Sun Pharma's Halol unit gets 10 observations under USFDA's Form 483

Plant's OAI status is unchanged, hinting at status quo; Sun Pharma says will respond to observations within 15 days

The USFDA has issued a form 483 with 10 observations after inspection of Sun Pharma's Halol facility, the company said. The unit, however, now has a low contribution to the company’s turnover.

The Halol facility was classified ‘Official Action Indicated (OAI)’ in March 2020, and was awaiting re-inspection from the US regulator. Due to the pandemic related travel restrictions, the re-inspection got delayed, and now the USFDA has issued a form 483 with observations.

In a notification to the stock exchanges, Sun Pharma said that the US Food and Drugs Administration (USFDA) did a Good Manufacturing Practices (GMP) inspection of