Devicemaker Warned on Averaging Supplier Quality, Delivery Ratings

October 31, 2014

Western Enterprises/Scott Fetzer Company received an FDA warning letter after averaging its suppliers’ quality ratings with its delivery ratings, resulting in a higher overall rating for some suppliers.

The practice means a supplier’s quality rating could be as low as 60 percent and still be acceptable, according to the Oct. 10 warning letter published recently online.

In August 2013, one supplier’s quality rating was 66.7 percent, but its delivery rating was 100 percent, making its overall rating for the month 83.3 percent. This is considered acceptable by the company, the letter says, adding “no further action was taken regarding the quality issues with this supplier.”

The Westlake, Ohio, company makes medical gas pressure regulators and suction regulators.

Western also failed to investigate suction regulator bodies that were received from a supplier with “dents and dings that can cause leakage when assembled.” No supplier corrective action request was issued and “the regulators were just returned to the supplier,” the letter says.

The warning letter followed a July 10 through Sept. 2 inspection by the FDA’s Cincinnati district office.

Several of Western’s suppliers lacked a self-survey or current registration certification, which the company’s procedure requires. Meanwhile, the firm did not treat test labs and consultants as suppliers, as required by the procedure. “As a result, you have not ensured the received services conform to specified requirements,” the warning letter says.

The FDA also critiqued the company’s customer complaint procedure. On April 21, Western learned of a complaint involving an “ignition” event with a medical gas pressure regulator that it contract manufactures. However, the information wasn’t entered into the complaint system until July 25, during the inspection.

The procedure also fails to address reviews and updates to product risk analyses based on postmarket data. For example, the three risk analyses for the OxyTOTE regulators weren’t updated after the complaint involving the ignition event.

The failure investigation for that complaint was deemed inadequate as well. An outside laboratory performed the investigation and recommended further chemical and/or metallurgical analysis to shed light on the origin, ignition mechanisms and propagation characteristics. But “you closed this complaint without any further testing and there was no documented rationale as to why this testing was not needed,” the letter says.

The more suppliers you have, the more opportunities you give the FDA to find fault with your operations. Prevent warning letters by purchasing Device Supplier Controls.