FDA Inspection 594561 — Diamond Diagnostics, Inc.
The FDA completed an inspection of Diamond Diagnostics, Inc. on July 2, 2009 in Holliston, 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
- July 2, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Holliston, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3239 | 21 CFR 820.72(b) | Remedial action - documentation |
| 3416 | 21 CFR 820.70(a)(1) | Process control instructions |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |