FDA Inspection 821760 — Hooper Holmes, Inc.
The FDA completed an inspection of Hooper Holmes, Inc. on March 7, 2013 in Olathe, KS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 7, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Olathe, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3239 | 21 CFR 820.72(b) | Remedial action - documentation |
| 3837 | 21 CFR 820.25(b) | Training records |