USFDA completes Nalagarh facility inspection: Wockhardt

Drug firm Wockhardt, which has been under the USFDA scanner, Thursday said that United States health regulator has completed inspection of its Nalagarh facility in Himachal Pradesh.

New Delhi: Drug firm Wockhardt, which has been under the USFDA scanner, Thursday said that United States health regulator has completed inspection of its Nalagarh facility in Himachal Pradesh.

"The inspection of the company's manufacturing unit at ...Nalagarh, District Solan, Himachal Pradesh by United States Food and Drug Administration (USFDA) has since been completed," Wockhardt said in a filing to the BSE.

No Form 483 has been issued by US FDA in this regard, it added.

As per the USFDA, "an 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".

The FDA Form 483 notifies the company's management of objectionable conditions.
Wockhardt stock closed at Rs 1,502.50, down 1.87 percent, on the BSE.

By continuing to use the site, you agree to the use of cookies. You can find out more by clicking this link

Close