FDA Inspection
Bio Tech Med Corp.Bio Tech Med Corp. – FDA Inspection, Jul 2, 2013
Record Details
This FDA Inspection record concerns Bio Tech Med Corp., with an inspection on July 2, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Bio Tech Med Corp.
- Inspection Date
- July 2, 2013
- Product Type
- Biologics
View Company Profile
ID · 7a5cfcb9-1062-4811-8a9f-259d47e474c6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 839741
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.180(b)Review and approval-responsible person
- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of Bio Tech Med Corp.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 31, 2020 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 7, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 27, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 11, 2009 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Bio Tech Med Corp.
- FDA Inspection 1117665 - 2020-01-31
- FDA Inspection 1037952 - 2017-12-07
- FDA Inspection 947311 - 2015-10-27
- FDA Inspection 635042 - 2009-12-11
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