FDA Inspection
St Joseph Regional Health Network dba Penn State Health St. JosephSt Joseph Regional Health Network dba Penn State Health St. Joseph – FDA Inspection, Aug 12, 2015
Record Details
This FDA Inspection record concerns St Joseph Regional Health Network dba Penn State Health St. Joseph, with an inspection on August 12, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 12, 2015
- Product Type
- Drugs
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ID · f30802a9-c7de-472f-8959-279cc49ea8f7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 938541
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(1)Initial and continuing reviews
Full citation text and observation details available on the Dashboard.
Other FDA inspections of St Joseph Regional Health Network dba Penn State Health St. Joseph
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 28, 2025 | Not classified | Philadelphia District Office | |
| January 23, 2020 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 21, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 8, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 24, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for St Joseph Regional Health Network dba Penn State Health St. Joseph
- FDA Inspection 1263411 - 2025-02-28
- FDA Inspection 1119278 - 2020-01-23
- FDA Inspection 1044566 - 2018-02-21
- FDA Inspection 966735 - 2016-04-08
- FDA Inspection 849687 - 2013-09-24
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