FDA Inspection 871900 — 3M Unitek Corporation
The FDA completed an inspection of 3M Unitek Corporation on Mar 27, 2014 in Monrovia, CA. 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). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 27, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Monrovia, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3237 | 21 CFR 820.72(b) | Remedial action |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |