FDA Inspection 1032209 — Temrex Corporation
The FDA completed an inspection of Temrex Corporation on November 21, 2017 in Freeport, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 21, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Freeport, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |