USFDA concludes inspection of Indoco’s Sterile facility (Plant II)

The US health regulator made four observations on the pharma company’s Goa plant

The US Food and Drug Administration (US FDA) conducted an audit at Indoco’s sterile manufacturing facility in Verna, Goa (Plant II) from 27th May’19 to 4th June’19. According to a press release issued by the company, the US health regulator made four observations (483s).

“These observations are procedural in nature, not pertaining to data integrity. The company will submit its responses shortly,” stated the press release.

Commenting on this development, Aditi Kare Panandikar, Managing Director – Indoco Remedies, stated, “The recent USFDA inspection was a scheduled Prior Approval Inspection (PAI) for Injectable products, filed from this facility. We are hopeful for an early and successful closure of this audit, which will expedite approvals of the pending ANDAs.”