# FDA 483 - PolarityTE, Inc - July 13, 2018

Source: https://www.globalkeysolutions.net/records/483/polarityte-inc/629ff528-fe1f-433b-9bd9-93fb3d28a509

> FDA 483 for PolarityTE, Inc on July 13, 2018. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PolarityTE, Inc
- Inspection Date: 2018-07-13
- Product Type: biologics
- Office Name: Denver District Office
- Summary: PolarityTE, Inc. in Salt Lake City, UT, a biological drug establishment, was inspected by the FDA from July 9-13, 2018. The inspection revealed significant deficiencies in production and process controls, environmental monitoring, facility design, and quality control for their SkinTE product. These issues indicate a lack of adequate procedures and documentation to ensure product identity, strength, quality, and purity, raising concerns about aseptic processing and contamination control.

## Related Documents

- [483 - 2018-07-13](https://www.globalkeysolutions.net/records/483/polarityte-inc/429b96a5-4cad-417d-8c4a-5863831498eb)

## Related Officers

- [Manager, Data Science and Engineering](https://www.globalkeysolutions.net/people/kelly-d-moore/a5778f12-e968-4fc9-8391-b2cb5753232a)
- [Scott T. Ballard](https://www.globalkeysolutions.net/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)
- [Travis S. Bradley](https://www.globalkeysolutions.net/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)

Company: https://www.globalkeysolutions.net/companies/polarityte-inc/5284c15a-e78f-450d-b0a1-db384037f1b0

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