# FDA 483 - Hiossen, Inc - July 23, 2025

Source: https://www.keypedia.com/records/483/hiossen-inc/9bbe0e58-27e2-43ca-be4a-ec81522e9b69

> FDA 483 for Hiossen, Inc on July 23, 2025. Product: devices. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Hiossen, Inc
- Inspection Date: 2025-07-23
- Product Type: devices
- Office Name: Philadelphia District Office
- Summary: An FDA Form 483 was issued following an inspection conducted from July 22-23, 2025, at a medical device manufacturing facility located in Fairless Hills, PA 19030. The report was addressed to Peter Lee, the Director and Quality Management Representative for the firm, whose specific name was not provided in the document. The central observation during the inspection related to the firm's adherence to Medical Device Reporting (MDR) requirements. It was noted that the company did not submit MDR reports within the regulatory 30-day period after becoming aware of information indicating that marketed dental implants had malfunctioned, with a likelihood of causing or contributing to death or serious injury if the malfunction recurred. Three specific instances were cited where malfunction-related complaints from September 2023 were only reported via MEDWATCH in November 2023, thereby missing the stipulated reporting deadline. This finding underscores the regulatory mandate under the Federal Food, Drug, and Cosmetic Act for timely reporting of adverse events associated with medical devices, crucial for safeguarding public health. Notably, an annotation within the FDA 483 document indicates that this specific observation, regarding the delayed MDR submissions, was subsequently 'Corrected and verified,' suggesting the firm has taken action to resolve the identified compliance issue.

## Related Officers

- [Investigator at US Food and Drug Administration](https://www.keypedia.com/people/brian-s-keefer/4fec578b-ca72-4d79-8634-3a9fe7ecd9a5)

Company: https://www.keypedia.com/companies/hiossen-inc/54e2eabd-a117-4c32-b75d-56956ffcca5c

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8