The unit is situated at Raleigh, North Carolina and was inspected from August 22 to August 26, 2022.
“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. We will respond to the USFDA within the stipulated timeline and work closely with the USFDA to address the observation at the earliest,” the company said in a regulatory filing.
Following the development, the stock fell 3.23 per cent to hit a low of Rs 532.10 on BSE.
The US unit manufactures MDI (Metered Dose Inhalers) and derma products. The unit has filed two Derma products and one MDI product.