# FDA 483 - Prototype & Plastic Mold Company, Inc. - January 10, 2025

Source: https://www.globalkeysolutions.net/records/483/prototype-plastic-mold-company-inc/16230e10-980b-49fb-b1b0-1360707559f8

> FDA 483 for Prototype & Plastic Mold Company, Inc. on January 10, 2025. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Prototype & Plastic Mold Company, Inc.
- Inspection Date: 2025-01-10
- Product Type: other
- Office Name: New England District Office
- Summary: An FDA inspection of Polymer Corporation, a contract manufacturer in Middletown, CT, revealed a significant deficiency in their quality management system. The firm failed to adequately control nonconforming product, specifically by not being able to locate documentation for two external nonconformances related to a Class II medical device. This indicates a breakdown in their established procedures for managing product quality.

## Related Officers

- [Katarzyna Plona](https://www.globalkeysolutions.net/people/katarzyna-plona/ea20d6c6-5d2d-41a0-a755-0647fb9f3250)

Company: https://www.globalkeysolutions.net/companies/prototype-plastic-mold-company-inc/f2befa54-4023-4157-92c2-74a2e4ae5413

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144