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FDAnews Device Daily Bulletin

GFS Chemicals Cited for Complaints, Records

Aug. 11, 2017

An Ohio contract manufacturer of medical devices failed to maintain adequate records for its manufacturing processes, failed to set requirements for suppliers and lacked procedures for conducting quality audits or handling complaints, the FDA said.

The company, GFS Chemicals, of Columbus, sells laboratory equipment and chemicals to a variety of customers, including pharmaceutical firms.

The FDA reviewed the facility’s production processes and protocols going back 10 years in an inspection conducted in March, and found the company’s device history records were incomplete and showed the facility failed to follow its manufacturing procedures.

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