Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

FDA Issues Repeat Warning Letter to Thai

The U.S. FDA issued a warning letter to International Laboratories Corp. (FEI 3006403166) following CGMP

USFDA 483 Cites Piramal Pharma for Inves

Piramal Pharma’s API unit at Navi Mumbai (FEI 3008763768) was issued USFDA Form 483 with

FDA Warning Letter to Indoco Remedies Fl

Indoco Remedies’ Goa Plant (FEI 3005124189) received a warning letter from the FDA following critical

Investigation Docs Outside EDMS, Hold Ti

Authored by: Venkiteswaran.T.K, Subrangshu Chourdhary, Srinivas Churya Jubilant Generics Roorkee facility was inspected in January

Inadequacy of Investigations, Root cause

Laurus Synthesis was issued an Untitled Letter by USFDA in May 2024, following critical observations

FDA Warning letter to Natco over Cleanin

As expected FDA has taken regulatory action and issued a Warning letter to Natco, following

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