# FDA 483 - Industrial Woodworking Corp. - March 12, 2025

Source: https://www.globalkeysolutions.net/records/483/industrial-woodworking-corp/3fce51f3-e80a-4ad7-83f5-8c033b34924f

> FDA 483 for Industrial Woodworking Corp. on March 12, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Industrial Woodworking Corp.
- Inspection Date: 2025-03-12
- Product Type: device
- Office Name: Detroit District Office
- Summary: An FDA inspection of Industrial Woodworking Corp. in Zeeland, MI, revealed significant deficiencies across its quality system, particularly in process validation and control for medical device manufacturing. The firm failed to adequately validate key processes, establish proper process controls, and maintain accurate device history records. These issues indicate a systemic lack of adherence to quality system requirements, posing potential risks to product quality and patient safety.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/industrial-woodworking-corp/e84de5a8-d960-4c38-8b1a-82fec6d1488c

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