Warning letters, 483s, Recalls, Import Alerts, Audit observations
Aurobindo arm Eugia Pharma site at Sangareddy, Telengana was inspected by USFDA in Jan -Feb
Sun Pharma initiated recall of several drugs manufactured at Dadra site (India) for cGMP deviation
FDA had issued USFDA 483 in December 2022 to Novartis US site at Morris Plains,
USFDA issued a Warning letter to Intas, Matoda, Ahmedabad facility (FEI 3003157498) on 21 November
Bayer is recalling one lot of Vitrakvi® (larotrectinib) Oral Solution 20 mg/mL in 100mL glass
Natco Pharma (india) Kothur facility was inspected by USFDA in October 2023. The site (FEI
Nectar Lifesciences was issued an Untitled letter (UL) by USFDA in Sep 23 citing deficiencies
Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate
FDA published the USFDA483 issued to Intas site (FEI 3003157498) in Ahmedabad, India after inspection
USFDA 483 to Sunpharma, Mohali unit in Aug 2022 cites deficiencies in Chromatographic integration and
