FDA Inspection 584280 — Tetracore, Inc.
The FDA completed an inspection of Tetracore, Inc. on May 28, 2009 in Rockville, MD. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 28, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rockville, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2429 | 21 CFR 820.30(b) | Establish the design and development plan |
| 2628 | 21 CFR 820.30(e) | Design review procedures - personnel |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |