483
Azico Biophore India Private LimitedAzico Biophore India Private Limited – FDA 483, Sep 1, 2025
Record Details
An FDA inspection of Azico Biophore India Private Limited, an API manufacturer, revealed significant deficiencies in their cleaning validation processes. The firm failed to adequately evaluate endotoxin contamination for equipment used in manufacturing sterile APIs and did not conduct comprehensive impact assessments for changes to critical cleaning validation procedures. These issues indicate a lack of robust quality control for products intended for sterile finished dosage drug products.
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ID · e4424993-a9f7-47d7-8c8d-3360f7a67b79
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