FDA Inspection 1211404 — InVitroCare, Inc
The FDA completed an inspection of InVitroCare, Inc on August 3, 2023 in Frederick, MD. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 3, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Frederick, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |