U.S. FDA issues four observations to Piramal Pharma’s facility near Hyderabad

The U.S. Food and Drug Administration (U.S. FDA) has issued four observations to Piramal Pharma’s facility in Digwal, near Hyderabad.

The regulator had conducted a general good manufacturing practices (GMP) inspection of the facility from February 9-13 and on conclusion issued a Form-483 with four observations, the company said in a filing on Saturday.

They are related to enhancement in procedures and not related to data integrity. A detailed response to the observations will be submitted to the U.S. FDA within the stipulated timelines, Piramal Pharma said.

GPCB directions on Dahej unit

In another filing, the company said Gujarat Pollution Control Board, which earlier this month ordered closure of its Dahej facility citing violation of Section 33A of the Water (Prevention and Control of Pollution) Act, 1974, has granted an interim revocation of the closure directions.

Consequently, the company is authorised to resume operations at the Dahej site with immediate effect. The company is committed to working on measures with the GPCB to ensure that the interim directions are made final in due course, Piramal Pharma said.