FDA Inspection 1200062 — USA Facemask LLC
The FDA completed an inspection of USA Facemask LLC on March 17, 2023 in Pineville, NC. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 17, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Pineville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |