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

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

Sep 16, 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

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 01, 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