483
Laurus Labs LimitedFDA 483 - Laurus Labs Limited - June 14, 2019
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Laurus Labs Limited, an Active Pharmaceutical Ingredient manufacturer in Parwada, India, was cited for two significant issues during an FDA inspection. The firm failed to adequately document preventative and corrective actions for various investigations and lacked complete records for API labeling. These observations indicate deficiencies in quality system documentation and record-keeping practices.
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ID · 561ad5c6-ede4-4617-835c-81b6b1ac8955