FDA Inspection
Biochemical Diagnostics IncBiochemical Diagnostics Inc – FDA Inspection, Apr 28, 2015
Record Details
This FDA Inspection record concerns Biochemical Diagnostics Inc, with an inspection on April 28, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Biochemical Diagnostics Inc
- Inspection Date
- April 28, 2015
- Product Type
- Devices
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ID · a3eca2b4-40c0-4112-af6b-beee57c11714
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 923244
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Biochemical Diagnostics Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 4, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 10, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 17, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Biochemical Diagnostics Inc
- FDA Inspection 1136665 - 2021-03-04
- FDA Inspection 803130 - 2012-10-10
- FDA Inspection 655452 - 2010-02-17
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