FDA WARNING_LETTER - Ortho-Cycle Company Inc. - March 13, 2013

On May 16, 2013, the FDA issued a Warning Letter to Ortho-Cycle Company Inc. following a March 11-13, 2013 inspection. The firm, a reprocessor of single-use metal and ceramic dental brackets, was found to have adulterated devices under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded devices under 21 U.S.C. § 352(t)(2) for failing to comply with Medical Device Reporting (MDR) regulations (21 CFR Part 803).

Key violations include: 1. **Process Validation (21 CFR 820.75(a)):** Failure to validate or adequately document validation for reprocessing steps of ceramic brackets, gold-plated brackets, expansion screws, and specific processes for metal dental brackets (e.g., (b)(4) process, (b)(4) Removing and Shining of Metal Attachments (b)(4)). The firm's response was inadequate, lacking complete corrective actions and systemic review. 2. **Complaint Handling (21 CFR 820.198(a)):** Inadequate procedures for receiving, reviewing, and evaluating complaints, including lack of requirements for investigations when no product is