FDA WARNING_LETTER - Troy Innovative Instruments Inc - June 30, 2015

During an FDA inspection from June 5-30, 2015, Troy Innovative Instruments Inc., a contract manufacturer of orthopedic devices, was found to be in violation of Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). The devices were deemed adulterated under section 501(h) of the Act.

Key violations include: 1. **Failure to validate processes (21 CFR § 820.75(a)):** This includes laser etching (no post-processing metal fatigue testing), Nitric passivation (no worst-case load size testing), TIG welding (no strength testing or post-heat treat tensile strength data), tumbling (not validated, potential for burs/edge removal), electropolishing (no worst-case scenario testing), and manual/sonic cleaning (no evidence of required supplemental lighting/borescope). 2. **Failure to document adverse effects from rework (21 CFR § 820.90(b)(2)):** No testing or analysis was conducted to show that re-processed nonconforming products (e.g., re-passivation, re-cleaning) were not adversely affected. 3. **Failure to control nonconforming product (21 CFR § 820.90(a)):** Scrap parts were not accurately accounted for on manufacturing workstations, and not