# FDA 483 - Falls Tech Inc. - June 29, 2021

Source: https://www.keypedia.com/records/483/falls-tech-inc/7f06ba66-daa7-48da-90c3-fbe07276e011

> FDA 483 for Falls Tech Inc. on June 29, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Falls Tech Inc.
- Inspection Date: 2021-06-29
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Falls Tech Inc. in Wichita Falls, TX, was inspected regarding its human tissue operations. The inspection revealed a repeat observation concerning the failure to inspect incoming human cells, tissues, and cellular and tissue-based products (HCT/Ps) for damage and contamination. This deficiency, first noted in 2018, raises concerns about preventing communicable disease transmission.

## Related Officers

- [Elmina E Akwo](https://www.keypedia.com/people/elmina-e-akwo/ecd9066d-1647-4765-ad86-dbe5280241c5)

Company: https://www.keypedia.com/companies/falls-tech-inc/45fc51af-a755-4a7d-8468-168d8f05109b

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