FDA 483 - Cartibras Animal Products Processing Company Ltd. - December 06, 2019

Cartibras Beneficiadora De Produtos Animais Ltda, an API manufacturer in Iomere, Brazil, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to adequately follow quality control unit responsibilities, maintain proper laboratory controls, and establish a robust stability testing program. Additionally, issues with equipment cleaning and maintenance, and incomplete batch production records were noted, indicating a broad lack of adherence to good manufacturing practices.