483
Aurobindo Pharma LtdFDA 483 - Aurobindo Pharma Ltd - May 24, 2019
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Aurobindo Pharma Ltd in Medchal, India, received a Form 483 with 10 observations during an inspection from May 13-24, 2019. The observations highlight significant deficiencies in quality control, data integrity, equipment cleaning, complaint handling, and computer system controls, indicating a lack of adherence to cGMP regulations. These issues raise concerns about the quality and reliability of drug products manufactured at the facility.
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ID · ed01b8a9-88db-401b-b91c-4b4446c83461