# FDA 483 - Hemarus LLC - November 04, 2022

Source: https://www.keypedia.com/records/483/hemarus-llc/c54fbafa-ffa0-497a-b14b-3817b0e650a7

> FDA 483 for Hemarus LLC on November 04, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hemarus LLC
- Inspection Date: 2022-11-04
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Hemarus Plasma in Lauderhill, FL, a plasma center, was cited for two observations during an FDA inspection. The inspection revealed inadequate privacy for donor screenings due to uncovered and non-acoustically protected booths, and a failure to thoroughly investigate donor adverse reactions. Several adverse event reports were found missing crucial follow-up and review information.

## Related Documents

- [483 - 2024-04-30](https://www.keypedia.com/records/483/hemarus-llc/089af159-2304-4568-baa3-6fe2881b7a29)
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## Related Officers

- [Laura E. Garcia](https://www.keypedia.com/people/laura-e-garcia/ad7c9bee-bbff-494f-b9cf-35c3a04316c0)

Company: https://www.keypedia.com/companies/hemarus-llc/7e3cb278-9e15-4ba3-a74b-b27e6993381b

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