FDA 483 - Dr. Reddy's Laboratories Limited - May 24, 2025
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An FDA inspection of Dr. Reddy's Laboratories Limited – CTO 5, an API manufacturer in Telangana, India, revealed two significant observations. The firm failed to ensure equipment surfaces were maintained in good repair, as a streak was found on a reactor after line clearance and was not recorded. Additionally, electronic batch records were deficient, showing identical date and time stamps for both first and second person reviews, indicating a lack of proper documentation for quality-related activities.
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