Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Alembic Recalls Anti-depressant Medicine

Alembic recently initiated recall of antidepressant drug Doxepin Hydrochloride Capsules (10 mg) in US for Nitrosamine

Shiva Analytical Warning Letter: Data In

The USFDA has issued a Warning Letter to Shiva Analyticals’ Bangalore facility following significant cGMP

Glenmark Warning Letter Cites 21 CFR 211

USFDA Warning letter to Glenmark Facility at Pithampur (FEI 3008565058), cited cGMP violations at multiple

Natco Pharma USFDA 483 Flags Deficiencie

Natco Pharma’s sterile products manufacturing facility at Rangareddy, Telengana (FEI 3004540906) was inspected by USFDA

Chattem Inc Recall Antihistamine Sleepin

With timelines closing in for drug product manufacturers to finalize their nitrosamine risk assessments, recalls

USFDA 483 Cites Piramal Pharma for Inves

Piramal Pharma’s API unit at Navi Mumbai (FEI 3008763768) was issued USFDA Form 483 with

Purified Water System Qualification and

The FDA inspected Colgate-Palmolive/Tom’s of Maine, Inc’s Sanford facility in the US in May 2024.

NDSRIs: Glenmark Recalls Several Lots of

Glenmark Pharmaceuticals is recalling several lots of the cardiovascular drug Carvedilol in US due to

FDA Warning Letter to Viatris: Concerns

Authored by: Venkiteswaran.T.K, Srinivas Churya FDA has published the Warning Letter issued to the Viatris Pithampur facility in December

Growing Trend of Drug Recalls for NDSRIs

Adding to the number of recalls during 2024 for NDSRIs, Ascend (Alkem) is recalling the