FDA 483 - Blue Elephant Inc - May 16, 2025

Blue Elephant Inc, a specification developer in Southlake, TX, received a Form FDA 483 with nine observations following an inspection. The findings indicate significant deficiencies in the firm's quality system, particularly regarding the establishment and maintenance of design control documentation for its Denture Retention Attachment device. Key issues include the absence of design history files, device master records, and design plans, alongside inadequate documentation for design inputs, outputs, reviews, verifications, supplier evaluations, and personnel training.