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FDA Inspection
•Immanuel-St Joseph's-Mayo Health System•February 3, 2010

Immanuel-St Joseph's-Mayo Health System – FDA Inspection, Feb 3, 2010

Record Details

This FDA Inspection record concerns Immanuel-St Joseph's-Mayo Health System, with an inspection on February 3, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Immanuel-St Joseph's-Mayo Health System
Inspection Date
February 3, 2010
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 2770eb42-5651-4b25-b852-7a4579de3689

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
649023
FDA center
Human Drugs
Project area
Bioresearch Monitoring

FDA Citations

4
  1. 21 CFR 56.104(c)Emergency use and IRB approval
  2. 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
  3. 21 CFR 56.108(a)(1)Initial and continuing reviews
  4. 21 CFR 56.110(b)(2)Minor changes

Full citation text and observation details available on the Dashboard.

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