FDA Inspection
St. Mary's Regional HospitalSt. Mary's Regional Hospital – FDA Inspection, Aug 5, 2016
Record Details
This FDA Inspection record concerns St. Mary's Regional Hospital, with an inspection on August 5, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- St. Mary's Regional Hospital
- Inspection Date
- August 5, 2016
- Product Type
- Biologics
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ID · d4690acd-15d4-425d-b2a5-618d01393f61
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 985842
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
12- 21 CFR 606.60(a)Provide proper equipment to meet requirements
- 21 CFR 640.21(g)Informed consent
- 21 CFR 606.160(b)Required records
- 21 CFR 640.21(e)Frequency of plateletpheresis
- 21 CFR 606.40Suitable size, construction, etc.
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
Showing 10 of 12 citations.
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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 |
| June 28, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 15, 2012 | OAI | 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 838220 - 2013-06-28
- FDA Inspection 787023 - 2012-06-15
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