FDA Inspection
Helix BiomedicsHelix Biomedics – FDA Inspection, Jul 21, 2017
Record Details
This FDA Inspection record concerns Helix Biomedics, with an inspection on July 21, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ae59442e-27a3-4823-a022-febfa5c3e1fe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1019462
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.66Unanticipated problems
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 50.25(a)(5)Confidentiality, FDA inspection of records
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