# FDA 483 - Xtreme Tools International, Inc. - January 31, 2025

Source: https://www.keypedia.com/records/483/xtreme-tools-international-inc/ce7c843b-fdb5-4449-8403-5c6c265d42b8

> FDA 483 for Xtreme Tools International, Inc. on January 31, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Xtreme Tools International, Inc.
- Inspection Date: 2025-01-31
- Product Type: drugs
- Office Name: Florida District Office
- Summary: An FDA inspection of Xtreme Tools International, Inc. in Opa Locka, FL, an OTC drug manufacturer, revealed significant deficiencies in their quality control, production, laboratory, and facility systems. The firm failed to establish adequate written procedures, perform necessary testing and validations, and maintain proper controls over materials, labeling, and the manufacturing environment, indicating a broad lack of cGMP compliance.

## Related Documents

- [483 - 2025-01-31](https://www.keypedia.com/records/483/xtreme-tools-international-inc/22258164-6695-4a6d-b613-9a3433224fe2)
- [WARNING_LETTER - 2025-01-31](https://www.keypedia.com/records/warning_letter/xtreme-tools-international-inc/d68b9dd3-8522-4ce6-b305-ad333ace78a4)

## Related Officers

- [Yoriann M. Cabrera Bartolomei](https://www.keypedia.com/people/yoriann-m-cabrera-bartolomei/3f827fbc-dcd1-4698-9bae-e0e93b900d08)
- [Mabany Lizardi](https://www.keypedia.com/people/mabany-lizardi/adcca71c-e996-44e5-9827-d1aa2773e832)
- [Angelica M. Hernandez](https://www.keypedia.com/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)

Company: https://www.keypedia.com/companies/xtreme-tools-international-inc/b909e757-5203-447c-9a75-5f8ef61a5e3e

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9