FDA Inspection
Flexicare Medical (Dongguan) Ltd.Flexicare Medical (Dongguan) Ltd. – FDA Inspection, Aug 26, 2010
Record Details
This FDA Inspection record concerns Flexicare Medical (Dongguan) Ltd., with an inspection on August 26, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 26, 2010
- Product Type
- Devices
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ID · 60847bd1-9e6d-4061-bfa6-f7fb3db02caa
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 682638
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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Other FDA inspections of Flexicare Medical (Dongguan) Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 24, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Flexicare Medical (Dongguan) Ltd.
- FDA Inspection 1235507 - 2024-03-21
- FDA Inspection 816936 - 2013-01-24
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