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FDA Inspection
•Corvus Medical, Inc.•May 22, 2012

Corvus Medical, Inc. – FDA Inspection, May 22, 2012

Record Details

This FDA Inspection record concerns Corvus Medical, Inc., with an inspection on May 22, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Corvus Medical, Inc.
Inspection Date
May 22, 2012
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 50545df5-706e-44c6-bcaf-173cf86ef971

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
783195
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

4
  1. 21 CFR 1271.290(e)Documenting disposition of each HCT/P
  2. 21 CFR 1271.180(a)Procedures to meet core CTGP
  3. 21 CFR 1271.265(f)Return to inventory--procedures
  4. 21 CFR 1271.320(a)Procedures re complaints

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Corvus Medical, Inc.

3
DateClassificationOfficeProject area
May 23, 2018NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
May 19, 2015NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
March 19, 2013VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for Corvus Medical, Inc.
  • FDA Inspection 1054910 - 2018-05-23
  • FDA Inspection 927866 - 2015-05-19
  • FDA Inspection 825199 - 2013-03-19

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