FDA Inspection
Eagle Ortho LLCEagle Ortho LLC – FDA Inspection, Oct 23, 2017
Record Details
This FDA Inspection record concerns Eagle Ortho LLC, with an inspection on October 23, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · b4b3f25b-0949-457e-8bd4-6fe01f34760c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1029481
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 1271.180(a)Procedures to meet core CTGP
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Other FDA inspections of Eagle Ortho LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 5, 2020 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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