FDA Inspection
Trent ArsenaultTrent Arsenault – FDA Inspection, Sep 16, 2010
Record Details
This FDA Inspection record concerns Trent Arsenault, with an inspection on September 16, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Trent Arsenault
- Inspection Date
- September 16, 2010
- Product Type
- Biologics
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ID · 29df4702-ceef-4286-9851-ef9af372ccd9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 680747
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.55(a)(3)Summary--records used to make determination
- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.47(a)Procedures for all other requirements
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