FDA Inspection
Well-Life Healthcare LimitedWell-Life Healthcare Limited – FDA Inspection, Jun 1, 2017
Record Details
This FDA Inspection record concerns Well-Life Healthcare Limited, with an inspection on June 1, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 102cd2b6-4426-4e7e-89e0-0f3768b102de
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1015062
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
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Other FDA inspections of Well-Life Healthcare Limited
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 2, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Well-Life Healthcare Limited
- FDA Inspection 852984 - 2013-08-29
- FDA Inspection 704481 - 2010-12-02
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