483
KEDPLASMA LLCKEDPLASMA LLC – FDA 483
Record Details
An inspection of BPL Plasma, Inc. in El Paso, Texas, revealed that the firm failed to provide complete test results for relevant transfusion-transmitted infections to deferred donors. Specifically, information letters lacked confirmatory or supplemental test results for conditions like syphilis, hepatitis B, anti-HCV, and HIV. This indicates deficiencies in donor counseling and the firm's standard operating procedures.
- Company
- KEDPLASMA LLC
- Product type
- biologics
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ID · 5e489d1f-0f8c-4169-b6a3-d392188a399c
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