Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Warning letter / Centaur / July 2023 / C

Centaur India formulation facility at Pune, Maharashtra, India was issued Warning letter by FDA citing

Warning letter / Medgel / July 2023 / Fa

Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate

Warning letter / Medgel / July 2023 /Lap

Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate

Warning letter / Medgel / July 2023 / In

Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate

Warning letter / Centaur / July 2023 / F

The Warning letter cite Failure of Quality unit in ensuring cGMP compliance, Inadequate control over

Warning letter (2019) / Cadila, India /

USFDA Inspection at Cadila Ahmedabad, India in April-May 2019 by Investigators Justin A Boyd, Thomas

USFDA 483 (Aug 2021) & Warning lette

Aurobindo Unit 1 (FEI 3004021253) was inspected by USFDA investigator Rita K Kabaso from August

USFDA 483 (Aug 2021) & Warning lette

Aurobindo Unit 1 (FEI 3004021253) was inspected by USFDA investigator Rita K Kabaso from August

USFDA Warning letters, 483s, WHO Alerts

Potential contamination of drug products with Diethylene Glycol(DEG), Ethylene Glycol(EG) has severe consequences including fatality

Warning letter / Glenmark, Goa, India /F

USFDA Warning letter to Glenmark cites deficiencies in Out of specification (OOS) investigations, firms response to