# FDA 483 - BioStem Life Sciences - September 15, 2023

Source: https://www.keypedia.com/records/483/biostem-life-sciences/3ea2415f-0b14-4cc8-9d22-d73126841c33

> FDA 483 for BioStem Life Sciences on September 15, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioStem Life Sciences
- Inspection Date: 2023-09-15
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: BioStem Life Sciences in Pompano Beach, FL, a manufacturer of amniotic fluid/membrane and umbilical cord derived products, was cited for significant deficiencies during an FDA inspection. The firm failed to adequately validate manufacturing processes, conduct final product testing for identity and strength prior to release, and establish expiration dates based on appropriate stability data. These issues indicate a lack of adequate controls to assure product quality and purity.

## Related Documents

- [483 - 2023-09-15](https://www.keypedia.com/records/483/biostem-life-sciences/25b94c58-9e47-4588-b7cd-7beeb2b2dcda)

## Related Officers

- [Sergio E. Delgado](https://www.keypedia.com/people/sergio-e-delgado/5edfee62-05aa-44aa-9161-def8f31d3ea2)
- [Ivan E. Reyes](https://www.keypedia.com/people/ivan-e-reyes/69bac3eb-f63c-45f0-8420-85a7e06b884a)
- [Annette Melendez](https://www.keypedia.com/people/annette-melendez/bc1a065d-6408-4c4b-9dcf-c6884e8a75c4)

Company: https://www.keypedia.com/companies/biostem-life-sciences/8bd5184b-7fa5-4821-8bdd-5fae8be6fe62

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