FDA 483 - K B Dental Products, Inc. - July 31, 2025

An FDA inspection of K B Dental Products, Inc. in Anaheim, CA, an HCT/P manufacturer specializing in storage and distribution, revealed significant deficiencies in their procedures. The firm failed to adequately maintain, implement, review, and revise procedures for the receipt and distribution of HCT/Ps. These lapses could compromise product acceptance, storage, and distribution specifications, potentially impacting the prevention of communicable disease transmission.