Sun Pharma’s Halol plant gets Form 483 with 10 observations from the USFDA

The Sun Pharma’s Halol facility was classified as ‘Official Action Indicated (OAI)’ in March 2020, and was awaiting re-inspection from the US regulator USFDA.

The USFDA has issued a Form 483 with 10 observations after inspection of Sun Pharma’s Halol facility, the company said. Halol facility, however, at present has a very low contribution to the company’s turnover.

The Halol facility was classified as ‘Official Action Indicated (OAI)’ in March 2020, and was awaiting re-inspection from the US regulator. Due to the coronavirus (Covid-19) pandemic related travel restrictions, the re-inspection got delayed, and now the USFDA has issued Form 483 with observations, which is an improvement over the OAI status.

In a notification to the stock exchanges, Sun Pharma said that the US Food and Drugs Administration (USFDA) did a…read more