The U.S. Food and Drug Administration has warned Abbott Laboratories’ diabetes care unit about manufacturing problems at its Alameda, California plant, a letter released Tuesday said.
In a letter dated July 2, FDA said its inspectors found Abbott’s Freestyle and Navigator blood glucose monitoring products were adulturated and not conforming with codes for good quality system manufacturing practices.
“The letter relates to our corrective and preventative measures and some of our internal validation and documentation procedures,” Abbott spokesman Greg Miley said.
The warning does not affect the availability of those products, he said.
FDA, in the letter, said the company had failed to address the manufacture of empty blister packs and finding of scratches on FreeStyle Lite test strips.
The letter also cited the diabetes care unit for failing to establish and maintain adequate procedures for validating device design.
“Abbott Diabetes Care has taken and continues to take actions necessary to address the items outlined in the letter, and is communicating those actions directly to the agency,” Miley said.
Failure to promptly correct the violations may result in further regulatory action, FDA said.
Shares of Abbott rose 4 cents to $47.45 in late-afternoon trading on the New York Stock Exchange.
