FDA WARNING_LETTER - Copan ltalia - January 17, 2012

An FDA inspection of Copan Italia in Brescia, Italy, from January 13-17, 2012, revealed that the firm's Universal Transport Media and WASP analysis equipment are adulterated. The manufacturing methods, facilities, or controls do not conform to the Quality System (QS) regulation, 21 CFR Part 820. The firm's February 2, 2012, response to the FDA 483 was deemed inadequate as it lacked evidence of implementation and systemic corrective actions.

Key violations include failures in process validation (21 CFR 820.75(a)), establishing data for purchased products (21 CFR 820.50(b)), implementing adequate corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)), managing changes to specifications/procedures (21 CFR 820.70(b)), establishing complaint handling procedures (21 CFR 820.1 98(a)), controlling documents (21 CFR 820.40), and preventing contamination (21 CFR 820.70(e)).

The FDA warns that these deficiencies could impact federal contracts, premarket approvals for Class III devices, and Certificates to Foreign Governments. Copan Italia must respond within fifteen business days, detailing specific corrections, prevention plans, documentation, and a timetable for long-term actions to address these serious manufacturing and quality management system problems.