FDA Cites Dental Syringe Maker for Numerous GMP Violations

Sci-Dent received a warning letter citing it for 13 good manufacturing practice (GMP) violations and for making a variety of aspirating dental injection syringes without FDA approval or clearance. During a July inspection of the company’s Hamburg, N.Y., facility, FDA investigators found no procedures to control the design of the syringes produced since 2004. Sci-Dent changed their design but had no data or documentation to support the verification, review and approval of the change, according to the Nov. 10 letter posted recently to the FDA website.
The GMP Letter