FDA 483 - Micro Precision Swiss, LLC - September 12, 2024

Micro Precision Swiss, LLC, a medical device manufacturer in Santa Ana, CA, was cited for two observations during an FDA inspection. The firm failed to adequately establish and implement procedures for corrective and preventive actions, leading to ineffective CAPAs and unaddressed deficiencies. Additionally, procedures for the acceptance of in-process product were not adequately established, resulting in out-of-specification dimensions and customer complaints.