FDA Inspection 1304490 — Tessy Plastics Corp.
The FDA completed an inspection of Tessy Plastics Corp. on February 20, 2026 in Elbridge, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 20, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Elbridge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23241 | ISO 13485:2016 Clause 8.3.2 | Nonconforming product concessions accepted without meeting requirements |