FDA Inspection
Healthmate International LLCHealthmate International LLC – FDA Inspection, Dec 12, 2011
Record Details
This FDA Inspection record concerns Healthmate International LLC, with an inspection on December 12, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Healthmate International LLC
- Inspection Date
- December 12, 2011
- Product Type
- Devices
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ID · bdb84208-af0d-4e96-9a05-2f23b909e13f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 757299
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Healthmate International LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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