FDA Inspection
Healgen Scientific LlcHealgen Scientific Llc – FDA Inspection, Nov 2, 2016
Record Details
This FDA Inspection record concerns Healgen Scientific Llc, with an inspection on November 2, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ab75abdb-7c98-4700-aef5-112aa1cb50a4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 995649
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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