U.S.FDA Pulls Up Aurobindo Pharma For ‘Repeated’ Failures
The U.S. Food and Drug Administration has pulled up Aurobindo Pharma Ltd. for 'repeated' violations in Current Good Manufacturing Practice at three of its plants in manufacturing certain Active Pharmaceutical Ingredients and intermediates.
The FDA recently issued a letter warning the drug- makers unit X1 in Srikakulam district of Andhra Pradesh for deviations from CGMP for API. ''The FDA cited similar CGMP observations at other facilities in your company’s network,'' the letter said.
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.
The repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs are inadequate, the regulator said.
In the letter issued on June 20 for unit XI which was inspected between Feb. 4 and 9, the FDA said the methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP and the API are adulterated within the meaning of U.S. laws.
The FDA directed the firm, among others, to provide a comprehensive assessment of the state of maintenance of all equipment that can be used in the manufacture of drugs for the United States.
Aurobindo had earlier said that it believed the existing business from unit XI facility would not be impacted after receiving the warning letter for it. "We will be engaging with the regulator and are fully-committed to resolving this issue at the earliest,'' Aurobindo said.
The company is also committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe, the company added.