FDA WARNING_LETTER - Madespa S.A. - April 24, 2008

On April 21-24, 2008, an FDA inspection of Madespa S.A. in Toledo, Spain, revealed that their dental devices (amalgam, composites, adhesives, etching gel, etc.) are adulterated under 21 U.S.C. §351(h) due to non-conformity with Quality System (QS) regulation 21 CFR Part 820.

Key violations include: 1. Failure to establish and maintain procedures for formal documented design reviews (21 CFR §820.30(e)). 2. Failure to establish and maintain procedures to ensure design translation into production specifications (21 CFR §820.30(h)). 3. Failure to establish and maintain procedures for documenting, validating, reviewing, and approving design changes before implementation (21 CFR §820.30(i)). 4. Failure to evaluate complaints for potential Medical Device Report (MDR) events (21 CFR §820.198(a)(3)). 5. Failure to develop, conduct, control, and monitor production processes to ensure device conformity to specifications, including documented instructions and SOPs (21 CFR §820.70(a)). Specific examples include unperformed density and pH tests. 6. Failure to evaluate and select suppliers based on quality requirements and document evaluations,