FDA Inspection
Miami Stem Cell Treatment CenterMiami Stem Cell Treatment Center – FDA Inspection, Sep 11, 2015
Record Details
This FDA Inspection record concerns Miami Stem Cell Treatment Center, with an inspection on September 11, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 11, 2015
- Product Type
- Biologics
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ID · 2f65f01c-947a-4900-9b72-b975cb520cfc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 941769
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
10- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.67(b)Written procedures not established/followed
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