FDA 483 - Ideal Implant Incorporated - February 03, 2020

Ideal Implant Incorporated, a medical device manufacturer in Dallas, TX, was inspected by the FDA from January 27 to February 3, 2020. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for complaint handling, untimely submission of Medical Device Reports (MDRs), and ineffective corrective and preventive actions. Additionally, the firm's finished device acceptance procedures were insufficient, risk analysis was incomplete, and software used in the quality system was not validated.