FDA Inspection
TMC Orthopedic Hanger ClinicTMC Orthopedic Hanger Clinic – FDA Inspection, Oct 18, 2018
Record Details
This FDA Inspection record concerns TMC Orthopedic Hanger Clinic, with an inspection on October 18, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · b6acea76-d954-433e-9b1f-04f025093856
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1069476
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.195(d)Documentation not maintained
- 21 CFR 1271.200(c)Calibration procedures and schedules (general)
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Other FDA inspections of TMC Orthopedic Hanger Clinic
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 26, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 9, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for TMC Orthopedic Hanger Clinic
- FDA Inspection 919159 - 2015-03-20
- FDA Inspection 800853 - 2012-09-26
- FDA Inspection 697269 - 2010-11-09
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