FDA Inspection
FH INDUSTRIEFH INDUSTRIE – FDA Inspection, Sep 6, 2018
Record Details
This FDA Inspection record concerns FH INDUSTRIE, with an inspection on September 6, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 1decea7a-37fa-40d0-88e7-7f6f87404e49
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1064620
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of FH INDUSTRIE
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 19, 2025 | Not classified | Office of Inspections and Investigations | |
| July 23, 2015 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for FH INDUSTRIE
- FDA Inspection 1273707 - 2025-05-19
- FDA Inspection 940386 - 2015-07-23
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