FDA Inspection
Active MedicalActive Medical – FDA Inspection, Dec 12, 2019
Record Details
This FDA Inspection record concerns Active Medical, with an inspection on December 12, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Active Medical
- Inspection Date
- December 12, 2019
- Product Type
- Biologics
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ID · d9927a0f-29b9-4366-8b03-808d389351d5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1112479
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.170(c)Trained or re-trained as necessary
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.260(e)Periodic review of temperatures
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Active Medical
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 21, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Active Medical
- FDA Inspection 1043761 - 2018-02-21
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