FDA Inspection
Eurofins Donor & Product Testing LLCEurofins Donor & Product Testing LLC – FDA Inspection, May 28, 2010
Record Details
This FDA Inspection record concerns Eurofins Donor & Product Testing LLC, with an inspection on May 28, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 28, 2010
- Product Type
- Biologics
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ID · 68dfc636-eb12-48df-9a21-70e98eea6e4f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 664330
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 606.160(a)(2)Determination of lot numbers and supplies
- 21 CFR 1271.160(a)Program is appropriate for the HCT/Ps
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.100(b)(14)QC procedures for supplies and reagents
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
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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