Nira Innovations, Inc. – FDA 483, Jul 18, 2019

DERMAL PHOTONICS CORPORATION in Peabody, MA, a medical device manufacturer, was cited for significant deficiencies in its design control procedures. The inspection revealed a lack of established procedures for design output and design transfer, as well as inadequate documentation of design verification results for its Nira Laser product. These issues indicate a moderate level of non-compliance with quality system regulations.