FDA Inspection
Alaris Biologic Technologies, Inc.Alaris Biologic Technologies, Inc. – FDA Inspection, Mar 2, 2018
Record Details
This FDA Inspection record concerns Alaris Biologic Technologies, Inc., with an inspection on March 2, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- People
- Barbara T. Carmichael (FDA Associated Person)
- Mizanne E. Lewis (Company Rep)
- Valerie J. Grecek-Trinh (Issuing Officer)
View Company Profile
ID · 8f6aa040-31e0-4c5b-b564-63639f159319
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042813
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1271.230(a)Documented, dated, signed
- 21 CFR 1271.230(c)Changes to validated process
- 21 CFR 1271.350(b)(2)Deviations not reported to FDA
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Alaris Biologic Technologies, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 29, 2016 | 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 |
Other documents for Alaris Biologic Technologies, Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.