FDA Inspection 1198732 — MiMedx Group, Inc.
The FDA completed an inspection of MiMedx Group, Inc. on March 2, 2023 in Kennesaw, GA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 2, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Kennesaw, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 21297 | 21 CFR 211.186(a) | Master production and control records, procedure |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |