FDA Inspection 602295 — Phoenix Diagnostics, Inc.
The FDA completed an inspection of Phoenix Diagnostics, Inc. on August 6, 2009 in Natick, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 6, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Natick, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |