# FDA 483 - Eosera, Inc. - January 17, 2020

Source: https://www.globalkeysolutions.net/records/483/eosera-inc/c776aca9-7268-427b-8184-60a16a1e4ba7

> FDA 483 for Eosera, Inc. on January 17, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eosera, Inc.
- Inspection Date: 2020-01-17
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Konec, Inc., an OTC manufacturer in Fort Worth, TX, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed significant deficiencies in process validation, quality control procedures for rejecting out-of-specification products and components, unsupported expiration dates, and inadequate microbiological testing of raw materials. These issues indicate a lack of robust quality systems to ensure product quality and safety.

## Related Documents

- [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/a5bd0ed3-25e7-4571-82cd-abe754c3ecdf)
- [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/shanna-n-purdy/7a677cf5-484f-4e9a-91b1-27398411ff32)
- [Investigator](https://www.globalkeysolutions.net/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)

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