FDA 483 - Vericel Corporation - June 12, 2026

Vericel Corporation in Cambridge, MA, received a Form 483 with four observations highlighting significant deficiencies in their manufacturing and quality control processes. The inspection revealed inadequate investigations into product leakage and the use of expired materials, insufficient controls over computer systems for data integrity, and failures in maintaining accurate batch records. These issues collectively indicate a need for improved quality management to ensure product quality and sterility.