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FDA Inspection
•St. Francis Medical Center•February 28, 2014

St. Francis Medical Center – FDA Inspection, Feb 28, 2014

Record Details

This FDA Inspection record concerns St. Francis Medical Center, with an inspection on February 28, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
St. Francis Medical Center
Inspection Date
February 28, 2014
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 9e44bf5c-e01c-4909-a9e0-d12d58708862

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
868835
FDA center
Human Drugs
Project area
Bioresearch Monitoring

FDA Citations

5
  1. 21 CFR 56.115(a)(5)List of members
  2. 21 CFR 56.108(a)(2)More frequent reviews, verification of no changes
  3. 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
  4. 21 CFR 56.108(b)(3)Reporting of suspension/termination
  5. 21 CFR 56.110(b)Research not eligible for expedited review

Full citation text and observation details available on the Dashboard.

Other FDA inspections of St. Francis Medical Center

3
DateClassificationOfficeProject area
January 24, 2019Not classifiedNew Jersey District Office
January 29, 2018Not classifiedNew Jersey District Office
January 24, 2017Not classifiedNew Jersey District Office
Other documents for St. Francis Medical Center
  • FDA Inspection 1078013 - 2019-01-24
  • FDA Inspection 1040360 - 2018-01-29
  • FDA Inspection 998593 - 2017-01-24

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