FDA Inspection
Tessy Plastics CorporationTessy Plastics Corporation – FDA Inspection, Feb 20, 2026
Record Details
This FDA Inspection record concerns Tessy Plastics Corporation, with an inspection on February 20, 2026, issued by the New York District Office, covering medical devices & rad health.
- Company
- Tessy Plastics Corporation
- Inspection Date
- February 20, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 0f46ddac-bd47-4946-b012-c3610d995920
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1304490
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
2- ISO 13485:2016 Clause 8.3.2Nonconforming product concessions accepted without meeting requirements
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Tessy Plastics Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 28, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 19, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 31, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 14, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 13, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Tessy Plastics Corporation
- FDA Inspection 1176152 - 2022-07-28
- FDA Inspection 1112307 - 2019-11-19
- FDA Inspection 991783 - 2016-10-31
- FDA Inspection 795807 - 2012-08-14
- FDA Inspection 775458 - 2011-12-13
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