# FDA 483 - Gulf Coast Regional Blood Center - September 14, 2022

Source: https://www.globalkeysolutions.net/records/483/gulf-coast-regional-blood-center/b1fea2b7-61ec-46d6-ac20-bacb31a3e38b

> FDA 483 for Gulf Coast Regional Blood Center on September 14, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gulf Coast Regional Blood Center
- Inspection Date: 2022-09-14
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Gulf Coast Regional Blood Center in Houston, TX, revealed a significant issue regarding donor eligibility. The firm failed to properly defer a donor of blood and blood components, despite their own reference table indicating an indefinite deferral. This indicates a lapse in adherence to established donor screening protocols.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/sunitha-k-rajaram/1a0872d4-5e7b-4690-a2be-3877aec25053)
- [Bobbi Miller](https://www.globalkeysolutions.net/people/bobbi-miller/60517ce9-0fee-4099-98ef-c7329af0518a)
- [investigator](https://www.globalkeysolutions.net/people/maira-p-brading/892072f4-e584-48d1-890c-e0a47dfbdffa)

Company: https://www.globalkeysolutions.net/companies/gulf-coast-regional-blood-center/7bef4346-91b9-4489-9ca6-b45fb4424760

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab