The US Food and Drug Administration (FDA) has issued a Warning Letter to Baxter International for its drug-manufacturing facility in Ahmedabad, India over violations of cGMP regulations for finished pharmaceuticals. Baxter acquired the plant in 2017 as part of its $625-million acquisition of Claris Injectables, an Ahmedabad-based generic injectables pharmaceutical company.
The FDA inspected the drug manufacturing facility from July 27, 2017 to August 4, 2017 with the inspection beginning the day Baxter announced the completion of its acquisition of Claris.
In the Warning Letter, the FDA cited Claris for concluding its investigations of out-of-specification (OOS) results despite a lack of sufficient evidence and failing to investigate container-closure system failures. The FDA has asked that the company to provide a review of all invalidated OOS results obtained for products on the US market and a summary report of the review of all OOS investigations for products remaining within the expiry with a corrective and preventative action (CAPA) plan. The FDA also requested a fully remediated OOS investigation procedure and an updated investigation into the root cause of container-closure system failures.
The FDA also cited that an operator at Claris recorded unreliable data and noted that a senior manager could not provide an explanation for how portions of a visual-inspection test document had been completed without corresponding data. The FDA has requested that the company provide a risk assessment of production records to determine the completeness, consistency, and accuracy of reported data as well as a complete assessment of documentation systems used throughout the company’s manufacturing and laboratory operations to determine where documentation practices are insufficient.
The FDA further cited the company after observing evidence of water damage in the facility, including warped ceiling panels, puddles of water, and water stains. The FDA has asked that the company provide a review of the company’s preventive maintenance program(s) for both facilities and equipment, and a CAPA plan. The FDA also requested a CAPA plan that formalizes production-management oversight of facility conditions, a plan to monitor and control humidity levels in the facility, and a plan to requalify the facility after remediating the water damage.
The FDA says it cited similar cGMP violations in a previous warning letter in November 2010.