FDA 483 - National Medical Products Inc - May 30, 2024

An FDA inspection of National Medical Products Inc, a medical device manufacturer in Irvine, CA, identified one significant observation. The firm's procedures for corrective and preventive actions (CAPA) were found to be inadequate, specifically lacking requirements for verifying or validating the effectiveness of CAPAs and ensuring they do not adversely affect finished devices. This indicates a deficiency in their quality system regarding post-market controls.