Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Zydus Vadodara USFDA 483 cites Contamina

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

Eugia US LLC Recall one more Drug in US

Eugia US LLC is recalling one lot of Methocarbamol Injection in US for white particles

USFDA 483 to Eugia Polepally unit cites

USFDA had inspected Aurobindo’s Eugia SEZ Pvt Ltd facility at Polepally, Telengana in India in

Warning letter to Jordans Amman Pharma:

FDA issued a Warning letter to Amman Pharmaceuticals following inspection at the facility (FEI 3013501887)

USFDA483 to Aurobindo’s Eugia US Site

USFDA audit of Eugia US Manufacturing in New Jersey, US (FEI 3015534630) resulted in issuance

Insanitary Conditions, Non-Aseptic Pract

USFDA Inspected Indian drug manufacturer Kilitch facility in Mumbai (FEI 3011853060) in Oct 2023. USFDA

USFDA 483 to Panacea Biotec Cites Inadeq

Panacea Biotec, Baddi facility was inspected by USFDA in Oct 2023- investigators Sandra A Boyd

Warning Letter to US Eye Drop Manufactur

The USFDA Warning letter to K. C. Pharmaceuticals issued in August 2023, following inspection at

Biocon Malaysia USFDA 483 Cites Inadequa

Biocon Malaysia was inspected by USFDA Investigators Eileen A. Liu, Patty P. Kaewussdangkul, Daniel Lahar,

USFDA 483 / Intas / May 2023 /Failure to

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