FDA Inspection
Cell Marque CorporationCell Marque Corporation – FDA Inspection, Oct 7, 2016
Record Details
This FDA Inspection record concerns Cell Marque Corporation, with an inspection on October 7, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Seema S. Singh (Issuing Officer)
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ID · a7d8bd33-2614-4d5b-8048-85eaed884a50
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 988310
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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Other FDA inspections of Cell Marque Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 12, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cell Marque Corporation
- FDA Inspection 764317 - 2012-01-12
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