# FDA 483 - B Positive National Blood Services - Cheltenham, LLC - August 24, 2022

Source: https://www.globalkeysolutions.net/records/483/b-positive-national-blood-services-cheltenham-llc/6006e660-aed4-43f3-8065-624c24ed00b5

> FDA 483 for B Positive National Blood Services - Cheltenham, LLC on August 24, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: B Positive National Blood Services - Cheltenham, LLC
- Inspection Date: 2022-08-24
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: B Positive National Blood Services - Cheltenham, LLC, a plasma center, was cited with two observations during an FDA inspection. The firm failed to ensure that the responsible physician approved the reinstatement of deferred donors with abnormal protein test results. Additionally, the facility did not store reagents and supplies according to manufacturer instructions or monitor their storage temperatures.

## Related Officers

- [Thaddeus Nndube](https://www.globalkeysolutions.net/people/thaddeus-nndube/9cdc17ca-554a-4ee8-9b70-8960a19b3a34)
- [Christopher Sy](https://www.globalkeysolutions.net/people/christopher-sy/429ca249-f950-43cc-b055-4b9b93bfba18)

Company: https://www.globalkeysolutions.net/companies/b-positive-national-blood-services-cheltenham-llc/fde39670-3d58-44b2-a33b-9871df286b7d

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd