USFDA Concludes Pre Approval Inspection at Enzene Biosciences Unit
New Delhi, February 16: Alkem Laboratories on Monday said the United States health regulator has issued a Form 483 with six observations following an inspection of the manufacturing facility of its wholly owned subsidiary Enzene...
alkem laboratories
bse
chakan
data integrity
drug firm
enzene biosciences
fd&c act
form 483
india
manufacturing unit
pharmaceutical industry
pharmaceutical manufacturing
qualitysystems
regulatory inspection
us food and drug administration (usfda)
