MedX Corporation – FDA Warning Letter, Aug 16, 2007

On February 4, 2008, the FDA issued a Warning Letter to MedX Corporation following an inspection from August 8-16, 2007, at their Ocala, FL facility. The inspection revealed that MedX's lumbar (K880032) and cervical extension (K896533) devices, classified as medical devices, were adulterated under 21 U.S.C. 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System Regulation (QSR), 21 CFR Part 820.

Key violations included: 1. **Software Validation (21 CFR 820.30(g))**: Failure to adequately validate device software (e.g., [redacted] Software versions) and perform comprehensive risk analysis, a recurring issue since 1995. MedX's response was deemed inadequate due to missing documentation. 2. **Design Input Procedures (21 CFR 820.30(c))**: Failure to establish adequate procedures for design inputs, leading to ambiguous requirements for the [redacted] Software. Response was inadequate due to missing documentation. 3. **Design Verification (21 CFR 820.30(f))**: Failure to ensure design verification confirmed design output met input requirements, specifically for