FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Leventon Hit for Failing to Document Design Changes

Nov. 6, 2018
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Spanish devicemaker Leventon received a warning letter after the agency’s March 19-22 inspection revealed the firm failed to confirm its device products conformed to specifications.

For example, the firm checked its Dosi Fuser product — a chemotherapy continuous infusion device — to ensure it provides an expected flow rate. However, it had no procedure in place explaining how to conduct the analysis, and did not tell the agency it planned to train employees on how to properly conduct it.

The company also didn’t record all design changes properly. One of its change documents, which summarized a new product for the U.S. market, had a design verification record that showed the device didn’t meet its required infusion delivery time.

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