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

Source: https://www.keypedia.com/records/483/polarityte-inc/429b96a5-4cad-417d-8c4a-5863831498eb

> FDA 483 for PolarityTE, Inc on July 13, 2018. Product: Drugs. 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: Drugs
- Office Name: Denver District Office
- Summary: The FDA Form 483 details observations from an inspection of a facility manufacturing SkinTE product. The firm lacks written procedures for production and process controls to assure drug product identity, strength, quality, and purity. Specifically, quantitative data validating aseptic processing, tissue washing, tissue size, cell counts, and cell type identification for SkinTE is not documented. The Director of Quality described the process as "more of an art than a science," despite at least (b)(4) batches processed since April 2018.

The clean room (b)(4) is not suitably constructed to maintain air quality and positive pressure in ISO 7 areas. On July 10, 2018, SkinTE batch #(b)(4) was processed in an ISO 7 room with 0.0 inches of water pressure. The air handlers for the plenum space are designed for recirculation without fresh air intake, maintaining positive flow by pulling air through construction gaps.

Environmental monitoring in the ISO 7 processing room, housing (b)(4) hoods for SkinTE, is deficient. The Director of Manufacturing Operations stated no growth promotion or positive controls are executed for microbial growth plates. Air and surface samples are not routinely collected, and there is no written procedure for routine monitoring since April 20, 2018.

There is no written stability testing program for SkinTE. The (b)(4) expiry is not supported by documented data, and no data shows

## Related Documents

- [483 - 2018-07-13](https://www.keypedia.com/records/483/polarityte-inc/629ff528-fe1f-433b-9bd9-93fb3d28a509)

## Related Officers

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

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

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