The FDA has warned Miami-based Trucare Biomedix-USA over slips on supplier audits, purchasing controls and other good manufacturing practices.

According to the Nov. 24 warning letter posted, the company stated on its website that suppliers are audited each quarter. However, during the inspection, Trucare’s president said that information was not accurate.

Trucare is a specification developer, distributor and importer of IV administration sets and an importer/own label distributor of IV poles and syringes. But its purchasing control procedures don’t ensure that suppliers have adequate quality control programs, including personnel qualification for bonding, process validation of special and automated processes and equipment maintenance, the warning letter says.

While the company has documentation from its current IV administration set contractor on sterilization validation, package integrity validation and certificates of analysis and sterilization, its purchasing control procedures don’t require these documents for potential future suppliers, the FDA investigator found. The letter follows a Sept. 11-17 inspection of Trucare’s South Miami facility.

The investigator further noted that Trucare’s internal audit SOP requires it to generate an audit schedule and cover all major systems and areas at least once a year. However, the company has no documented schedule and no documented internal audit criteria and had not completed any official internal audits, the letter notes.

The company’s CAPA procedures also came under fire for lacking requirements to verify or validate CAPAs and for not including definitions of preventive actions or instructions regarding how preventive actions will be controlled.

A 2012 CAPA addressing three complaints about leaky IV administration sets, which had the potential to harm patients, was deemed inadequate by the FDA. The CAPA said that the contractor responsible for the manual bonding defect was removed from the accepted supplier list; however, it failed to assure that purchasing control procedures were changed to prevent a similar incident in the future.

The company now requires its contractor to conduct 100 percent leak testing for IV administration sets, but this requirement has not been documented as part of written purchasing control procedures, the warning letter says.

Other citations state that:

• The company could not provide the FDA investigator with an English translation of a risk analysis that was documented in Spanish;
• Document control procedures don’t specify how the company will control draft or obsolete documents; and
• Trucare lacked written MDR procedures and failed to report three complaints related to a 2012 recall as MDR malfunction reports.

As part of the recall, the company had trucks pick up leaking IV administration sets from various sites — an action the FDA determined is a Class II recall, which should have been reported within 10 days. However, the company didn’t notify the agency within that time frame, the letter says.

The FDA notes that a follow-up inspection may be needed to assess the company’s corrective actions.

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