FDA Inspection
Eurofins Donor & Product Testing LLCEurofins Donor & Product Testing LLC – FDA Inspection, Mar 15, 2012
Record Details
This FDA Inspection record concerns Eurofins Donor & Product Testing LLC, with an inspection on March 15, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 15, 2012
- Product Type
- Biologics
View Company Profile
ID · 1943c0df-5a76-41f2-9ac5-de2c10ce73a5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 773280
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 1271.170(c)Trained or re-trained as necessary
- 21 CFR 1271.180(a)Procedures to meet core CTGP
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Other FDA inspections of Eurofins Donor & Product Testing LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| July 19, 2024 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 17, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 8, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 9, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 19, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Eurofins Donor & Product Testing LLC
- FDA Inspection 1245237 - 2024-07-19
- FDA Inspection 1090119 - 2019-05-17
- FDA Inspection 1073911 - 2018-11-08
- FDA Inspection 1026048 - 2017-06-09
- FDA Inspection 980778 - 2016-02-19
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