A Form-483 observation letter was issued by the USFDA post the inspection, listing 11 observations.
New Delhi: Drug major Sun Pharmaceutical Industries has received 11 observations from the US health regulator after inspection of its Dadra facility.
The company’s Dadra facility underwent an inspection by United States Food and Drug Administration (USFDA) recently. This inspection was completed on April 13, 2017, Sun Pharmaceutical Industries said in a BSE filing on Saturday.
“A Form-483 observation letter was issued by the USFDA post the inspection, listing 11 observations,” it added.
The company, however, did not provide any details about the observations made by the US health regulator.
As per USFDA, a FDA Form 483 is issued to firm 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”.
It notifies the company’s management of objectionable conditions at the facility.
“We are currently in the process of responding to the said letter to USFDA within the stipulated timeline of 15 days”, Sun Pharmaceutical Industries said.
However, Sun Pharma said the company and its subsidiaries have many facilities which supply products to the US market. These facilities undergo periodic routine inspection by the USFDA in normal course of business.