Last Updated on December 31, 2023 by The Health Master
Aurobindo Pharma said the US health regulator has issued one observation after inspecting a plant owned by its US-based unit.
The US Food and Drug Administration (USFDA) conducted its Pre-Approval Inspection (PAl) and GMP (Good Manufacturing Practice) inspection from August 22-26 at the Raleigh-based plant, which has been set up for manufacturing MOl (Metered Dose Inhalers) and derma products, the Hyderabad-based drug firm said in a regulatory filing.
The plant is owned by Aurolife Pharma LLC, a wholly-owned step-down subsidiary of the company, it added.
“At the end of the inspection, Aurolife has been issued a ‘Form 483’ with one observation, and the observation is procedural in nature, and there are no data integrity issues,” Aurobindo Pharma said.
The company will respond to the USFDA within the stipulated timeline, it added.
As per USFDA, Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator has observed any conditions that, in its judgment, may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and related Acts.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
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