# FDA 483 - Methodist Hospital Blood Bank - March 18, 2026

Source: https://www.keypedia.com/records/483/methodist-hospital-blood-bank/6689a453-5b52-4f5f-b83c-e7c4b5049ff0

> FDA 483 for Methodist Hospital Blood Bank on March 18, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Methodist Hospital Blood Bank
- Inspection Date: 2026-03-18
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Methodist Hospital Blood Bank in San Antonio, TX, received a Form 483 with two observations related to equipment maintenance and record-keeping. The inspection revealed failures in regularly scheduled maintenance and calibration of blood processing equipment, specifically an irradiator. Additionally, the facility failed to properly document and manage a malfunctioning blood product freezer, including lack of work orders and incident reports, which led to temperature excursions affecting stored blood products.

## Related Officers

- [investigator](https://www.keypedia.com/people/robert-m-tillman/091c720a-1240-468f-8b05-2b3f6f5a14bd)

Company: https://www.keypedia.com/companies/methodist-hospital-blood-bank/c0b70348-b830-4caf-ad4d-78fe76364b7d

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