FDA Inspection
Flextronics America LLCFlextronics America LLC – FDA Inspection, Dec 27, 2013
Record Details
This FDA Inspection record concerns Flextronics America LLC, with an inspection on December 27, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Flextronics America LLC
- Inspection Date
- December 27, 2013
- Product Type
- Devices
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ID · 2bd12e88-4d89-449d-ad2f-b3a9e3309092
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 859108
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.120(b)Examination for accuracy
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
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Other FDA inspections of Flextronics America LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Flextronics America LLC
- FDA Inspection 786842 - 2012-06-06
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