# FDA 483 - Kath Khemicals LLC - April 03, 2025

Source: https://www.globalkeysolutions.net/records/483/kath-khemicals-llc/089f41ac-0308-4205-a1c4-84cf0c6e00f4

> FDA 483 for Kath Khemicals LLC on April 03, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kath Khemicals LLC
- Inspection Date: 2025-04-03
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: An FDA inspection of Kath Kchemicals LLC in Macomb, MI, revealed significant deficiencies in their manufacturing practices for drug products, including McD Foaming Antibacterial Hand Soap. The firm lacked a functional quality control unit, failed to perform essential identity, stability, and microbial testing, and had inadequate production and process controls. Many of these issues, such as the absence of proper testing and incomplete batch records, were repeat observations from previous inspections, indicating a persistent failure to comply with good manufacturing practices.

## Related Documents

- [WARNING_LETTER - 2025-04-03](https://www.globalkeysolutions.net/records/warning_letter/kath-khemicals-llc/5b2f78c0-c705-4898-ac27-fd82b3070486)

## Related Officers

- [Shannon L. Maisano](https://www.globalkeysolutions.net/people/shannon-l-maisano/2cce259d-0fbe-44ef-b43e-7292da739470)
- [Nicholas J. Presto](https://www.globalkeysolutions.net/people/nicholas-j-presto/2ecdd573-6662-4d07-b93c-ddb9c603bcfa)

Company: https://www.globalkeysolutions.net/companies/kath-khemicals-llc/9c1c329b-5bad-4e24-b029-b8ea36f97f40

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03