A Plus Phlebotomy Services – FDA 483, Feb 10, 2025
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.
ID · 8e67e64a-c612-44ef-9413-a91cdd6d8914
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