# FDA 483 - Eosera, Inc. - April 28, 2025

Source: https://www.globalkeysolutions.net/records/483/eosera-inc/a5bd0ed3-25e7-4571-82cd-abe754c3ecdf

> FDA 483 for Eosera, Inc. on April 28, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eosera, Inc.
- Inspection Date: 2025-04-28
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Eosera, Inc. in Fort Worth, TX, identified two significant issues related to quality control and equipment maintenance for their OTC drug manufacturing operations. The firm failed to adequately follow written procedures for change management, specifically regarding a facility move, and lacked established cleaning validation procedures for equipment used in compounding OTC ear care products.

## Related Documents

- [483 - 2020-01-17](https://www.globalkeysolutions.net/records/483/eosera-inc/c776aca9-7268-427b-8184-60a16a1e4ba7)
- [WARNING_LETTER - 2020-01-17](https://www.globalkeysolutions.net/records/warning_letter/eosera-inc/902d53ce-5022-472e-a89f-cfc852ba42df)
- [483 - 2025-04-28](https://www.globalkeysolutions.net/records/483/eosera-inc/4b27806f-0243-4ab2-bea7-648c2df4130f)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kevin-t-nguyen/5ae9d562-7e4f-4305-895a-4b39c35acd16)
- [Shelby N. Turner](https://www.globalkeysolutions.net/people/shelby-n-turner/77268f33-ae48-4e30-abad-4d79c1077185)

Company: https://www.globalkeysolutions.net/companies/eosera-inc/703b6159-ec09-448d-a592-b17026014ed1

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