Poor Supplier Controls Prompt 483 for Fluke Biomedical

Fluke Biomedical was handed a five-observation Form 483 because it failed to properly select any of the suppliers for its CLEAR-Pb X-Ray shielding products.

The Cincinnati-based company’s supplier assessment request form — used to qualify suppliers — does not require quality system information to evaluate their ability, according to the Feb. 9 Form 483. Four out of the five suppliers had no certification, such as ISO, and no documented evidence of an adequate quality system. Additionally, Fluke did not determine whether they validate and monitor processes for manufacturing Fluke’s components.

According to the purchasing procedure, if a supplier has a quality rating of less than 80 percent for three months in a row, Fluke must review the nonconformities, conduct evaluations, share the results with the supplier and open a supplier corrective action. The company gave an unacceptable rating to one of its suppliers since at least March 2015, but there was no evidence of supplier communications or a supplier corrective action request. — Tamra Sami