Carrashield Labs Inc. – FDA 483, Apr 29, 2026

An FDA inspection of Carrashield, Labs Inc. in Saint Petersburg, FL, revealed three significant observations related to their quality system for medical devices. The firm failed to adequately implement risk management outputs into design inputs, did not perform or document design verification for labeling changes, and lacked unique device identifiers (UDI) on their Divine 9 personal lubricant device labels. These issues indicate deficiencies in design control and labeling compliance.