FDA Inspection 1005671 — MTI Precision Products LLC.
The FDA completed an inspection of MTI Precision Products LLC. on March 16, 2017 in Coatesville, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 16, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Coatesville, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |