Tag: Control (Reserve) Samples

USFDA 483 Cites Piramal Pharma for Inves

Piramal Pharma’s API unit at Navi Mumbai was issued USFDA Form 483 with six observations

Sun Pharma Dadra USFDA 483 cites Lack of

Sun Pharma Dadra unit was inspected by USFDA in December 2023 by FDA investigator Pratik

FDA Issues guidance for Handling and Ret

FDA has issued a new guidance for handling reserve samples from bioavailability (BA) and bioequivalence

USFDA483 to Aurobindo’s Eugia US Site

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