FDA Inspection
ImpactLifeImpactLife – FDA Inspection, Jun 28, 2019
Record Details
This FDA Inspection record concerns ImpactLife, with an inspection on June 28, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · d745c69c-21b3-4bac-b058-cf993f74d125
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1094850
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 606.160(b)Required records
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of ImpactLife
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 26, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for ImpactLife
- FDA Inspection 1008323 - 2017-01-26
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