# FDA 483 - A Plus Phlebotomy Services - February 10, 2025

Source: https://www.keypedia.com/records/483/a-plus-phlebotomy-services/8e67e64a-c612-44ef-9413-a91cdd6d8914

> FDA 483 for A Plus Phlebotomy Services on February 10, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: A Plus Phlebotomy Services
- Inspection Date: 2025-02-10
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: A Plus Phlebotomy Services, a plasma donor center in Huntingdon Valley, PA, received a Form FDA 483 citing significant deficiencies during a February 2025 inspection. The observations highlight critical failures in donor screening, testing, and labeling for transfusion-transmitted infections, including Hepatitis B, HTLV, and Chagas disease. Additional concerns include inadequate record-keeping, uncalibrated equipment, missing standard operating procedures, and a lack of CPR-certified staff, indicating systemic issues in donor safety and quality control.

## Related Officers

- [Kish Bolden](https://www.keypedia.com/people/kish-bolden/e24957d4-927f-40c7-a7ca-860fedce2e3f)
- [issuing_officer](https://www.keypedia.com/people/emily-a-walters/e80b3581-ffba-4244-9030-b6c9496da932)

Company: https://www.keypedia.com/companies/a-plus-phlebotomy-services/46d3d267-335c-4bde-9d82-78f969a7153b

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8