FDA warning letter nails 2 Baxter plants for repeat violations

Baxter International ($BAX) has poured money into upgrades and changes to plants in Puerto Rico named in FDA warning letters two years ago. But Baxter's plant in Jayuya, Puerto Rico, has been cited again, along with a plant in Marion, NC, where inspectors noted mold in the filling area. The FDA said both facilities have yet to get on top of problems observed in earlier visits.

In a statement to FiercePharmaManufacturing, the company said it was responding to FDA concerns and that it already is making improvements, including adding real-time environmental controls. "Baxter is committed to maintaining the highest standards of quality and safety for our patients," the company said.

Inspectors, however, were not very impressed with Baxter's commitment to quality during the inspections in November, March and April. They found mold in HEPA filters throughout the sterile filling area at the Marion plant. According to the May 31 letter, the FDA was bothered that Baxter officials downplayed the potential problems from the mold by saying the products were "terminally sanitized." The letter also said that while Baxter stopped its large-volume parenteral line and release of products to deal with the mold, it never figured out what the root cause was that allowed it to grow "to a level of TNTC (Too Numerous to Count)." Without knowing the root cause, there is no assurance the problem is resolved, the agency said. Further, it said, the company's "environmental monitoring program was insufficient to detect contamination of concern, including mold observed on the clean side of the air filters supplying air to the sterile filling areas."

The letter also said the plant was not thoroughly cleaning its equipment and not fully investigating the source of the mold, both repeats of violations noted during an August inspection. In Puerto Rico, inspectors criticized how the company handled problems with leaky bags. Problems with the bags were blamed on a supplier. Those Baxter still had on hand were trashed, but at least 27 lots potentially affected were already in the market. Baxter decided that a cap on the bag would protect the sterility of the drug even if membranes leaked, but the FDA said the company then got complaints of poorly fitting caps. It recalled the products only after the agency pointed out the potential for problems.

In addition, inspectors said Baxter reported 20 nonconformance reports on liquid products containing everything from skin to human hair to rayon and that there was no indication that its processes were sound enough to prevent the problem on an ongoing basis. The FDA said the fact that Baxter did not thoroughly investigate the leaky bags and the particles were the same kinds of issues that had been noted in the 2011 warning. That warning had been directed at the Jayuya plant, as well as one in Guayama, PR.

Baxter has spent millions to make improvements at its plants in Puerto Rico, including a reported $35 million shared on the Jayuya plant and one in Aibonito. Upgrades to make the Aibonito injectable drug facility more efficient are leading to about 400 job cuts.

- here's the warning letter