# FDA 483 - Creative Foam Corporation - Bremen - November 24, 2025

Source: https://www.globalkeysolutions.net/records/483/creative-foam-corporation-bremen/924e87ba-5588-4f69-a443-e88bc96d3487

> FDA 483 for Creative Foam Corporation - Bremen on November 24, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Creative Foam Corporation - Bremen
- Inspection Date: 2025-11-24
- Product Type: device
- Office Name: Detroit District Office
- Summary: An FDA inspection of Creative Foam Corporation - Bremen in Bremen, IN, revealed significant deficiencies across its quality system. The firm was cited for inadequate procedures related to corrective and preventive actions, process validation, complaint handling, and control of nonconforming products. Additionally, issues were noted with sampling plans, equipment calibration, and maintenance schedules, indicating a need for comprehensive quality system improvements.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/creative-foam-corporation-bremen/723e857a-96d8-46f3-95bc-c65d78033e77

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