FDA Inspection 1023697 — HDT Expeditionary System, Inc.
The FDA completed an inspection of HDT Expeditionary System, Inc. on August 31, 2017 in Fredericksburg, VA. 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 31, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fredericksburg, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |