Continental Services Group, Inc. – FDA 483, May 31, 2019

An FDA inspection of Continental Services Group, Inc., a blood and source plasma donor center in Ft Lauderdale, FL, revealed significant deficiencies in their written standard operating procedures. The firm failed to establish and follow SOPs for calibrating blood pressure monitors, detailing physical exams for plasma donors, and properly documenting donor screening observations. These issues indicate a lack of adequate controls over critical aspects of blood and blood component collection.