SENSONICS, INTERNATIONAL – FDA 483, Feb 10, 2025

SENSONICS, INTERNATIONAL, a manufacturer in Haddon Heights, NJ, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate procedures for internal quality audits, a failure to conduct proper supplier evaluations, and a lack of clear instructions for supplier scoring. Additionally, the firm lacked process validation for a Flexographic Press used in product labeling.