FDA 483 - Westridge Laboratories Inc - December 29, 2025
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An FDA inspection of Westridge Laboratories Inc. in Santa Ana, CA, revealed significant deficiencies in their quality system for medical devices. Observations included inadequate corrective and preventive action procedures, failure to apply Unique Device Identifiers (UDI) on product labels, and incomplete information in the Global Unique Device Identification Database (GUDID). Additionally, the firm's design input procedures were found to be inadequately established.
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