FDA Inspection
St. Mary's Regional HospitalSt. Mary's Regional Hospital – FDA Inspection, Mar 18, 2011
Record Details
This FDA Inspection record concerns St. Mary's Regional Hospital, with an inspection on March 18, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- St. Mary's Regional Hospital
- Inspection Date
- March 18, 2011
- Product Type
- Biologics
View Company Profile
ID · f991aef9-f3b6-4759-a1ba-33624e9cd57e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 716130
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
7- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 640.25(b)(4)Corrective action
- 21 CFR 640.25(b)Quality control
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 606.100(b)(10)Controlling storage temperatures
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of St. Mary's Regional Hospital
8| Date | Classification | Office | Project area |
|---|---|---|---|
| September 5, 2024 | Not classified | Denver District Office | |
| September 14, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 30, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 5, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 28, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for St. Mary's Regional Hospital
- FDA Inspection 1249087 - 2024-09-05
- FDA Inspection 1219955 - 2023-09-14
- FDA Inspection 1067775 - 2018-08-30
- FDA Inspection 985842 - 2016-08-05
- FDA Inspection 838220 - 2013-06-28
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