FDA Inspection
Empire MedicalEmpire Medical – FDA Inspection, Aug 24, 2018
Record Details
This FDA Inspection record concerns Empire Medical, with an inspection on August 24, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · e72195e3-7878-40ae-bbd0-ff227442f822
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1063851
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 1271.260(e)Periodic review of temperatures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Empire Medical
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2025 | Not classified | Los Angeles District Office | |
| June 22, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 16, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 25, 2009 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Empire Medical
- FDA Inspection 1278407 - 2025-08-06
- FDA Inspection 985987 - 2016-06-22
- FDA Inspection 803242 - 2012-10-16
- FDA Inspection 630482 - 2009-11-25
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