FDA Inspection
Flexicare Medical (Dongguan) Ltd.Flexicare Medical (Dongguan) Ltd. – FDA Inspection, Mar 21, 2024
Record Details
This FDA Inspection record concerns Flexicare Medical (Dongguan) Ltd., with an inspection on March 21, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 255a81a3-5917-44c6-94d0-5f1cd47e7d8b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1235507
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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Other FDA inspections of Flexicare Medical (Dongguan) Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 24, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 26, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Flexicare Medical (Dongguan) Ltd.
- FDA Inspection 816936 - 2013-01-24
- FDA Inspection 682638 - 2010-08-26
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