Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

USFDA issues Warning letter to Intas; Ci

USFDA issued a Warning letter to Intas, Matoda, Ahmedabad facility on 21 November 2023. This

Beta Lactam Contamination: Scynexis Reca

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

Potential cross contamination with ßlac

SCYNEXIS issued the recall of 2 lots of BREXAFEMME (ibrexafungerp tablets) due to Potential for

VistaPharm (USA) recall Sucralfate Oral

Florida based  VistaPharm LLC is recalling in US one lot of ulcer treatment drug Sucralfate

Warning letter / Centaur / July 2023 / C

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

Strides recalls Losartan Potassium table

Strides recalled 2700 bottles of Losartan Potassium USP 25 mg tablets in US for presence

Concerns of Beta Lactam Contamination: U

Warning letter / Centrient India / MARCS-CMS 640196/ 320-23-06/ DECEMBER 07, 2022/ Observation 2 USFDA

Cross Contamination Concerns: FDA Warnin

In September 2022, USFDA issued a Warning letter to Lupin API facility at Tarapur, India

USFDA Warning letter to Mylan on Handlin

USFDA Warning letter to Mylan in 2020 cited inadequacy of cleaning, cleaning procedures, risk assessment of