FDA Inspection 1289318 — Supreme Screw Products, Inc.
The FDA completed an inspection of Supreme Screw Products, Inc. on Oct 29, 2025 in Plainview, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 29, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Plainview, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |