FDA 483 - Lupin Limited - May 19, 2017
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Lupin Limited, a drug manufacturer in Indore, India, received a Form 483 with six observations during an FDA inspection. The firm demonstrated significant quality control issues, including a high rate of invalidated Out-of-Specification results attributed to human error and inadequate investigation records. Further concerns were raised regarding insufficient written procedures for process controls, deficient batch records, poorly qualified stability chambers, and a lack of procedures for equipment maintenance.
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