FDA WARNING_LETTER - Orchid Orthopedic Solutions, LLC - February 15, 2019

The FDA conducted an inspection of Orchid Orthopedic Solutions, LLC, a medical device manufacturer specializing in coatings for orthopedic implants, from February 4 to February 15, 2019. The inspection revealed that the firm's devices are adulterated under section 501(h) of the Act, 21 U.S.C. § 351(h), because manufacturing methods, facilities, or controls do not conform to the Quality System regulation (21 CFR Part 820). The firm's March 11, 2019, response to the FDA-483 was largely deemed inadequate or unassessable due to missing documentation. Key violations include: failure to establish and maintain procedures for controlling nonconforming product (21 CFR 820.90(a)), monitoring validated process parameters (21 CFR 820.75(b)), and implementing corrective and preventative actions (21 CFR 820.100(a)). Additionally, the firm failed to adequately validate a process (21 CFR 820.75(a)), establish timely complaint handling procedures (21 CFR 820.198(a)), and adequately establish quality audit procedures (21 CFR 820.22). The FDA requires the firm to provide a written response within fifteen business days detailing specific corrective actions, prevention plans, and documentation. Failure to promptly correct these systemic violations may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts, premarket approvals, and Certificates to Foreign Governments.