# FDA 483 - Molder Rubber and Plastic Corporation (MRPC) - December 16, 2024

Source: https://www.globalkeysolutions.net/records/483/molder-rubber-and-plastic-corporation-mrpc/291b76bc-70bd-4c05-a612-39ac3bc7d4a5

> FDA 483 for Molder Rubber and Plastic Corporation (MRPC) on December 16, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Molder Rubber and Plastic Corporation (MRPC)
- Inspection Date: 2024-12-16
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Molder Rubber and Plastic Corporation (MRPC) in Butler, WI, received a Form FDA-483 citing significant deficiencies across its quality system. Observations included inadequate process validation, insufficient vendor qualification procedures, and failures in corrective and preventive action processes. Additionally, the firm lacked adequate controls for nonconforming products, specifically regarding out-of-calibration equipment and the assessment of expired materials.

## Related Officers

- [Chad E. Schmear](https://www.globalkeysolutions.net/people/chad-e-schmear/275a4c57-d288-46f9-8257-64fcd96159ce)

Company: https://www.globalkeysolutions.net/companies/molder-rubber-and-plastic-corporation-mrpc/84dd43e3-ff42-4909-9613-8b6dc150411a

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