Warning letters, 483s, Recalls, Import Alerts, Audit observations
Indoco Remedies’ Goa Plant (FEI 3005124189) received a warning letter from the FDA following critical
Authored by: Venkiteswaran.T.K, Subrangshu Chourdhary, Srinivas Churya Jubilant Generics Roorkee facility was inspected in January
Laurus Synthesis was issued an Untitled Letter by USFDA in May 2024, following critical observations
As expected FDA has taken regulatory action and issued a Warning letter to Natco, following
USFDA inspected Jubilant Generics Limited facility in Roorkee, India, from January 25th to February 2nd,
Eugia US LLC is recalling one lot of Methocarbamol Injection in US for white particles
USFDA had inspected Aurobindo’s Eugia SEZ Pvt Ltd facility at Polepally, Telengana in India in
Aurobindo arm Eugia Pharma site at Sangareddy, Telengana was inspected by USFDA in Jan -Feb
USFDA audit of Eugia US Manufacturing in New Jersey, US (FEI 3015534630) resulted in issuance
Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate
