FDA WARNING_LETTER - Conformis Inc. - November 15, 2019

The FDA issued a Warning Letter to a manufacturer of Class II sterile orthopedic implants, including iTotal Knee and Hip Replacement Systems, following an inspection from September 16-20 and November 14-15, 2019. The inspection revealed that the devices are adulterated under 21 U.S.C. § 351(h) because manufacturing, packing, storage, or installation methods and controls do not conform to the Quality System regulation (21 CFR Part 820).

A key violation identified was the failure to establish and maintain procedures for corrective and preventive actions (CAPA), specifically regarding recurring nonconforming product issues with Class II Knee Implants, as required by 21 CFR Part 820.100(a)(3). Despite CAPA 18-032 initiated in October 2018 to address recurring issues with (b)(4) through supplier preventative maintenance and repair, the problem persisted as recently as June 2019. The firm's proposed long-term solution involves replacing the (b)(4) pending 510(k) approval (K193105 submitted November 6, 2019). However, the FDA noted that the firm continues to rely on (b)(4) for sterility assurance without ensuring the process is validated, lacking objective evidence that the (b)(4) are operating in a