The U.S. FDA last month issued a warning letter to Arnold Tuber Industries -- doing business as Sci-Dent -- for making aspirating dental injection syringes without proper FDA clearance.
During a July inspection of the company's facility in Hamburg, NY, FDA investigators found no procedures to control the design of the syringes, according to the letter. Sci-Dent reportedly changed its syringe design but had no data or documentation to support FDA verification, review, and approval of the change, the FDA said.
The agency also cited Sci-Dent for 13 good manufacturing practice violations.
