FDA Inspection
Unilab of Dade, Inc.Unilab of Dade, Inc. – FDA Inspection, Feb 10, 2012
Record Details
This FDA Inspection record concerns Unilab of Dade, Inc., with an inspection on February 10, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Unilab of Dade, Inc.
- Inspection Date
- February 10, 2012
- Product Type
- Biologics
View Company Profile
ID · 71ca2091-0511-4434-97aa-0c7f0e988b21
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 766964
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.80(c)Manufacturer instructions not followed
- 21 CFR 1271.160(b)(6)Deviations--Investigation, documenting, trending
- 21 CFR 1271.160(b)(1)Ensuring appropriate core requirements followed
- 21 CFR 1271.160(b)(4)Training of personnel
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Unilab of Dade, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 26, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 10, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 2, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 9, 2009 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Unilab of Dade, Inc.
- FDA Inspection 1192576 - 2022-11-07
- FDA Inspection 1031497 - 2017-10-26
- FDA Inspection 907195 - 2014-12-10
- FDA Inspection 664521 - 2010-06-02
- FDA Inspection 618488 - 2009-10-09
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