FDA Inspection 770926 — Haag Streit U.K. Limited
The FDA completed an inspection of Haag Streit U.K. Limited on Mar 1, 2012 in Harlow. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 1, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Harlow (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3837 | 21 CFR 820.25(b) | Training records |