FDA Inspection 958844 — MiMedx Group, Inc.
The FDA completed an inspection of MiMedx Group, Inc. on February 4, 2016 in Marietta, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 4, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Marietta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12401 | 21 CFR 1271.230(b) | Reduced risk representation |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4354 | 21 CFR 211.165(d) | Acceptance/Rejection Levels |
| 4379 | 21 CFR 211.188(b)(1) | Dates not included for each significant step |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |