# FDA 483 - Tessy Plastics Corporation - February 20, 2026

Source: https://www.keypedia.com/records/483/tessy-plastics-corporation/e33a1ef6-4daa-48d2-b1f6-6f43ca74a118

> FDA 483 for Tessy Plastics Corporation on February 20, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tessy Plastics Corporation
- Inspection Date: 2026-02-20
- Product Type: device
- Office Name: New York District Office
- Summary: Tessy Plastics Corp., a medical device contract manufacturer in Elbridge, NY, received two observations during an FDA inspection. The firm was cited for inadequately documenting its risk management processes, including deficiencies in process failure modes and effects analyses. Additionally, nonconforming product was accepted by concession without sufficient justification, approval, or adherence to regulatory requirements.

## Related Officers

- [Matthew D. Schnittker](https://www.keypedia.com/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.keypedia.com/companies/tessy-plastics-corporation/22d15ce3-6b2b-481f-954e-41b364dae025

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d