# FDA WARNING_LETTER - Z-Medica, LLC - November 03, 2009

Source: https://www.keypedia.com/records/warning_letter/z-medica-llc/4300f3e5-c280-4045-b085-1a97f1e53feb

> FDA WARNING_LETTER for Z-Medica, LLC on November 03, 2009. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Z-Medica, LLC
- Inspection Date: 2009-11-03
- Product Type: Devices
- Office Name: New England District Office
- Summary: On December 3, 2009, the FDA issued a Warning Letter to Z-Medica Corporation following an inspection from October 26-28 and November 3, 2009. The inspection revealed that Z-Medica's medical devices, including QuikClot Combat Gauze, were adulterated under 21 U.S.C. 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 C.F.R. Part 820).

Violations included:
1.  **Failure to fully validate and approve according to established procedures (21 CFR 820.75(a))**: The sterilization validation procedure for QuikClot Combat Gauze did not meet ISO 11137-2:2006 Part 2 requirements for using multiple product lots, and dosimeters/biological indicators were not placed in routine production runs for gamma sterilization. Z-Medica's proposed re-validation with three lots by December 31, 2009, was acknowledged, but data was requested.
2.  **Failure to establish and maintain procedures for monitoring and control of process parameters (21 CFR 820.75(b))**: The sealing machine process validation lacked documentation for periodic burst testing. A change from burst to

## Related Officers

- [John R. Marzilli](https://www.keypedia.com/people/john-r-marzilli/0422092e-bccc-4c8d-91cb-17f4263a8851)

Company: https://www.keypedia.com/companies/z-medica-llc/cad7ff68-be9a-483c-b810-d6468325f5c4

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144