By: IPP Bureau
Last updated : August 29, 2022 10:14 pm
The unit has filed 2 Derma products and 1 MDI product.
The United States Food and Drug Administration (US FDA) conducted its pre-approval inspection (PAI) and GMP inspection from August 22 to August 26, 2022, of Aurolife Pharma LLC's Unit at Raleigh, North Carolina, USA, established for manufacturing MDI (Metered Dose Inhalers) and Derma products.
The unit has filed 2 Derma products and 1 MDI product.
At the end of the inspection, Aurolife has been issued a 'Form 483' with 1 observation and the observation is procedural in nature and there are no data integrity issues. We will respond to the US FDA within the stipulated timeline and work closely with US FDA to address the observation at the earliest.