FDA Inspection 1162762 — PARAFFIN USA LLC
The FDA completed an inspection of PARAFFIN USA LLC on Feb 22, 2022 in Phoenix, AZ. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 22, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Phoenix, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3264 | 21 CFR 820.250(b) | Sampling methods - Lack of or inadequate procedures |
| 3343 | 21 CFR 820.198(e) | Maintained |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |