FDA made 9 observations post Halol unit inspection: Sun Pharma

Sun Pharmaceutical Industries today said that the US health regulator has made nine observations after the completion of inspection of its Halol facility in Gujarat.

The United States Food and Drug Administration (USFDA) had inspected the Halol facility from November 17, 2016 through December 1, 2016, Sun Pharma said in a BSE filing.

“At the conclusion of the inspection, USFDA issued Form 483, citing nine inspectional observations. None of those observations were characterised by USFDA as repeat observations,” it added.

However, the company did not disclose the observations made by USFDA.

The company is preparing responses to the observations, which will be submitted to USFDA within 15 business days of receipt of the Form 483, Sun Pharma said.

“The company intends to implement promptly any corrective actions and improvements that may be necessary as a result of the observations and to continue to work cooperatively with USFDA,” Sun Pharma said.

Sun Pharma had been earlier issued a warning letter by USFDA for its Halol facility in December 2015. The letter followed inspection of the facility in September 2014 by FDA inspectors.

The company has been making efforts to make the Halol plant CGMP-compliant again.

As per the USFDA, observations are made in Form 483 when investigators feel that conditions or practices in the facility are such that products may become adulterated or render injuries to health.

The FDA Form 483 notifies the company’s management of objectionable conditions.

Shares of Sun Pharmaceutical Industries ended the session up by 1.75 per cent at Rs 675.55 on the BSE.

COMMENT NOW