FDA Inspection
Good Samaritan HospitalGood Samaritan Hospital – FDA Inspection, Apr 13, 2015
Record Details
This FDA Inspection record concerns Good Samaritan Hospital, with an inspection on April 13, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Good Samaritan Hospital
- Inspection Date
- April 13, 2015
- Product Type
- Biologics
View Company Profile
ID · 8d7eff52-910c-40ed-8af1-906df7b28b9f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 921980
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 630.40(a)Notification
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 606.100(b)(6)Methods of component preparation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Good Samaritan Hospital
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 20, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 1, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 1, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 3, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Good Samaritan Hospital
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.