FDA Inspection 1177708 — Midlab Incorporated
The FDA completed an inspection of Midlab Incorporated on August 5, 2022 in Athens, TN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 5, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Athens, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |