FDA Inspection
Ascension St. Mary's HospitalAscension St. Mary's Hospital – FDA Inspection, Feb 4, 2011
Record Details
This FDA Inspection record concerns Ascension St. Mary's Hospital, with an inspection on February 4, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 4, 2011
- Product Type
- Biologics
View Company Profile
ID · e746831e-7e62-4a45-9ce7-11719d6c3fd6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 711732
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 600.10(b)Personnel capabilities
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
- 21 CFR 606.100(b)(3)Preparation of phlebotomy site
- 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 Ascension St. Mary's Hospital
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 5, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 26, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 26, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 28, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 9, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Ascension St. Mary's Hospital
- FDA Inspection 1105242 - 2019-09-05
- FDA Inspection 999240 - 2017-01-26
- FDA Inspection 916243 - 2015-02-26
- FDA Inspection 820805 - 2013-02-28
- FDA Inspection 560468 - 2009-01-09
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.