FDA WARNING_LETTER - Prismatik Dentalcraft, Inc. - July 26, 2013

FDA inspected Prismatik Dentalcraft, Inc. (Irvine, CA) from June 26 to July 26, 2013, regarding their Prismatik dental implants and abutment systems. The inspection found the devices adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) and § 352(o). Key QS violations included failure to establish design change procedures (e.g., unvalidated screw substitutions), inadequate corrective and preventive action (CAPA) procedures, incomplete complaint investigation records, undocumented design review results, and insufficient management reviews of the quality system. Additionally, the firm failed to report device malfunctions (broken screws) within 30 days as required by 21 CFR Part 803 and maintained inadequate written MDR procedures. Furthermore, Prismatik Dentalcraft was marketing Inclusive brand screws without 510(k) clearance, making them adulterated and misbranded. The FDA requires a written response within fifteen business days detailing specific corrections, preventive actions, and a timetable. Failure to comply may result in severe regulatory actions, including seizure, injunction, civil money penalties, and impact on federal contracts, PMA approvals, and Certificates to Foreign Governments, indicating systemic quality management issues.