FDA Inspection
Hydrofera, LLCHydrofera, LLC – FDA Inspection, Aug 23, 2017
Record Details
This FDA Inspection record concerns Hydrofera, LLC, with an inspection on August 23, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 0789e502-72c9-46c8-a6cd-7a53044b8285
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1025048
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of Hydrofera, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 20, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Hydrofera, LLC
- FDA Inspection 846921 - 2013-09-04
- FDA Inspection 735431 - 2011-07-20
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