Apitoria Pharma Private Limited – FDA 483, Feb 2, 2019
An FDA inspection of Aurobindo Pharma Ltd, Unit 9, a manufacturer of starting materials and advanced intermediates in Gundlamachanoor Village, India, revealed significant deficiencies. The firm's investigations into genotoxic impurities were inadequate, and its cleaning validation processes for non-dedicated equipment were found to be deficient. Further issues included inadequate corrective and preventive actions, unvalidated analytical methods, and failures in laboratory equipment calibration and data integrity.
ID · 413edfc9-6cdb-41b0-851f-7ffd80aed504
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