FDA Inspection
Alaris Biologic Technologies, Inc.Alaris Biologic Technologies, Inc. – FDA Inspection, Apr 29, 2016
Record Details
This FDA Inspection record concerns Alaris Biologic Technologies, Inc., with an inspection on April 29, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 29, 2016
- Product Type
- Biologics
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ID · 515dc2ee-3f99-4203-abfa-afd2653a3679
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 987207
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.200(e)Documentation of maintenance and cleaning
- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 1271.270(c)Back-up of electronic records
- 21 CFR 1271.150(c)(1)(iii)Ensurane of compliance
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Other FDA inspections of Alaris Biologic Technologies, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2018 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 13, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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