FDA Inspection
Creganna MedicalCreganna Medical – FDA Inspection, Feb 20, 2014
Record Details
This FDA Inspection record concerns Creganna Medical, with an inspection on February 20, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Creganna Medical
- Inspection Date
- February 20, 2014
- Product Type
- Devices
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ID · 894c89d4-3fe5-4591-ac4d-141fcfacc980
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 870227
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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Other FDA inspections of Creganna Medical
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 18, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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