FDA Inspection 713530 — Perma Pure LLC
The FDA completed an inspection of Perma Pure LLC on March 18, 2011 in Lakewood, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 18, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lakewood, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |