# Westec Plastic Corporation – FDA 483, Aug 24, 2026

Source: https://www.keypedia.com/records/483/westec-plastic-corporation/d12f6e8d-7205-4844-ab9f-77e4cfeb56d4

> FDA 483 for Westec Plastic Corporation on August 24, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Westec Plastic Corporation
- Inspection Date: 2026-08-24
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Westec Plastic Corporation, a contract manufacturer in Livermore, CA, was cited for two significant issues during an FDA inspection. The firm failed to adequately plan and develop processes for product realization, specifically lacking a process risk assessment (pFMEA) and documented methodology for its lifecycle. Additionally, the company did not establish risk-based criteria for evaluating and selecting suppliers, nor did it define clear procedures for monitoring and re-evaluating supplier performance proportionate to risk.

## Related Officers

- [Kevin T. Le](https://www.keypedia.com/people/kevin-t-le/cf8b5086-f585-4dd5-9f5c-f082b8a340f4)

Company: https://www.keypedia.com/companies/westec-plastic-corporation/e191423f-b6f6-4076-9fbf-57b6183ea253

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b