483
MedStar Georgetown Medical Center Inc Georgetown University HospitalMedStar Georgetown Medical Center Inc Georgetown University Hospital – FDA 483, Sep 10, 2019
Record Details
An FDA inspection of Medstar Georgetown University Hospital's Blood Bank identified significant deficiencies. The hospital failed to submit four biological product deviation reports to the FDA concerning incorrect or mislabeled blood units. Additionally, written standard operating procedures for investigating product deviations were not updated to reflect the current electronic reporting system.
- Inspection date
- September 10, 2019
- Product type
- biologics
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ID · 77c2b902-a9af-45f1-b2c2-a9498a99aae3
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