FDA Inspection
Hydrofera, LLCHydrofera, LLC – FDA Inspection, Jul 20, 2011
Record Details
This FDA Inspection record concerns Hydrofera, LLC, with an inspection on July 20, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Hydrofera, LLC
- Inspection Date
- July 20, 2011
- Product Type
- Devices
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ID · b4d081d9-ea42-47a7-8b3f-fdf2af19b728
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 735431
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
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Other FDA inspections of Hydrofera, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 23, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 4, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Hydrofera, LLC
- FDA Inspection 1025048 - 2017-08-23
- FDA Inspection 846921 - 2013-09-04
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