Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Eugia USFDA 483 Cites Inadequate Contain

Aurobindo arm, Eugia Pharma Specialities facility at Bhiwadi, Rajasthan was issued USFDA 483 with seven

Zydus Vadodara USFDA 483 cites Contamina

USFDA inspection of Zydus Life sciences, Vadodara facility resulted in USFDA 483 with 10 observations.

Teva recall Nortrel (Norethindrone and

In a Class 3 recall Teva initiated recall of one lot each of Nortrel and Nortrel

Stagnant water in Equipment duct, Microb

Sun Pharma initiated recall of several drugs manufactured at Dadra site (India) for cGMP deviation

Hospira recall several injectables for g

Hospira Inc., a Pfizer company announced recall of several injectable products in US for potential

FDA Untitled letter to Novartis: Signifi

FDA had issued USFDA 483 in December 2022 to Novartis US site at Morris Plains,

USFDA issues Warning letter to Intas; Ci

USFDA issued a Warning letter to Intas, Matoda, Ahmedabad facility (FEI 3003157498) on 21 November

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