FDA Inspection
Michael A. Werner MD PC/dba M.A.Z.E LaboratoriesMichael A. Werner MD PC/dba M.A.Z.E Laboratories – FDA Inspection, Jan 24, 2014
Record Details
This FDA Inspection record concerns Michael A. Werner MD PC/dba M.A.Z.E Laboratories, with an inspection on January 24, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 24, 2014
- Product Type
- Biologics
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ID · 1dfb7abd-61d2-4117-bdb7-f2227d6ed970
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 862323
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
1- 21 CFR 1271.90(c)Eligibility not required--warning labels
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Other FDA inspections of Michael A. Werner MD PC/dba M.A.Z.E Laboratories
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 6, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 19, 2022 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 20, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 8, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 17, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Michael A. Werner MD PC/dba M.A.Z.E Laboratories
- FDA Inspection 1248805 - 2024-09-06
- FDA Inspection 1177855 - 2022-08-19
- FDA Inspection 1058097 - 2018-06-20
- FDA Inspection 952440 - 2015-12-08
- FDA Inspection 753349 - 2011-11-17
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