FDA Inspection 814255 — Hamilton Thorne, Inc
The FDA completed an inspection of Hamilton Thorne, Inc on Jan 10, 2013 in Beverly, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 10, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Beverly, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 5007 | 21 CFR 1002.13 | Failure to submit |