Assay Importer Receives FDA Warning Over Supplier Controls, Complaints

Tosoh Bioscience, an importer of assays and high performance liquid chromatographs, failed to properly manage its suppliers and handle complaints, according to an FDA warning letter.

The company’s Grove City, Ohio, facility didn’t describe quality requirements for its three supplier risk levels in its procedures for supplier quality system reviews and on-site audits, according to the Aug. 5 letter.

Its 2016 supplier review did not ensure that suppliers were adequately evaluated and monitored, the letter adds. “Tosoh has received complaints on two of the 11 suppliers reviewed by the FDA investigator.” However, its “2016 review of these two suppliers stated ‘no recorded complaints.’”

Meanwhile, its procedure for quality system audits and auditor training did not discuss re-audits of deficient areas. Tosoh’s manager of regulatory affairs and quality assurance told the FDA investigator that it does not perform re-audits.

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