FDA Inspection 634596 — Advanced Orthodontics Systems Inc.
The FDA completed an inspection of Advanced Orthodontics Systems Inc. on Nov 18, 2009 in Valley Stream, NY. 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
- Nov 18, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Valley Stream, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 636 | 21 CFR 803.17(b)(2) | Reports and information documentation |