FDA 483 - Naked Int'l Inc - September 23, 2023

An FDA inspection of Naked Int'l Inc., a specification developer of condoms, was conducted from September 14 to September 26, 2023. The inspection, documented in an FDA Form 483, identified several significant deficiencies in the company's quality management system, indicating non-compliance with federal quality system regulations for medical devices.Major violations included the failure to establish a design history file for condom design control. The firm also lacked a system for maintaining complaint files and a procedure for handling customer complaints. Furthermore, Naked Int'l Inc. had not established requirements for its suppliers and contractors, specifically failing to implement quality agreements or conduct vendor evaluations for its contract manufacturer. Lastly, the company had not documented any corrective and preventive action (CAPA) activities or results, nor had it established a CAPA procedure.In response to these observations, Naked Int'l Inc. committed to correcting each identified issue. These actions are crucial for the company to achieve and maintain compliance with established quality system requirements, ultimately ensuring the safety and effectiveness of its products.