Cord for Life, Inc. – FDA 483, Jun 10, 2026

Cord for Life, Inc. in Altamonte Springs, FL, received an FDA Form 483 with eight observations following an inspection from June 1-10, 2026. The inspection revealed significant deficiencies in aseptic processing, production controls, investigation procedures, record-keeping, process validation, and stability and sterility testing for their PremierMax® CB injectable products. Several observations, including issues with investigations and stability testing, were repeats from a previous inspection, indicating persistent quality system failures.