FDA Inspection
Exalt MedicalExalt Medical – FDA Inspection, Oct 23, 2018
Record Details
This FDA Inspection record concerns Exalt Medical, with an inspection on October 23, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 6401c37b-0e81-4262-acbe-adbbc5867e19
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1069961
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 1271.200(c)Calibrated per established schedules
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.320(a)Procedures re complaints
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
- 21 CFR 1271.200(c)Calibration procedures and schedules (general)
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