Stingray Gets Form 483 for Color Coating Shortcomings

Shortcomings related to color coating processes and controls for Stingray Surgical Product’s forceps and other devices landed a Form 483 for the Florida-based company. During an inspection of the devicemaker’s Boca Raton facility, investigators found Stingray’s validation of coating processes was inadequate. The validation failed to demonstrate consistency because it only included one device.
The GMP Letter