FDA Inspection 768317 — Pro-Paks, LLC
The FDA completed an inspection of Pro-Paks, LLC on February 3, 2012 in Middletown, 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
- February 3, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Middletown, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |