Aurobindo Pharma yesterday 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 (FDA) conducted its Pre-Approval Inspection (PAl) and Good Manufacturing Practice (GMP) inspection from 22nd to 26th August, 2022 of Raleigh-based plant which has been set up for manufacturing Metered Dose Inhalers (MDIs) and derma products, the Hyderabad-based drug firm said in a regulatory filing.
The plant is owned by Aurolife Pharma, 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 FDA within the stipulated timeline, it added.
Edits by EP News Bureau