483
Cognita Labs LLCFDA 483 - Cognita Labs LLC - December 13, 2023
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Cognita Labs LLC, a medical device manufacturer in Santa Ana, CA, was inspected by the FDA from December 7-13, 2023. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning the establishment of adequate procedures for device history records and the disposition of nonconforming products. These issues indicate a lack of proper documentation and control over manufacturing processes and product quality.
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ID · a19a472e-3fbf-4df3-8279-48d33fbfc09a