Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Test Post (2)

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Natco Pharma USFDA 483:Cleaning deficien

Natco Pharma (india) Kothur facility was inspected by USFDA (Investigators Pratik S. Upadhyay and Saleem

The Quality Insight Test Post

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Watch these hungry waxworms eat through

Wriggling critters armed with enzymes can break down plastics that would otherwise take decades, or

USFDA approves Santhera’s New Molecula

Vamorolone is a synthetic corticosteroid approved by USFDA for the treatment of Duchenne Muscular Dystrophy

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 / In

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

USFDA 483 / Intas / May 2023 /Failure to

USFDA 483 to Intas cites lapses in investigation and review of failures and discrepancies in

USFDA 483 / IPCA / June 2023 /Failure of

USFDA Inspected IPCA (Ratlam, India) site in June 2023, Inspectors – Rajiv R Srivastava, Salim