Bristol-Myers: FDA wants factory’s problems fixed

TRENTON, N.J. (AP) — U.S. regulators have told drugmaker Bristol-Myers Squibb Co. they won’t approve an important new drug until the company fixes multiple deficiencies at its Puerto Rico manufacturing plant, the company’s CEO disclosed Tuesday.

The problems, including glass particles in drug vials and possible contamination of sterile drug products, are disclosed in an Aug. 30 warning letter sent to the company by the Food and Drug Administration.

Bristol-Myers Chief Executive Lamberto Andreotti gave an update on the problems at its Manati factory Tuesday during a conference call with analysts about Bristol’s third-quarter results.

He said Bristol-Myers is “taking all the actions that we think we need to take,” including hiring a manufacturing consultant to help.

“We expect that the Manati facility will be inspection-ready by the end of the year,” Andreotti said. “Manufacturing continues uninterrupted in Manati.”

He said the New York-based company must resolve the problems there before the FDA will approve sales of belatacept, a new biologic drug to prevent rejection of transplanted organs.

The FDA’s letter states that unless the violations cited are promptly corrected, FDA could take actions including seizing products made there, withholding approval to export products from there and withholding approval of new drugs that would be made at the facility.

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