FDA Inspection
University of South Alabama Children's and Women's HospitalUniversity of South Alabama Children's and Women's Hospital – FDA Inspection, Jan 22, 2019
Record Details
This FDA Inspection record concerns University of South Alabama Children's and Women's Hospital, with an inspection on January 22, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 22, 2019
- Product Type
- Biologics
View Company Profile
ID · eec6bf52-cc1d-432e-b492-a5f7376ae081
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1076900
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 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 University of South Alabama Children's and Women's Hospital
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 22, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 22, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 11, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 31, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for University of South Alabama Children's and Women's Hospital
- FDA Inspection 1251679 - 2024-09-18
- FDA Inspection 1169075 - 2022-04-22
- FDA Inspection 1015575 - 2017-06-22
- FDA Inspection 913526 - 2015-02-11
- FDA Inspection 834005 - 2013-05-31
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.