US FDA issues Form 483 with 10 observations to Sun Pharma’s Halol unit

Listed multinational pharmaceutical entity Sun Pharmaceutical Industries on Tuesday informed the exchanges that the US FDA has issued Form 483 with ten observations to the company’s Halol unit.

The US FDA (United States Food and Drug Administration) had conducted a Good Manufacturing Practices (GMP) inspection of the company’s Halol facility in Gujarat between April 26 and May 9, 2022.

“The Company is preparing the response to the observations, which will be submitted to the US FDA within 15 business days. The Company is committed to addressing these observations promptly,” the company said in a press release.


The stock traded with cuts of over 3% as of 11:45 am while the benchmark indices were trading flat with a positive bias.