FDA Inspection 922197 — Allesee Orthodontic Applicances, Inc.
The FDA completed an inspection of Allesee Orthodontic Applicances, Inc. on April 10, 2015 in Enfield, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 10, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Enfield, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |