FDA Inspection 937709 — MicroPort Orthopedics Inc.
The FDA completed an inspection of MicroPort Orthopedics Inc. on Aug 19, 2015 in Arlington, TN. 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
- Aug 19, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Arlington, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14719 | 21 CFR 820.30(h) | Incorrect translation to production specifications |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |