# FDA 483 - RMG ART Laboratories, LLC - July 12, 2019

Source: https://www.keypedia.com/records/483/rmg-art-laboratories-llc/1ea7dd01-b96f-4e47-a077-8227925dc27f

> FDA 483 for RMG ART Laboratories, LLC on July 12, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RMG ART Laboratories, LLC
- Inspection Date: 2019-07-12
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: RMA ART Laboratories, Inc. in Temple Terrace, FL, was cited for significant deficiencies in the labeling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The inspection revealed that reproductive tissues from ineligible donors and those from sexually intimate partners, for which donor eligibility was not determined, lacked required biohazard legends and warnings regarding communicable disease risks. These issues indicate a failure to properly identify and label HCT/Ps with potential health risks to recipients.

## Related Officers

- [investigator](https://www.keypedia.com/people/samantha-j-pinizzotto/296e8763-39e9-4b6d-9b89-661322d5a53c)

Company: https://www.keypedia.com/companies/rmg-art-laboratories-llc/39374d18-91e0-43b0-8a53-64db46238ef0

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6