FDA Inspection
Micro Essentials LabMicro Essentials Lab – FDA Inspection, Feb 14, 2011
Record Details
This FDA Inspection record concerns Micro Essentials Lab, with an inspection on February 14, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Micro Essentials Lab
- Inspection Date
- February 14, 2011
- Product Type
- Devices
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ID · 2f7ada2b-9412-41a8-bb94-a9c02a153d13
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 709852
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.22Quality Audit/Reaudit - documentation
- 21 CFR 820.20(c)Management review dates
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Micro Essentials Lab
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 12, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 21, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Micro Essentials Lab
- FDA Inspection 914067 - 2015-02-12
- FDA Inspection 808000 - 2012-11-21
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