483
Sun Pharmaceutical Industries LtdFDA 483 - Sun Pharmaceutical Industries Ltd - May 13, 2024
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Sun Pharmaceuticals Industries Limited in Dahej, India, received a Form 483 for significant deficiencies in its API manufacturing operations. The inspection revealed issues with equipment maintenance, HVAC system operation, and pest control, all contributing to contamination risks. Additionally, the firm failed to adequately test impurity reference standards and lacked detailed sampling procedures for active pharmaceutical ingredients.
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