483
Theragen, IncFDA 483 - Theragen, Inc - February 20, 2020
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Record Details
An FDA inspection of Theragen, Inc, a medical device manufacturer in Manassas, VA, identified one observation related to inadequate documentation of corrective and preventive action (CAPA) activities. Specifically, a CAPA remained open despite a verification effectiveness check being completed. This indicates a deficiency in the firm's quality system regarding CAPA management.
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ID · f590c976-2366-47c8-bf64-0101404bb74f