FDA Inspection
BCG Medical IncBCG Medical Inc – FDA Inspection, Sep 13, 2018
Record Details
This FDA Inspection record concerns BCG Medical Inc, with an inspection on September 13, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e273ec29-ff50-42f8-a809-64c046b05c38
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1065934
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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