FDA Issues Warning Letter to Baxter’s Drug Manufacturing Plant Acquired in Claris Buy

In a warning letter issued by FDA on July 5, 2018, the agency found cGMP violations at Baxter International’s drug manufacturing facility in Ahmedabad, India, which the company got last year with its July 2017 acquisition of Claris Injectables. The warning letter is based on FDA’s inspection of the facility from July 27, 2017 to August 4, 2017.

During the inspection, investigators observed defective batches that were not thoroughly investigated; incomplete batch production and control records; and lack of good building maintenance where manufacturing, processing, packaging, or drug storage took place.

In response to the letter, Baxter is required to provide an independent review of its maintenance programs for both facilities and equipment, a corrective action preventive action (CAPA) plan, and a data integrity remediation strategy that includes a comprehensive investigation into data integrity lapses; a current risk assessment on drug quality; and a management strategy to ensure the reliability and completeness of all data generated by the company.

FDA also noted that it has cited similar cGMP violations at the Ahmedabad facility in a previous warning letter on November 1, 2010.

Source: FDA