FDA 483 - Zen Chemicals Private Limited - March 28, 2023
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Zen Chemicals Pvt. Ltd. in Dombivili, India, was cited for significant deficiencies in equipment cleaning and sanitation, data integrity, and quality system controls. The inspection revealed visibly dirty equipment, a lack of investigations into analytical data discrepancies, inadequate computer system access controls, and untrained cleaning personnel. These issues indicate a serious breakdown in maintaining a state of control for critical API intermediate manufacturing.
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