FDA defines "fix zone" for BMS aseptic fill violations

Promising daily monitoring of plant workers' aseptic procedures was not enough to satisfy the FDA that Bristol-Myers Squibb has the persistent problem resolved. "Please provide more information on the extent of this supervision," says Warning Letter 10-SJN-WL-06, addressed to BMS chairman and CEO Jim Cornelius. The regulator finds repeated failure of aseptic operators to follow procedures while working in a Class 100 filling operation.

The letter references the March inspection of a Puerto Rico manufacturing facility and the company's response of April 14, which the regulator says lacks sufficient corrective actions. BMS said that existing aseptic SOPs are "inadequate" and not actual practice. The company promised to revise the procedures.

Nonetheless, "it is FDA's expectation that your firm promptly correct all deficient procedures to ensure employees do not continue improper practices," says the warning letter.

The plant houses operations for at least eight products, among them the antipsychotic Abilify and anti-inflammatory Orencia. The FDA details its expectations regarding both acceptable and unacceptable fixes. And it leaves the drugmaker little wiggle room.

"Use of a log book to document supervisory observation of the aseptic filling process does not provide assurance of adequate supervision," the letter states. "Please provide a plan that evaluates your training program, specifically the program's effectiveness and your assurances of personnel compliance to aseptic processes prior to certification to work in an aseptic area."

- see the BMS warning letter