FDA Inspection 652628 — Arch - MedTorque Inc.
The FDA completed an inspection of Arch - MedTorque Inc. on Mar 18, 2010 in Kenosha, WI. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 18, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kenosha, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3667 | 21 CFR 820.20(c) | Management review accomplishment |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4189 | 21 CFR 820.198(a) | General |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |