FDA Inspection 660150 — Advanced OrthoPro, Inc.
The FDA completed an inspection of Advanced OrthoPro, Inc. on Apr 29, 2010 in Indianapolis, IN. 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
- Apr 29, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3149 | 21 CFR 820.180 | Availability |
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |