FDA Inspection 1112502 — MiMedx Group, Inc.
The FDA completed an inspection of MiMedx Group, Inc. on December 12, 2019 in Marietta, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 12, 2019
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Marietta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 6705 | 21 CFR 310.305(c) | Failure to submit ADE report |