New Delhi, May 16 (IANS) Emcure Pharmaceuticals on Saturday said the United States Food and Drug Administration (US FDA) completed a current Good Manufacturing Practices (cGMP) inspection at its formulations manufacturing facility in Sanand, Ahmedabad, Gujarat, and issued a Form 483 with seven observations.The inspection was conducted between May 6 and May 15, 2026, at the company’s facility located in the G.I.D.C. industrial area in Taluka-Sanand, Ahmedabad. According to the company, the obse…
Latest United States Food and Drug Administration 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,”…
