FDA 483 - Vericel Corporation

Vericel Corporation in Burlington, MA, was inspected from February 2-6, 2026, and received a Form 483. The inspection revealed significant deficiencies in aseptic processing practices and procedures for MACI drug product manufacturing. Operators were observed compromising aseptic conditions by exiting and re-entering biological safety cabinets without proper garment changes, and the firm's SOPs lacked critical detail regarding personnel hygiene and cleanroom practices.