FDA Inspection
Hinson and Hale Medical Technologies, Inc.Hinson and Hale Medical Technologies, Inc. – FDA Inspection, Apr 30, 2019
Record Details
This FDA Inspection record concerns Hinson and Hale Medical Technologies, Inc., with an inspection on April 30, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f60d88a0-2567-4996-877c-1058428f6b89
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087993
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - documentation
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Hinson and Hale Medical Technologies, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 26, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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