OsteoSymbionics LLC – FDA Warning Letter, Nov 3, 2010

During an FDA inspection from October 13 to November 3, 2010, OsteoSymbionics, LLC, a manufacturer of cranial plate implants, was found to be in violation of Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation (21 CFR Part 820). The devices were deemed adulterated under section 501(h) of the Act.

Key violations include: 1. **Failure to control device design (21 CFR 820.30(a))**: Inadequate design controls for cranial plate implants distributed since 2008, specifically lacking a design and development plan (820.30(b)), established design inputs (820.30(c)), proper implementation of design verification procedures (820.30(f)) (e.g., missing "Summation of the test outcome" for six of eight tests), and validation of the cranial implant design (820.30(g)). 2. **Failure to validate processes (21 CFR 820.75(a))**: Unvalidated mixing, curing, casting, and cleaning processes. Sterilization validation did not include multiple cycles despite instructions for re-sterilization, and only validated 55% relative humidity, not the full 30-80% range specified in instructions. 3. **Failure to establish