FDA Inspection 1312586 — Tessy Plastics Corp.
The FDA completed an inspection of Tessy Plastics Corp. on April 16, 2026 in Skaneateles, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 16, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Skaneateles, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23077 | ISO 13485:2016 Clause 6.3 | Requirements for infrastructure maintenance activities not documented |
| 23080 | ISO 13485:2016 Clause 6.4.1 | Work environment requirements and procedures not documented |