FDA WARNING_LETTER - Vilex in Tennessee, Inc. - August 25, 2017

On January 9, 2018, the FDA issued a Warning Letter to Vilex in Tennessee, Inc., following an inspection from August 16-25, 2017. The firm, a specification developer, relabeler/repacker, and limited manufacturer of Class I and Class II orthopedic implants and tools, was found to have adulterated devices due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish design history files (21 CFR 820.30(j))**: Specifically for eight Class II devices (e.g., Met-Head Implant, Vilex Bone Plate System). The firm's response was inadequate, lacking specifics on existing documentation and failing to confirm completion of DHF compilation by stated deadlines. 2. **Failure to adequately establish procedures for design validation (21 CFR 820.30(g))**: Design validation activities for the Orthex External Fixation System were completed two years before the validation protocol was approved. Validation results lacked required identification details and contained product code misidentifications. The firm's response was inadequate, lacking updated procedures, training evidence, or results of DHF reviews. 3. **Failure to adequately establish procedures for purchasing (21 CFR 820.50)**: The Purchasing Procedure (QSP