FDA Inspection 1275951 — Custom Wire Technologies, Inc.
The FDA completed an inspection of Custom Wire Technologies, Inc. on Jul 17, 2025 in Port Washington, WI. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 17, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Port Washington, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3270 | 21 CFR 820.80(c) | Documentation |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |