# FDA 483 - Biomedical Regenerative GF, LLC - May 30, 2023

Source: https://www.keypedia.com/records/483/biomedical-regenerative-gf-llc/569ae9b2-a104-4143-a163-f4176a72d109

> FDA 483 for Biomedical Regenerative GF, LLC on May 30, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomedical Regenerative GF, LLC
- Inspection Date: 2023-05-30
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Biomedical Regenerative GF, LLC in Boca Raton, FL, was inspected and received a Form FDA 483 with six observations. The inspection revealed significant deficiencies in the firm's quality system, including failures in risk management, design control, medical device reporting, device master records, management representation, and document control. These issues indicate a lack of established and maintained procedures critical for ensuring product quality and regulatory compliance.

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