FDA Inspection
Higi SH LLCHigi SH LLC – FDA Inspection, Aug 17, 2017
Record Details
This FDA Inspection record concerns Higi SH LLC, with an inspection on August 17, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5d776d24-942c-4e69-b16c-f7808786ea2a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1022007
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(j)Design history file
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Other FDA inspections of Higi SH LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Higi SH LLC
- FDA Inspection 847992 - 2013-09-04
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