FDA Inspection 827533 — Astute Choice Packaging
The FDA completed an inspection of Astute Choice Packaging on April 12, 2013 in Henrico, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 12, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Henrico, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 3309 | 21 CFR 820.120(b) | Examination for accuracy |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3668 | 21 CFR 820.20(c) | Management review dates |