USFDA issues an EIR for Ipca Laboratories' Pithampur plant

31 Oct 2023 , 12:23 PM

During its examination of Ipca Labs’ facilities in Pithampur and Indore, the US Food and Drug Administration (USFDA) discovered eight problems. The FDA has also sent Form 483 to the corporation after discovering issues with its facilities in several locations. 

Between June 15 and June 23, the USFDA conducted an examination and discovered issues with the company’s Pithampur, Indore, and Ratlam facilities.

It was tested at the Pithampur production site of the business that makes its formulations, and Form 483 was issued upon discovering 8 objections. 

When the Ratlam API plant was investigated from June 5 to June 13, the American regulatory authorities also discovered 11 objections.

The Ratlam and Pithampur locations of Ipca Labs are subject to an import notice following the FDA probe.

The US regulatory agency stated that the business must address the concerns the FDA brought up on Form 483.

It went on to say that in order for the Ratlam and Pithampur plants to revive in the US generics business, clean chit is required.

The FDA discovered several notable complaints, including the company’s inability to meet quality standards for the API batch, inconsistent processing conditions that raise serious concerns about quality, and ineffective record-keeping.

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