# FDA 483 - Global Plastics Inc. - February 28, 2025

Source: https://www.globalkeysolutions.net/records/483/global-plastics-inc/03db0617-5d1c-42b0-bad4-2a9658d24f4c

> FDA 483 for Global Plastics Inc. on February 28, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Global Plastics Inc.
- Inspection Date: 2025-02-28
- Product Type: device
- Office Name: Detroit District Office
- Summary: Global Plastics Inc., a contract manufacturer in Indianapolis, IN, received a Form FDA 483 with three observations. The firm failed to correctly translate device designs into production specifications, lacked established procedures for in-process product control, and did not properly maintain device history records. These issues indicate significant deficiencies in the firm's quality system.

## Related Officers

- [Melina L. Rodriguez-Upton](https://www.globalkeysolutions.net/people/melina-l-rodriguez-upton/0b540980-5708-4251-8ea6-6254375506f1)

Company: https://www.globalkeysolutions.net/companies/global-plastics-inc/111b6a21-a3d2-4862-a8c0-16022aeeba6a

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