FDA Inspection 1250925 — United Health Products, Inc.
The FDA completed an inspection of United Health Products, Inc. on Oct 4, 2024 in Mount Laurel, NJ. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 4, 2024
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Mount Laurel, NJ (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14511 | 21 CFR 812.2(b) | Abbreviated requirements / non-significant risk study |
| 2910 | 21 CFR 812.7(a) | Promotion or test marketing |
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2952 | 21 CFR 812.46(b)(1) | No evaluation of unanticipated adverse effects |
| 2993 | 21 CFR 812.140(b)(2) | Sponsor device disposition records inadequate |
| 3003 | 21 CFR 812.140(b)(6) | Other sponsor records required by FDA inadequate |
| 6849 | 21 CFR 812.5(a) | Label does not contain required information |