# FDA 483 - CellSure, L3C - August 02, 2021

Source: https://www.globalkeysolutions.net/records/483/cellsure-l3c/8b419050-b96a-4491-9043-fb9cd663802d

> FDA 483 for CellSure, L3C on August 02, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CellSure, L3C
- Inspection Date: 2021-08-02
- Product Type: biologics
- Office Name: Denver District Office
- Summary: Cellsure, LSC, a stem cell own-label distributor in Salt Lake City, UT, was cited for significant deficiencies in donor screening, recordkeeping, product quarantine, and manufacturing controls during an FDA inspection. The firm failed to adequately screen tissue donors for communicable diseases, maintain proper records for donor eligibility, and establish complete specifications for its contract manufactured placental stem cell products. Additionally, issues were noted with warehousing procedures and the lack of a stability testing program for its distributed stem cell products.

## Related Officers

- [Emily B. Camire](https://www.globalkeysolutions.net/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)
- [Scott T. Ballard](https://www.globalkeysolutions.net/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)

Company: https://www.globalkeysolutions.net/companies/cellsure-l3c/6133765e-3818-4bbf-8871-962046a40e8c

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face