# FDA WARNING_LETTER - MedX Corporation - August 16, 2007

Source: https://www.keypedia.com/records/warning_letter/medx-corporation/ee948557-2409-4fb1-84b5-a5067507f161

> FDA WARNING_LETTER for MedX Corporation on August 16, 2007. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: MedX Corporation
- Inspection Date: 2007-08-16
- Product Type: Devices
- Office Name: Florida District Office
- Summary: 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

## Related Officers

- [David Fleming](https://www.keypedia.com/people/david-fleming/3de22135-b4f4-4d44-88e6-478054754d5a)
- [District Director](https://www.keypedia.com/people/emma-r-singleton/e0b72aba-caa5-4cf8-8beb-6f93f6654e59)

Company: https://www.keypedia.com/companies/medx-corporation/6314cc08-6684-48af-a572-8339a9d3f87d

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9