FDA Inspection 1236757 — Technicuff Corp.
The FDA completed an inspection of Technicuff Corp. on April 24, 2024 in Leesburg, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 24, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Leesburg, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |