FDA Inspection
Phelps Memorial Hospital CenterPhelps Memorial Hospital Center – FDA Inspection, Jun 10, 2010
Record Details
This FDA Inspection record concerns Phelps Memorial Hospital Center, with an inspection on June 10, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 10, 2010
- Product Type
- Biologics
View Company Profile
ID · 6ce22e8b-15b5-461d-b15c-e5afe61958da
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 665186
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 606.40(c)Provide adequate toilet facilities
- 21 CFR 820.75(a)Documentation
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Phelps Memorial Hospital Center
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 2, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 22, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 30, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 27, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Phelps Memorial Hospital Center
- FDA Inspection 1063799 - 2018-08-02
- FDA Inspection 975319 - 2016-06-22
- FDA Inspection 896965 - 2014-09-30
- FDA Inspection 800434 - 2012-09-27
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.