# FDA 483 - Evologics, LLC - July 27, 2021

Source: https://www.globalkeysolutions.net/records/483/evologics-llc/ad19a201-8536-462b-bc66-2faf4c779e1b

> FDA 483 for Evologics, LLC on July 27, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Evologics, LLC
- Inspection Date: 2021-07-27
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Evologics, LLC, an HCT/Ps distributor in San Antonio, TX, was inspected by the FDA from July 21-27, 2021. The inspection revealed a significant issue with record-keeping practices, specifically concerning the concurrent documentation of returned human tissue products. This indicates a moderate severity issue related to quality control and compliance with regulatory requirements for tissue handling.

## Related Documents

- [483 - 2019-08-27](https://www.globalkeysolutions.net/records/483/evologics-llc/d2df915d-f002-4b95-ae8c-5cd3a58a3150)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/richard-t-riggie/d07a4551-08b4-44f7-b7d2-02ae3c5dc1e2)

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

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