# FDA 483 - Kalchem International, Inc. - December 20, 2024

Source: https://www.globalkeysolutions.net/records/483/kalchem-international-inc/cab0584e-f298-45f4-8e40-5e8e892d7a6b

> FDA 483 for Kalchem International, Inc. on December 20, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kalchem International, Inc.
- Inspection Date: 2024-12-20
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Kalchem International in Lindsay, OK, from December 16-20, 2024, revealed a significant issue regarding the storage of active pharmaceutical ingredients (APIs). The firm failed to ensure that equipment used for API storage, specifically a refrigerator, was qualified for its intended use and properly segregated quarantined and approved materials. This indicates a lapse in equipment control and material management practices.

## Related Documents

- [483 - 2020-02-21](https://www.globalkeysolutions.net/records/483/kalchem-international-inc/87c1d1d9-1853-4551-b69c-295d241e391c)
- [WARNING_LETTER - 2020-02-21](https://www.globalkeysolutions.net/records/warning_letter/kalchem-international-inc/f4853f7d-3198-4e91-bc61-238a4930a830)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/demario-l-walls/c69c4c87-f001-45ab-8d7b-b45c60226ff1)

Company: https://www.globalkeysolutions.net/companies/kalchem-international-inc/8e4c7e82-75c6-4bb8-a011-ecb637fa2d70

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