FDA Inspection
UNM HospitalsUNM Hospitals – FDA Inspection, Oct 13, 2011
Record Details
This FDA Inspection record concerns UNM Hospitals, with an inspection on October 13, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- UNM Hospitals
- Inspection Date
- October 13, 2011
- Product Type
- Biologics
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ID · f1954ff8-f4dc-47f3-a0dc-d133fbd9d9d5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 753196
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 606.60(a)Maintain and clean equipment
- 21 CFR 606.121(f)Labeling of blood products unsuitable for transfusion
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of UNM Hospitals
9| Date | Classification | Office | Project area |
|---|---|---|---|
| July 26, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 22, 2021 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 11, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 18, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 2, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for UNM Hospitals
- FDA Inspection 1247060 - 2024-07-26
- FDA Inspection 1157844 - 2021-11-22
- FDA Inspection 1112296 - 2019-10-11
- FDA Inspection 1053023 - 2018-04-18
- FDA Inspection 979752 - 2016-03-02
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