FDA Inspection
ImpactLifeImpactLife – FDA Inspection, Dec 16, 2010
Record Details
This FDA Inspection record concerns ImpactLife, with an inspection on December 16, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- ImpactLife
- Inspection Date
- December 16, 2010
- Product Type
- Biologics
View Company Profile
ID · 7d08d03e-8391-4249-9b39-88299caa3946
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 702415
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 610.40(b)One or more approved screening tests
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 211.194(a)(2)Laboratory Test Method Verification
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
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
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.