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Medical Devices / Inspections and Audits

FDA Flags Lack of Procedures at Sure-Tech

Dec. 27, 2017

The FDA flagged Sure-Tech Diagnostics’ manufacturing facility in St. Louis, Missouri, over inadequate procedures.

In an October inspection, the agency found that the firm had not established adequate procedures for handling complaints, and had neglected to include all required information in its complaint file as required by its complaint handling procedure.

The investigation also revealed that the firm had failed to complete internal quality audits and to provide evidence that all elements of its quality system were reviewed.

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