# FDA 483 - INCELL Corporation LLC - September 29, 2023

Source: https://www.globalkeysolutions.net/records/483/incell-corporation-llc/b63b0e6b-4002-4d92-b490-42e1775f7e71

> FDA 483 for INCELL Corporation LLC on September 29, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: INCELL Corporation LLC
- Inspection Date: 2023-09-29
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: INCELL Corporation LLC in San Antonio, TX, was inspected regarding its HCT/P manufacturing. The inspection revealed significant deficiencies in aseptic processing validation, quality control unit procedures, product testing, and stability data for its amniotic fluid-derived injectable products. These issues indicate a lack of robust controls to ensure product sterility, identity, and appropriate expiration dating.

## Related Documents

- [483 - 2015-09-01](https://www.globalkeysolutions.net/records/483/incell-corporation-llc/9aba0cea-8793-41e5-a32b-1192319b2106)
- [WARNING_LETTER - 2023-09-29](https://www.globalkeysolutions.net/records/warning_letter/incell-corporation-llc/dfec7848-d62a-44e4-975d-e98ca9ddfbb1)

## Related Officers

- [Bobbi Miller](https://www.globalkeysolutions.net/people/bobbi-miller/60517ce9-0fee-4099-98ef-c7329af0518a)
- [investigator](https://www.globalkeysolutions.net/people/richard-t-riggie/d07a4551-08b4-44f7-b7d2-02ae3c5dc1e2)

Company: https://www.globalkeysolutions.net/companies/incell-corporation-llc/d4d60997-99ce-45b7-be66-c76ff6e80ec5

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab