USFDA's Inspection At FDCs Manufacturing Facility In Raigad Completed With 'No Action Indicated'

USFDA's Inspection At FDCs Manufacturing Facility In Raigad Completed With 'No Action Indicated'

The inspection has concluded and a copy of the narrative portion of the Establishment Inspection Report has been issued.

FPJ Web DeskUpdated: Thursday, June 15, 2023, 02:34 PM IST
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USFDA's Inspection At FDCs Manufacturing Facility In Raigad Completed With 'No Action Indicated' | Image: FDC Limited (Representative)

U.S. Food and Drug Administration (USFDA) completed an inspection at the company's manufacturing facility in Roha, Raigad with the classification as ‘no action indicated', the company announced through an exchange filing. Based on the inspection the facility is considered to be in an acceptable state of compliance with regards to current good manufacturing practice.

The inspection by the USFDA was conducted between March 20 and March 24, 2023. The inspection has concluded and a copy of the narrative portion of the Establishment Inspection Report has been issued.

The Active Pharmaceutical Ingredients (API’s) product manufactured at the above facility continues to be marketed in the USA.

USFDA conducts audit at Aurangabad facility

USFDA in February had conducted an audit at FDC's Aurangabad manufacturing facility and closed it with no observations.

FDC Shares

The shares of FDC Limited on Thursday at 2:27 pm IST were at Rs 307.15, down by 0.60 per cent.

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