# FDA 483 - Houchin Community Blood Bank - October 30, 2024

Source: https://www.keypedia.com/records/483/houchin-community-blood-bank/2f7bb5af-e9d9-47fd-ba5d-41f0ffd03b39

> FDA 483 for Houchin Community Blood Bank on October 30, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Houchin Community Blood Bank
- Inspection Date: 2024-10-30
- Product Type: biologics
- Office Name: San Francisco District Office
- Summary: Houchin Community Blood Bank received a Form FDA 483 for multiple deficiencies observed during an inspection from October 22-30, 2024. The observations include failures in donor eligibility screening for plateletpheresis, inadequate phlebotomy site preparation, non-adherence to standard operating procedures for donor identification, and deficiencies in obtaining informed consent from apheresis donors. These issues indicate a lack of control over critical blood collection processes.

## Related Officers

- [Shelley H. Beausoleil](https://www.keypedia.com/people/shelley-h-beausoleil/1212116b-e24d-4bbc-a27a-5c16334d573e)

Company: https://www.keypedia.com/companies/houchin-community-blood-bank/2b4e2a86-b7fb-4007-93a9-18f0b76118e3

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df
