FDA Inspection 801849 — Digitimer Ltd.
The FDA completed an inspection of Digitimer Ltd. on Aug 30, 2012 in Welwyn Garden City. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 30, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Welwyn Garden City (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 3241 | 21 CFR 820.72(b)(1) | Calibration standard traceability |
| 3696 | 21 CFR 820.100(b) | Documentation |