Latest Good Manufacturing Practice News & Updates

New Delhi, May 3 (IANS) Pharmaceutical major Alkem Laboratories has come under regulatory scrutiny after the United States Food and Drug Administration (USFDA) issued inspectional observations at its manufacturing facility in Amaliya, Daman, following a recent audit.The inspection, conducted over 12 days from April 20 to May 1, concluded with the issuance of a Form 483, in which the US regulator flagged seven observations.A Form 483, formally known as a “Notice of Inspectional Observations,”…