FDA Inspection
Manhattan Regenerative Medicine Medical GroupManhattan Regenerative Medicine Medical Group – FDA Inspection, Sep 19, 2015
Record Details
This FDA Inspection record concerns Manhattan Regenerative Medicine Medical Group, with an inspection on September 19, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 19, 2015
- Product Type
- Biologics
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ID · 27885612-b807-4a14-b6dc-88c63566692d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 940147
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
9- 21 CFR 211.188(b)(11)Identification of persons involved, each significant step
- 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 211.113(b)Procedures for sterile drug products
- 21 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.22(a)Lack of quality control unit
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