23, 2023

Warning letter / Medgel / July 2023 /Lapses in Quality oversight, Data integrity

Aug 23, 2023

Warning letter / Medgel / July 2023 / Inadequate Investigation of OOS, deviations

Aug 23, 2023

Warning letter / Centaur / July 2023 / Failure of Quality Unit, Uncontrolled cGMP documents, Equipment Cleaning issues

Aug 07, 2023

FDA Warning letter to Zydus: Previous Residues in Cleaned Equipment

Jun 23, 2023

USFDA 483 (Aug 2021) & Warning letter (Jan 2022) / Aurobindo Unit 1, India / Deficient Change Management / USFDA Investigator Rita K Kabaso

Jun 20, 2023

USFDA 483 (Aug 2021) & Warning letter (Jan 2022) / Aurobindo Unit 1, India /Failure to investigate critical deviations / USFDA Investigator Rita K Kabaso

Jun 20, 2023

USFDA Warning letters, 483s, WHO Alerts on Diethylene Glycol (DEG), Ethylene Glycol (EG) contamination in Drug Products (Pharmaplast Egypt; Champaklal, India and others).

May 10, 2023

FDA Warning Letter to Glenmark Cites Lapses in Investigation for Content Uniformity Failures

Apr 18, 2023

Warning letter / DuPont Nutrition USA Inc. / MARCS-CMS 627211/ 627211/ DECEMBER 02, 2022/ Observation 1

Apr 18, 2023

FDA Warning letter to Dupont cites Inadequate OOS Investigations

Apr 18, 2023