Assay Importer Notified Over Supplier Controls, Complaints

September 23, 2016

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 reaudits of deficient areas. Tosoh’s manager of regulatory affairs and quality assurance told the FDA investigator that it does not perform re-audits.

Outside Audit Needed

The FDA requested the company submit an audit certification from an outside expert, along with a copy of the consultant’s report and assurance that Tosoh has initiated or completed any recommendations. The agency also asked the company to schedule a regulatory meeting to discuss the issues and a corrective action plan.

In addition to supplier control and audit problems, Tosoh was chided on its complaint handling. For example, it didn’t treat service calls for analyzers under warranty as complaints, despite being defined as such by its procedures. Complaints on “consumable” products such as needles, cups, and analyzer accessory kits were not analyzed to identify existing and potential causes of quality problems.

The company’s complaint-handling procedure did not ensure that all complaints are reviewed and investigated, the letter notes. The FDA investigator looked at more than 15 non-routine service reports related to possible failures of analyzers, but the complaint section in the company’s database was not filled out for these issues. No investigation form was initiated.

Failure to analyze trends and nonconformance was also cited, with the investigator noting that not all sources of quality data are being analyzed. For example, leaking bottles found during manufacturing and service complaint ticket reports opened as “warranty” were not analyzed to identify existing and potential causes of quality problems.

Inappropriate Methodology

“You have not identified appropriate statistical methodology ... to detect recurring quality problems,” the letter says. It points out that Tosoh’s trending procedure only applies to devices with an installed base of 100 or more units. Service and complaints received on some analyzers were not analyzed because there were less than 100 units in distribution.

Additionally, information in certain sections of one of Tosoh’s databases is not standardized and the “type” is not always entered, so the failure rate per part cannot be calculated accurately, the letter says. “As a result, you are not identifying failure rates per part that are above your thresholds for initiating a CAPA.”

One citation noted that Tosoh found a problem exceeded its failure rate tolerance for a product but it did not initiate a corrective action request form. It also failed to verify and validate CAPAs to ensure they are effective and do not negatively affect the device.

The warning letter goes on to cite preventive maintenance issues, noting that Tosoh’s schedule requires the main warehouse refrigerator to be inspected quarterly, but there were no forms/ records of inspections for 2016, it says.

The company did not respond to a request for comment by press time.

Devicemakers are outsourcing more and more of their critical operations and materials, trying to wring out costs and improve their profitability. Today’s minor mistake by your supplier could easily turn into tomorrow’s major recall. And if you don’t catch all the oversights in your quality agreement, odds are the FDA will. Order 24 Elements of a Successful Supplier Quality Agreement to make sure you’ve covered all your bases and keep your suppliers well in hand.

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