Diagnostic test maker Tosoh Bioscience Inc. has received a warning letter from the Food & Drug Administration over record-keeping violations and failing to follow industry manufacturing standards at its Grove City, Ohio, plant.
Among Tosoh’s violations cited by the FDA was the “misbranding” of a diabetes test. The FDA said Tosoh didn’t notify the agency of its intention to introduce the device to commercial distribution.
Additionally, the FDA cited nine examples of failure to follow FDA regulations surrounding “good manufacturing practices.” Those include failing to investigate complaints of problems with devices, to establish procedures to take corrective and preventive actions, to control and monitor production processes and to ensure equipment is routinely calibrated.
Tosoh spokesman didn’t respond to a request for comment.
Tosoh Bioscience is headquartered in South San Francisco, Calif. Its parent company, Tosoh Corp., was founded in 1935 and is based in Tokyo. The company sells its clinical diagnostic products to hospital, reference and physician office laboratories.
The violations were uncovered in inspections of Tosoh’s Grove City facility in the spring of 2010.
The company was instructed to correct its violations promptly and write to the FDA within 15 days describing the corrective actions it took. The letter was dated Jan. 18, and published on the FDA’s website today.
Warning letters generally are considered by the FDA to be informal and advisory. The letters are a fairly routine part of doing business for medical device firms.