FDA 483 - Pd Products Llc - January 30, 2025

An FDA inspection of Pd Products Llc, a medical device manufacturer in West Hills, CA, occurred from January 28 to January 30, 2025. Investigator Sarah A Hassas issued a Form FDA-483, detailing significant observations concerning the company's quality management system. The main issue was the lack of established quality system procedures and instructions. Specifically, the firm, which imports and distributes Class II medical devices (External Penile Rigidity Devices), failed to implement essential procedures for complaint handling, including a formally designated unit for receiving and evaluating complaints. Additionally, a Medical Device Reporting (MDR) procedure was absent, hindering the timely identification and evaluation of reportable events. This deficiency highlights non-compliance with the regulatory framework governing medical device manufacturing. The FDA-483 serves as an initial observation, emphasizing the firm's responsibility under the Federal Food, Drug, and Cosmetic Act to conduct internal audits and correct all quality system violations. Pd Products Llc has committed to addressing the noted observations.