1.26.11 | Brandon Glenn

Tosoh Bioscience gets FDA warning letter for manufacturing violations

Diagnostic test maker Tosoh Bioscience has received an FDA warning letter over record-keeping violations and failing to follow industry manufacturing standards at its Grove City, Ohio, location.

Among Tosoh’s violations cited by the U.S. Food and Drug Administration 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.

A Tosoh spokesman didn’t respond to a request for comment.

Tosoh Bioscience is headquartered in South San Francisco, California. 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. Grove City is a suburb of Columbus.

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.

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Brandon Glenn MedCity News

Brandon Glenn is the Ohio bureau chief for MedCity News.

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Tags: California, Columbus, medical devices, Ohio, Tosoh Bioscience, U.S. Food and Drug Administration

Comments Post a comment

“Warning letters generally are considered by the FDA to be informal and advisory.”

You’re misinformed. A Warning Letter is a formal legal shot-across-the-bow. It’s the last step before the FDA takes legal action, or blocks imports and US government contracts if that step is available, or shows up at the door with US Marshalls.

“The letters are a fairly routine part of doing business for medical device firms.”

Warning letters are only “routine” for companies that regard quality and rules compliance as cost-sinks, to be achieved only to the extent necessary to avoid being shut down.

Comment by JWilly48519 — January 27, 2011 @ 9:34 am