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 Form 483 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,”…
New Delhi, April 18 (IANS) Major drug maker Lupin on Saturday said that the US health regulator has issued a ‘Form 483’ with three observations to its manufacturing facility in Somerset, New Jersey, following a recent inspection.In a regulatory filing, the pharmaceutical company said that the inspection by the US Food and Drug Administration (USFDA) was conducted this week between April 13 and April 17.”The inspection was completed with the issuance of a Form 483 carrying three observations,” th…
New Delhi, March 17 (IANS) Aurobindo Pharma on Tuesday said that the US Food and Drug Administration (USFDA) has classified one of its subsidiary units as “Official Action Indicated” (OAI) following an inspection conducted last year.In a regulatory filing, the company said that the USFDA inspected Unit-II of Eugia Pharma Specialities Limited, its wholly-owned subsidiary, located in Bhiwadi, Rajasthan, between November 3 and 14, 2025.At the end of the inspection, the regulator had issued a Fo…