Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

FDA 483 to Jubilant : Data Integrity con

USFDA inspected Jubilant Generics Limited facility in Roorkee, India, from January 25th to February 2nd,

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

EUGIA India FDA483: Critical Data Integr

Aurobindo arm Eugia Pharma site at Sangareddy, Telengana was inspected by USFDA in Jan -Feb

USFDA483 to Aurobindo’s Eugia US Site

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

Warning letter / Medgel / July 2023 / In

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

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

USFDA 483 (Aug 2021) & Warning lette

Aurobindo Unit 1 (FEI 3004021253) was inspected by USFDA investigator Rita K Kabaso from August

IPCA USFDA 483 Flags Delayed Failure Inv

USFDA 483 / IPCA Laboratories, Silvassa, India / FEI 3005977675/ USFDA Investigators: Rajiv Srivastava, Kellia