FDA Inspection 897335 — Ossur Americas
The FDA completed an inspection of Ossur Americas on Aug 21, 2014 in Foothill Ranch, 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 21, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Foothill Ranch, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 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 |