483
LABORATOIRES ANIOS AN ECOLAB COMPANYLABORATOIRES ANIOS AN ECOLAB COMPANY – FDA 483, Sep 12, 2024
Record Details
An FDA inspection of Laboratoires Anios, a drug manufacturer in Sainghin-en-Melantois, France, revealed significant deficiencies in their quality control systems. The firm failed to establish adequate specifications and testing procedures for raw materials and lacked a robust stability testing program for its drug products. These issues raise concerns about the identity, strength, quality, and purity of drugs manufactured and shipped to the U.S.
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ID · e790bb3e-e125-49d5-bf41-8ba0e6d89d4f
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