# FDA 483 - Evologics, LLC - August 27, 2019

Source: https://www.globalkeysolutions.net/records/483/evologics-llc/d2df915d-f002-4b95-ae8c-5cd3a58a3150

> FDA 483 for Evologics, LLC on August 27, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Evologics, LLC
- Inspection Date: 2019-08-27
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: This FDA Form 483 was issued to EvoLogics, LLC in San Antonio, TX, following an inspection of their HCT/P establishment. The inspection revealed significant deficiencies primarily related to adverse event reporting, HCT/P tracking and disposition, and record-keeping practices. These issues indicate a lack of adequate controls over critical quality system elements.

## Related Documents

- [483 - 2021-07-27](https://www.globalkeysolutions.net/records/483/evologics-llc/ad19a201-8536-462b-bc66-2faf4c779e1b)

## Related Officers

- [Traci C. Kelm-CSO](https://www.globalkeysolutions.net/people/traci-c-kelm-cso/3aba916f-6a83-4ed0-a0fa-23584548a3dd)

Company: https://www.globalkeysolutions.net/companies/evologics-llc/cd85e81d-74ac-40c3-a3db-e151014df3cf

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9