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FDAnews Device Daily Bulletin

FDA Warns Indiana Devicemaker for Validation Failures

Sept. 17, 2019

The FDA issued a warning letter to Polymer Technology Systems — doing business as PTS Diagnostics — arising from an inspection earlier this year of its facility in Indianapolis.

The agency investigators found that the company’s in vitro diagnostics for diagnosis and management of diabetes, heart disease, kidney function and other chronic diseases were adulterated because the facility was not in compliance with current good manufacturing practices.

Problems identified included failure to ensure that a device conformed to specifications, failure to adequately validate a process whose results cannot be fully verified by subsequent inspection and testing, failure to validate or verify design changes, and failure to establish and maintain procedures for corrective and preventive actions.

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