# FDA 483 - MACLEAN-FOGG - May 22, 2025

Source: https://www.keypedia.com/records/483/maclean-fogg/35873d22-a93a-475f-b5d5-ed98f647192b

> FDA 483 for MACLEAN-FOGG on May 22, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MACLEAN-FOGG
- Inspection Date: 2025-05-22
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: MACLEAN-FOGG in Menomonee Falls, WI, a manufacturer of Class II Sharps Collection Containers, was cited for significant deficiencies during an FDA inspection. The firm failed to validate key manufacturing processes, including injection molding and assembly, and lacked established procedures for identifying valid statistical techniques and sampling plans. Additionally, the company's procedures for receiving and documenting product complaints were found to be inadequate.

## Related Officers

- [Hammam A. Abdallah](https://www.keypedia.com/people/hammam-a-abdallah/fc1ee5c3-b00c-43af-b5a3-1bdc2ad6c5d7)

Company: https://www.keypedia.com/companies/maclean-fogg/1553306f-e270-4bc4-8984-1e67e8c31513

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