Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Test Post (1)

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The Quality Insight Test Post

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Medicine (CalmiRest)

CalmiRest is an herbal supplement designed to promote relaxation and alleviate mild anxiety. Formulated with

USFDA 483 / UCB Farchim SA/ June 2023 /

USFDA Inspected UCB Farchim site at Bulle, Switzerland (FEI 3005023799) in June / July 2023.

USFDA 483 / UCB Farchim SA/ June 2023 /

USFDA 483 / UCB Farchim SA/ June 2023 / Gaps in Data Integrity program, lack

Potential cross contamination with ßlac

SCYNEXIS recalled 2 lots of Brexafemme (ibrexafungerp) tablets in U.S. due to potential cross contamination

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