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…
Latest Form 483 News & Updates
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…