USFDA pulls up Aurobindo Pharma for 'repeated' failures in CGMP

04 Jul 2019

The US Food and Drug Administration (USFDA) has pulled up Aurobindo Pharma for 'repeated' violations in current good manufacturing practice (CGMP) at three of its plants in manufacturing certain active pharmaceutical ingredients (API) and intermediates. The repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs are inadequate.

The FDA recently issued a letter warning the drug- makers unit X1 in Srikakulam district of Andhra Pradesh for deviations from CGMP for API. Aurobindo unit I and Aurobindo unit IX were also inspected and cited for CGMP deficiencies related to the manufacture of (b)(4) API and intermediates.  These facilities were also considered to be in an unacceptable state of compliance with regards to CGMP.

Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.

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