FDA Inspection
ImpactLifeImpactLife – FDA Inspection, May 21, 2015
Record Details
This FDA Inspection record concerns ImpactLife, with an inspection on May 21, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- ImpactLife
- Inspection Date
- May 21, 2015
- Product Type
- Biologics
View Company Profile
ID · b9c04c81-9e92-4fa0-8cc9-7bd5043c4fef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 927426
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of ImpactLife
10| Date | Classification | Office | Project area |
|---|---|---|---|
| February 14, 2025 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 17, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 20, 2017 | Not classified | Kansas City District Office | |
| June 19, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 9, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for ImpactLife
- FDA Inspection 1261653 - 2025-02-14
- FDA Inspection 1107342 - 2019-10-17
- FDA Inspection 1032214 - 2017-11-20
- FDA Inspection 1017401 - 2017-06-19
- FDA Inspection 977294 - 2016-06-09
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