FDA 483 - Eurofins Biopharma Product Testing Munich GmbH - July 12, 2019

An FDA inspection of Eurofins Biopharma Product Testing Munich GmbH, a contract testing laboratory, revealed significant deficiencies in laboratory records. The firm failed to maintain complete data for stability testing, with issues noted in audit trail review, and did not adequately verify microbial enumeration data against raw colony counts. These findings indicate concerns regarding data integrity and record-keeping practices.