# FDA 483 - Tessy Plastics Corp. - April 16, 2026

Source: https://www.keypedia.com/records/483/tessy-plastics-corp/e667370f-7118-4be8-b1c6-c9baffc23ee3

> FDA 483 for Tessy Plastics Corp. on April 16, 2026. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Tessy Plastics Corp.
- Inspection Date: 2026-04-16
- Product Type: device
- Office Name: New York District Office
- Summary: An FDA inspection of Tessy Plastics Corp., a medical device contract manufacturer in Skaneateles, NY, revealed significant deficiencies in their cleanroom operations. The firm failed to adequately document infrastructure maintenance activities and procedures for cleanroom cleaning, leading to visible particulate accumulation on manufacturing equipment. Additionally, the company did not properly monitor and control the work environment, as evidenced by an uninvestigated particle count excursion and a lack of required retesting.

## 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-corp/04cd6415-c6dc-486f-9c93-6c7bd8ebf17c

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