# FDA 483 - Pd Products Llc - January 30, 2025

Source: https://www.keypedia.com/records/483/pd-products-llc/1ec6ca51-8aa9-40a4-90b7-692a0ac22169

> FDA 483 for Pd Products Llc on January 30, 2025. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pd Products Llc
- Inspection Date: 2025-01-30
- Product Type: devices
- Office Name: Los Angeles District Office
- Summary: The U.S. Food and Drug Administration (FDA) issued a Form FDA-483 to Pd Products Llc following an inspection conducted from January 28 to January 30, 2025, at their West Hills, CA facility. The inspection identified significant issues concerning the company's quality management system for medical devices. The primary observation noted was the absence of established quality system procedures and instructions. As an importer and distributor of Class II medical devices, specifically External Penile Rigidity Devices, Pd Products Llc is required to maintain a robust quality system under federal regulations to ensure product safety and effectiveness. Specifically, the FDA investigator observed a lack of a formal Complaint Procedure for receiving, reviewing, and evaluating customer feedback and potential issues. Furthermore, the company had not implemented a Medical Device Reporting Procedure, which is crucial for the timely identification, communication, and evaluation of adverse events that may be subject to mandatory reporting requirements to the FDA. These observations indicate a fundamental gap in compliance with the regulatory framework for medical device quality systems. While the document notes a promise to correct, Pd Products Llc is now responsible for promptly addressing these deficiencies by developing and implementing the necessary quality system procedures to ensure adherence to federal regulations and maintain appropriate control over their medical device operations.

## Related Officers

- [investigator](https://www.keypedia.com/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.keypedia.com/companies/pd-products-llc/4c2ceb5d-b46f-4646-9ab4-e8be011c8c7b

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b