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

Source: https://www.keypedia.com/records/483/eosera-inc/4b27806f-0243-4ab2-bea7-648c2df4130f

> 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: Division of Human and Animal Food Operations - West III
- Summary: Eosera, Inc., an OTC drug manufacturer in Fort Worth, TX, received a Form 483 with two observations during an FDA inspection. The firm was cited for failing to adequately follow quality control unit procedures regarding changes to operations and for not establishing written cleaning validation procedures for manufacturing equipment. These issues indicate deficiencies in the firm's quality system and equipment maintenance practices.

## Related Documents

- [483 - 2020-01-17](https://www.keypedia.com/records/483/eosera-inc/c776aca9-7268-427b-8184-60a16a1e4ba7)
- [WARNING_LETTER - 2020-01-17](https://www.keypedia.com/records/warning_letter/eosera-inc/902d53ce-5022-472e-a89f-cfc852ba42df)
- [483 - 2025-04-28](https://www.keypedia.com/records/483/eosera-inc/a5bd0ed3-25e7-4571-82cd-abe754c3ecdf)

## Related Officers

- [investigator](https://www.keypedia.com/people/kevin-t-nguyen/5ae9d562-7e4f-4305-895a-4b39c35acd16)

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

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