New Delhi, February 16 Alkem Laboratories said on Monday that the US health regulator has issued a Form 483 with six observations after inspecting the manufacturing unit of its wholly-owned subsidiary, located in Chakan.The US Food and Drug Administration (USFDA) completed a pre-approval...
alkem laboratories
bse
chakan
data integrity
drug firm
enzene biosciences
fd&c act
form 483
india
manufacturing unit
pharmaceutical industry
pharmaceutical manufacturing
quality systems
regulatory inspection
us food and drug administration (usfda)