FDA Inspection
Well-Life Healthcare LimitedWell-Life Healthcare Limited – FDA Inspection, Dec 2, 2010
Record Details
This FDA Inspection record concerns Well-Life Healthcare Limited, with an inspection on December 2, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Well-Life Healthcare Limited
- Inspection Date
- December 2, 2010
- Product Type
- Devices
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ID · 5b4b29de-70e2-45b2-9a00-e8b5c634868e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 704481
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
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Other FDA inspections of Well-Life Healthcare Limited
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 1, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 29, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Well-Life Healthcare Limited
- FDA Inspection 1015062 - 2017-06-01
- FDA Inspection 852984 - 2013-08-29
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