FDA 483 - Nutraluxe Global, LLC #1 - March 15, 2019

Pulsaderm, LLC, a medical device manufacturer in Fort Myers, FL, received a Form FDA-483 with four observations during an inspection. The firm was cited for deficiencies in its quality system, specifically regarding complaint handling, corrective and preventive actions, design validation, and document control. These issues indicate a need for significant improvements in the firm's procedural adherence and record-keeping practices.