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