FDA Inspection 735208 — DJO, LLC
The FDA completed an inspection of DJO, LLC on July 14, 2011 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
- July 14, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Vista, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3237 | 21 CFR 820.72(b) | Remedial action |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 812 | 21 CFR 803.56 | Submission of Supplement to Individual Report Within One Month |