The FDA made public this week a warning letter that it sent to a Claris Injectables pharmaceutical manufacturing site earlier this month.
Baxter (NYSE:BAX) acquired the Ahmedabad, India-based facility in its $625 million purchase of Claris Lifesciences‘ (BOM:533288) injectable drug business. The FDA noted that the site has twice invalidated out-of-specification results without thoroughly investigating the matter.
The U.S. regulatory agency also pointed out that the facility is linked to a “worrisome history” of recalls, including a Class I recall in 2010 of four drugs due in part to non-sterility.
Among other problems noted at the site, the FDA wrote in its letter that investigators observed evidence of water damage inside the facility, including puddles of water and warped ceiling panels.
“It is essential that your plant management maintains the facility in a good state of repair to ensure ongoing suitability for drug manufacturing,” the FDA wrote.
Baxter told Regulatory Focus that it assumed control of the site on July 27, 2017 – hours after the FDA began its inspection – and that the company received the agency’s findings just one week after the Claris buyout closed.
Although Baxter told the news site that it already put corrective actions in place at the manufacturing site, the company added that it is “committed to completing the full integration of the Ahmedabad facility into our quality systems and any other items needed to fully address the Claris warning letter.”
