FDA Inspection
Alaris Biologic Technologies, Inc.Alaris Biologic Technologies, Inc. – FDA Inspection, May 13, 2015
Record Details
This FDA Inspection record concerns Alaris Biologic Technologies, Inc., with an inspection on May 13, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 13, 2015
- Product Type
- Biologics
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ID · 9d333107-5791-4255-bd65-384d868665e4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 926000
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
12- 21 CFR 1271.230(c)Changes to validated process
- 21 CFR 1271.195(d)Documentation not maintained
- 21 CFR 1271.190(d)(2)Documentation of activities
- 21 CFR 1271.195(a)Adequate control, proper conditions
- 21 CFR 1271.200(d)Inspected routinely
- 21 CFR 1271.190(b)(1)Clean, sanitary, orderly manner
- 21 CFR 1271.190(d)(1)Description of methods, schedule
- 21 CFR 1271.150(c)(2)Responsibility for review before distribution
- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 1271.170(b)Not qualified, authorized for functions
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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 |
| April 29, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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