FDA Inspection
HDT Expeditionary System, Inc.HDT Expeditionary System, Inc. – FDA Inspection, Aug 31, 2017
Record Details
This FDA Inspection record concerns HDT Expeditionary System, Inc., with an inspection on August 31, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7ac65a72-1908-4776-ae67-2d3cd6a99006
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1023697
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.70(i)Software validation for automated processes
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