FDA 483 - Good Clean Love, Inc. - June 13, 2019

Good Clean Love, Inc., a manufacturer of the BioNude Ultra Sensitive Personal Lubricant (a Class 2 medical device), was cited for three observations during an FDA inspection. The firm failed to perform a required risk analysis for the BioNude device, lacked adequate procedures for evaluating design changes for regulatory impact, and did not properly maintain its device master record with correct product specifications. These issues indicate deficiencies in the firm's quality system for medical device development and control.