Sun Pharma perspires: cracks 5 % on USFDA's letter

India’s largest drug major, Sun Pharma has cracked down by close to 5 per cent in early trade owing to a report from IIFL, which said that the regulator has issued a 14-page 483 observation letter after inspecting its Halol unit.

Brokerage house, IIFL said that the US FDA has issued a 14-page 483 observation letter after the inspection carried out in company’s Halol unit in Gujarat on December 1.

However, the content of the letter is not available yet and is likely to be out in few days’ time.

An FDA Form 483 is issued to a firm's management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously.

Fall in the shares can also be attributed to investors' concerns over the company’s important facility which garners large revenue from the US markets.

Investors are advised to let the official disclosure of the letters be made public before taking any further investment decision.