FDA Inspection 1111969 — Tetracore, Inc.
The FDA completed an inspection of Tetracore, Inc. on December 6, 2019 in Rockville, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 6, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rockville, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3113 | 21 CFR 820.70(g) | Equipment design and installation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |