FDA 483 - BioLife Plasma Services L.P. - March 04, 2026

An FDA inspection of BioLife Plasma Services L.P. in Fayetteville, NC, from February 24 to March 4, 2026, identified one observation. The firm was cited for failing to ensure equipment performed as designed, specifically regarding the lack of performance qualification for new apheresis machines used for source plasma collections. This indicates a significant lapse in equipment validation practices.