FDA 483 - PD Products Llc - January 30, 2025

The Food and Drug Administration (FDA) conducted an inspection of Pd Products Llc, a medical device manufacturer and distributor of Class II External Penile Rigidity Devices, from January 28 to January 30, 2025. The inspection resulted in the issuance of a Form FDA-483, identifying significant deficiencies in the company's quality management system. The primary observation noted was the absence of established quality system procedures and instructions. Specifically, Pd Products Llc lacked a formal Complaint Procedure for the proper receipt, review, and evaluation of complaints, and a Medical Device Reporting Procedure for the timely identification and assessment of reportable events. These issues indicate non-compliance with fundamental quality system requirements for medical devices, which are essential for ensuring product safety and effectiveness. While the FDA-483 is not a final determination, it requires the firm to address these observations. Pd Products Llc verbally committed to correcting the identified deficiencies, and is responsible for implementing comprehensive corrective actions to comply with regulatory standards.