In yet another crackdown on manufacturing violations, the FDA has cited Bristol-Myers Squibb for repeated problems at a plant in Puerto Rico. The plant makes at least eight products, including formulations of the antipsychotic drug Abilify and anti-inflammatory drug Orencia. Until its problems are fixed, the FDA says in a warning letter, any pending BMS drug approvals could be put on hold.
According to the letter, plant workers didn't comply with procedures designed to keep areas sterile and didn't properly investigate problem batches of drugs. FDA inspectors found similar problems in 2005 and 2009, and it's that repetition that particularly ticked off the agency. "Repeat citations from prior inspections indicate that your quality control unit is either not appropriately exercising its responsibilities or does not have the authority to carry out its responsibilities," the agency says in its letter.
When BMS responded in April to the FDA's concerns about the plant, the company didn't propose "sufficient corrective actions," the agency says. Since then, a BMS spokeswoman tells Reuters, the company has met with FDA about the problems and has already taken some steps to fix them. At the agency's suggestion, BMS has hired an outside company to help bring the facility up to snuff. BMS will submit a plan for corrective action to the FDA, the spokeswoman says. Meanwhile, the FDA will be keeping a close eye on BMS; the letter warns that the company is now subject to additional inspections.
The warning letter echoes those issued for other recent manufacturing violations. The FDA has stepped up inspections and called on other drugmakers, including Johnson & Johnson, to get outside help with fixing their manufacturing woes.