FDA 483 to Jubilant : Data Integrity con
USFDA inspected Jubilant Generics Limited facility in Roorkee, India, from January 25th to February 2nd,
Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
Biocon Malaysia was inspected by USFDA Investigators Eileen A. Liu, Patty P. Kaewussdangkul, Daniel Lahar,
USFDA 483 to Intas cites lapses in investigation and review of failures and discrepancies in
Aurobindo Unit 1 (FEI 3004021253) was inspected by USFDA investigator Rita K Kabaso from August
USFDA 483 / IPCA Laboratories, Silvassa, India / FEI 3005977675/ USFDA Investigators: Rajiv Srivastava, Kellia