FDA Inspection 552069 — Mie Medical Research Limited
The FDA completed an inspection of Mie Medical Research Limited on Nov 26, 2008 in Leeds. 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
- Nov 26, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Leeds (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 3332 | 21 CFR 820.184(e) | ID label, labeling |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |