# FDA 483 - Hemarus LLC - April 30, 2024

Source: https://www.keypedia.com/records/483/hemarus-llc/089af159-2304-4568-baa3-6fe2881b7a29

> FDA 483 for Hemarus LLC on April 30, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hemarus LLC
- Inspection Date: 2024-04-30
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Hemarus LLC, a Source Plasma Donor Center in Lauderhill, FL, revealed significant deficiencies across multiple areas of operation. The firm failed to adhere to standard operating procedures, maintain adequate records, ensure proper personnel training, and thoroughly investigate adverse events. Several critical issues, including inadequate donor privacy and adverse reaction investigations, were repeat observations from a previous inspection, indicating persistent compliance problems.

## Related Documents

- [483 - 2022-11-04](https://www.keypedia.com/records/483/hemarus-llc/c54fbafa-ffa0-497a-b14b-3817b0e650a7)
- [WARNING_LETTER - 2024-04-30](https://www.keypedia.com/records/warning_letter/hemarus-llc/18eade4c-24cf-44cf-a303-7950dca2a6a4)

## Related Officers

- [Investigator at U.S.FDA](https://www.keypedia.com/people/barbara-t-carmichael/4c451805-e327-450d-b2e5-48a40f6232fe)
- [Ivan E. Reyes](https://www.keypedia.com/people/ivan-e-reyes/69bac3eb-f63c-45f0-8420-85a7e06b884a)
- [Raming V Briones](https://www.keypedia.com/people/raming-v-briones/cf0c5596-2e0f-4d82-ba31-1ed0485c0935)

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