FDA Inspection
ImpactLifeImpactLife – FDA Inspection, Jul 1, 2013
Record Details
This FDA Inspection record concerns ImpactLife, with an inspection on July 1, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- ImpactLife
- Inspection Date
- July 1, 2013
- Product Type
- Biologics
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ID · d103c06d-a6e4-4685-8f39-6d3bcbb04f25
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 837279
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of ImpactLife
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 23, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 1, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 19, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 21, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 8, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for ImpactLife
- FDA Inspection 1248537 - 2024-08-23
- FDA Inspection 1081569 - 2019-03-01
- FDA Inspection 988991 - 2016-10-19
- FDA Inspection 904330 - 2014-11-21
- FDA Inspection 709770 - 2011-02-08
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