# FDA 483 - Masterbilt Incorporated - June 21, 2024

Source: https://www.keypedia.com/records/483/masterbilt-incorporated/d4db0abe-f0e0-4ced-b4ab-0aa300d7dcd1

> FDA 483 for Masterbilt Incorporated on June 21, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Masterbilt Incorporated
- Inspection Date: 2024-06-21
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Masterbilt Incorporated, a medical device manufacturer in South Bend, IN, was cited for multiple quality system deficiencies during an FDA inspection. The firm failed to adequately validate its cleaning process, establish and follow process control procedures, and monitor process parameters. Significant issues were also found in the control of nonconforming products, the implementation and tracking of corrective and preventive actions, equipment maintenance scheduling, and the maintenance of device history records.

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.keypedia.com/companies/masterbilt-incorporated/893f82d1-817f-4511-8ec1-ef8c7e8e4e6e

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0