# FDA 483 - Wisconsin Pharmacal Company - March 07, 2025

Source: https://www.globalkeysolutions.net/records/483/wisconsin-pharmacal-company/60e269d6-d036-4e3f-a5d9-11de82fe3754

> FDA 483 for Wisconsin Pharmacal Company on March 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wisconsin Pharmacal Company
- Inspection Date: 2025-03-07
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Wisconsin Pharmacal Company, LLC, a non-sterile OTC drug manufacturer in Jackson, WI, was cited for significant quality control and data integrity deficiencies. The inspection revealed instances where drug products failing specifications, including microbial contamination, were released without adequate investigation or recall. Additionally, the firm lacked proper procedures for preventing objectionable microorganisms, maintaining computer system controls, ensuring robust laboratory testing, and documenting equipment use.

## Related Documents

- [WARNING_LETTER - 2025-03-07](https://www.globalkeysolutions.net/records/warning_letter/wisconsin-pharmacal-company/47124ef5-8811-4d3f-8f0c-e6b657e64631)

## Related Officers

- [Melissa M. Steiger](https://www.globalkeysolutions.net/people/melissa-m-steiger/513a7364-15df-474f-8a8a-b5c4ff1cf59f)

Company: https://www.globalkeysolutions.net/companies/wisconsin-pharmacal-company/58554ace-03ed-4c6c-b46a-3212afef4575

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d