# FDA 483 - BroadMaster Biotech Corp. - April 13, 2023

Source: https://www.keypedia.com/records/483/broadmaster-biotech-corp/ea397a3b-27c7-43f7-b9ed-5bf33f250ec2

> FDA 483 for BroadMaster Biotech Corp. on April 13, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BroadMaster Biotech Corp.
- Inspection Date: 2023-04-13
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: BroadMaster Biotech Corp., a medical device manufacturer in Taoyuan City, Taiwan, was inspected by the FDA. The inspection revealed significant deficiencies in their quality system, including inadequate complaint handling procedures and a lack of implemented Medical Device Reporting (MDR) procedures. Additionally, personnel demonstrated unfamiliarity with USFDA regulations for exporting medical devices to the US market, indicating a general lack of compliance with critical regulatory requirements.

## Related Officers

- [Felix J. Marrero](https://www.keypedia.com/people/felix-j-marrero/fe3bf64e-987b-40d9-8a17-754d58e13433)

Company: https://www.keypedia.com/companies/broadmaster-biotech-corp/fb420b84-bca4-484e-a267-5e504ff3cd35

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd