FDA Inspection
Tessy Plastics CorporationTessy Plastics Corporation – FDA Inspection, Oct 31, 2016
Record Details
This FDA Inspection record concerns Tessy Plastics Corporation, with an inspection on October 31, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4cc8a7d0-c2f5-4f8a-82bf-d912c4a2b596
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 991783
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Tessy Plastics Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 20, 2026 | NAI | New York District Office | Postmarket Assurance: Medical Devices |
| 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 |
| 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 1304490 - 2026-02-20
- FDA Inspection 1176152 - 2022-07-28
- FDA Inspection 1112307 - 2019-11-19
- FDA Inspection 795807 - 2012-08-14
- FDA Inspection 775458 - 2011-12-13
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