FDA Inspection
M.A.Z.E. LaboratoriesM.A.Z.E. Laboratories – FDA Inspection, May 28, 2009
Record Details
This FDA Inspection record concerns M.A.Z.E. Laboratories, with an inspection on May 28, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- M.A.Z.E. Laboratories
- Inspection Date
- May 28, 2009
- Product Type
- Biologics
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ID · 0e3f2c27-f143-4f93-8299-e650dc3918db
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 584284
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.160(a)Program is appropriate for the HCT/Ps
- 21 CFR 1271.90(c)(1)Autologous use only--labeling
- 21 CFR 1271.150(c)(1)(iii)Ensurane of compliance
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Other FDA inspections of M.A.Z.E. Laboratories
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 16, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 17, 2021 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 25, 2018 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 10, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 14, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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