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Wheelchair Maker Gets Warning Noting Supplier, Audit Issues

December 2, 2010
The Standing Co., a manufacturer of stand-up wheelchairs, has received a warning letter noting its failure to evaluate certain wheel, brake and joystick controller suppliers for their ability to meet specifications. The letter also points out problems with the company’s self-evaluations. For example, findings from internal audits conducted Feb. 12 and Sept. 3, 2009, were not addressed as corrective actions. The Saginaw, Mich., company also does not analyze quality data sources at regular intervals to identify causes of nonconforming product or other quality problems that may require a corrective or preventive action, according to the letter.
The GMP Letter