FDA 483 - B & D Dental Corp. - September 05, 2023

B & D Dental Corp. in West Valley City, UT, a medical device manufacturer of zirconia discs, received a Form FDA 483 with 15 observations during an inspection from August 28 to September 5, 2023. The inspection revealed significant deficiencies across its quality system, including inadequate process validation, lack of design history files, poor complaint handling, and insufficient documentation for CAPA, DHRs, DMRs, supplier evaluation, and equipment maintenance. The findings indicate a systemic failure to establish and maintain essential quality system procedures for medical device manufacturing.