FDA Inspection 794812 — Temrex Corporation
The FDA completed an inspection of Temrex Corporation on August 7, 2012 in Freeport, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 7, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Freeport, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 636 | 21 CFR 803.17(b)(2) | Reports and information documentation |