Today’s must-read: FDA warns Abbott Diabetes Care on quality control issues
Today brings a piece from MassDevice saying the federal Food & Drug Administration sent a warning letter to Abbott Diabetes Care claiming its inspectors found problems with the quality control and inspection processes at the company’s Alameda plant.
The July 2 letter, which is available with the story, cited incidents where empty blister packs and scratched glucose test strips were found at the plant, which produces Abbott’s FreeStyle glucose monitoring and Navigator continuous monitoring systems, the publication said.
Some of the company’s workers were found to lack the proper background, education, training and experience for their jobs, including the plant’s director of quality systems, its regulatory affairs manager and its quality control supervisor, the publication said.
The company had responded to the agency regarding its findings, but the agency wasn’t convinced corrections to the issues it raised had been made.
The company had 15 working days from the issuance of the letter to correct the problems, or face regulatory action without notice, the publication said.