FDA Inspection 1098867 — Environmental Tectonics Corp
The FDA completed an inspection of Environmental Tectonics Corp on August 1, 2019 in Southampton, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 1, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Southampton, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 21425 | 21 CFR 820.184(f) | DHR - UDI not included |
| 3159 | 21 CFR 820.184 | DHR content |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3347 | 21 CFR 820.200(c) | Service reports/MDRs/complaints |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4060 | 21 CFR 820.20(b)(3)(i) | Management representative implementing the quality system |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |