FDA Inspection
Heany Industries IncorporatedHeany Industries Incorporated – FDA Inspection, Nov 2, 2018
Record Details
This FDA Inspection record concerns Heany Industries Incorporated, with an inspection on November 2, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ebf761e4-15ce-4f37-9905-d51114e9ec3f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1071071
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of Heany Industries Incorporated
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 23, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Heany Industries Incorporated
- FDA Inspection 1165401 - 2022-03-23
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