FDA Inspection 1028586 — DJO, LLC
The FDA completed an inspection of DJO, LLC on September 26, 2017 in Vista, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 26, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Vista, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |