FDA nails Baxter with warning letter for plant picked up in Claris buyout

Baxter saline
The Claris Injectables plant in India now owned by Baxter has had a history of recalls, the FDA said in a warning letter. (Baxter)

At exactly the same time that Baxter International was closing its $625 million deal for Claris Injectables last year, FDA inspectors were taking a hard look at one of the three plants Baxter had acquired. Turns out they were not very impressed with its manufacturing processes.

The FDA Tuesday posted a warning letter for a Claris plant in Ahmedabad that was issued earlier this month. The warning noted that Claris, before Baxter bought it out, “has had a worrisome history of recalls due to substandard” products which Baxter has yet to resolve. Many of those had to do with container closures.

The FDA said the plant had too often failed to expand out-of-specification investigations in a timely fashion to look into potential manufacturing causes and had accepted “passing results from testing a new set of samples based on an unproven hypothesis was insufficient to conclude the investigations.”

In an emailed comment, Baxter said, "As a reminder, we assumed control of the Claris Injectables facility on July 27, 2017 (hours after the start of FDA’s inspection) and received the results of the FDA inspection within approximately one week of the acquisition’s close. The Claris warning letter notes that 'FDA is aware that Baxter acquired this facility the same day the inspection started.'"

RELATED: Baxter to expand 3 plants it picked up in Claris Injectables buyout

It said the company "is committed to fully implementing corrective and preventive actions to address FDA’s observations associated with the former Claris Injectables site."

The Deerfield, Illinois-based specialist in sterile injectable drugs last year completed its $625 million deal for the Indian company, which includes three manufacturing facilities—one of which the FDA approved—along with a portfolio of approved drugs and a pipeline of potential new products.

Baxter said at the time that it would begin adding both capacity and new technologies to the plants, including new aseptic manufacturing and lyophilization and new technology platforms in areas like cytotoxics, aseptic development and complex formulations. It also will add to Claris’ R&D capabilities to increase and accelerate its pipeline output.

“The combination of Baxter and Claris Injectables will allow us to increase access to lower-cost generic injectables and strengthen our ability to meet the needs of healthcare providers and patients around the world,” CEO Joe Almeida said in a statement.

The addition of Claris added about 50 products to Baxter’s portfolio in 2017, almost 20 more than in 2018 and 2019 combined, and a stream of 10-15 new products per year beginning in 2020.