FDA Inspection
Bien Air Dental SABien Air Dental SA – FDA Inspection, Sep 12, 2013
Record Details
This FDA Inspection record concerns Bien Air Dental SA, with an inspection on September 12, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bien Air Dental SA
- Inspection Date
- September 12, 2013
- Product Type
- Devices
View Company Profile
ID · 00b28bdc-09ed-4406-961c-8477161e331d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 849506
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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