# FDA 483 - MedStar Georgetown Medical Center Inc Georgetown University Hospital - September 10, 2019

Source: https://www.keypedia.com/records/483/medstar-georgetown-medical-center-inc-georgetown-university-hospital/77c2b902-a9af-45f1-b2c2-a9498a99aae3

> FDA 483 for MedStar Georgetown Medical Center Inc Georgetown University Hospital on September 10, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MedStar Georgetown Medical Center Inc Georgetown University Hospital
- Inspection Date: 2019-09-10
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: 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.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/brandon-l-mariner/c1ff0e66-552d-466a-9b49-a083d0211c94)

Company: https://www.keypedia.com/companies/medstar-georgetown-medical-center-inc-georgetown-university-hospital/84c9719d-f314-47eb-83f3-1978ac3011f4

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e