FDA Inspection
ImpactOrtho Inc HawaiiImpactOrtho Inc Hawaii – FDA Inspection, Feb 28, 2019
Record Details
This FDA Inspection record concerns ImpactOrtho Inc Hawaii, with an inspection on February 28, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 93e339ea-8cba-474a-b559-e53432047d0e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1080781
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.260(a)Contamination, mix ups, improper release
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