FDA Warns Aros Surgical on Quality, Marketing

The Food and Drug Administration warned a California-based surgical instrument maker that its products are adulterated and misbranded due to quality violations and lack of marketing clearance, according to a letter posted to the agency’s website Oct. 27.

The FDA letter was addressed to Aros Surgical Instruments Corp. of Newport Beach, Calif., but the letter also calls the company AROSurgical. The letter, signed by Alonza E. Cruse, director of the FDA’s Los Angeles district, listed eight categories of violations that FDA inspectors found during an inspection at a facility in February.

The Sept. 25 letter said that the company didn’t ...