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FDA Begins cGMP Reinspection Of Teligent’s Key Facility

US Firm’s Buena Site Received Warning Letter Late In 2019

 
• By Akriti Seth

Teligent is relying upon the FDA approval of its manufacturing capacity at Buena, New Jersey to reintroduce its products in the market and “significantly expand” its production capabilities within the sterile injectables segment. 

facility inspection
Teligent unsure of when the FDA will provide results of the inspection and reinspection of its Buena, New Jersey manufacturing facility • Source: Alamy

Teligent, Inc. has revealed that the US Food and Drug Administration has commenced an “earlier than anticipated” current good manufacturing practices inspection and reinspection of the company’s key manufacturing facility in Buena New Jersey, to follow up on warning letter remediation action that was initiated in mid-July. 

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