FDA 483 - Cipla Ltd. - January 20, 2020
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An FDA inspection of Cipla Limited, an API manufacturer in Bangalore, India, from January 20-24, 2020, revealed significant deficiencies in their production and equipment systems. Observations included inadequate process monitoring, insufficient process validation protocols for impurity testing, incomplete batch records, and a lack of proper operational qualification for equipment. These issues indicate a failure to ensure consistent product quality and adherence to manufacturing standards.
ID · 188882e0-4d67-4abb-bd52-e0728ee71ad4