WASHINGTON (Reuters) - U.S. health regulators have warned Bristol Myers Squibb Co over repeated manufacturing violations at its facility in Puerto Rico and said future drug approvals could be at risk, according to a letter released on Tuesday.
The problems, which include failures to take steps to prevent contamination or investigate subpar drug batches, show inherent weakness with the company’s quality controls, the Food and Drug Administration said in a letter to Bristol Chairman and Chief Executive Jim Cornelius.
Such violations could put any pending new drugs on hold until the problems are corrected, the agency wrote.
After the letter, shares of Bristol were off about 1 percent, or 29 cents, at $26.91 in midday trading on the New York Stock Exchange.
Sonia Choi, a spokeswoman for Bristol, said the Puerto Rican plant makes at least eight products, including certain versions of antipsychotic Abilify and rheumatoid arthritis drug Orencia, and that the company took the FDA’s concerns seriously.
“We’re working with FDA to promptly address the issue,” she told Reuters.
The FDA’s warning follows a March 2010 inspection of the drugmaker’s Manati, Puerto Rico, plant that found plant workers did not comply with practices to keep areas sterile. Similar problems were also found in 2005 and 2009, the agency wrote.
The inspection also turned up failures to check when there were problems with a batch of products, the FDA said. It also turned up problems with Bristol’s plans to test product standards.
While the company responded to the agency’s concerns in April, its response “lacks sufficient corrective actions,” the FDA wrote in its warning letter, dated August 30.
Choi said the company met with the FDA in August before the warning letter was issued and has already taken some steps to fix some of the problems, although she could not say when the violations would be fixed. It will also submit a plan to the FDA outlining how it will correct the problems, she said.
The company is subject to additional inspections, the FDA said. The agency called on the drugmaker to hire an outside company to help improve the facility and its procedures, something Choi said the company has done.
Bristol has received at least a half-dozen letters from the FDA for various violations since 1998, according to the FDA’s website.
A copy of the letter released Tuesday is at link.reuters.com/bug53p.
Reporting by Susan Heavey. Editing by Robert MacMillan