# FDA 483 - Veterans Affairs Medical Center - February 20, 2013

Source: https://www.keypedia.com/records/483/veterans-affairs-medical-center/4d973180-5307-45a0-9507-20457f4cb911

> FDA 483 for Veterans Affairs Medical Center on February 20, 2013. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Veterans Affairs Medical Center
- Inspection Date: 2013-02-20
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: The Veterans Affairs Medical Center in Battle Creek, MI, was cited for failing to follow its written standard operating procedures related to the storage, distribution, and labeling of blood and blood components. Specifically, issues included improper thermometer calibration, incomplete blood transfusion records, and failure to use required red stickers for specimen identification. These findings indicate significant deviations from established procedures in their hospital blood bank operations.

## Related Officers

- [investigator](https://www.keypedia.com/people/bleta-vuniqi/942c599c-2fbb-4428-925d-728ad860f846)
- [U.S. Food and Drug Administration](https://www.keypedia.com/people/myra-k-casey/a2fae714-2ba3-4c60-9f54-990fc7b169c9)

Company: https://www.keypedia.com/companies/veterans-affairs-medical-center/47c72ba4-74a3-4d7b-9d97-ffce6a605b4a

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0
