FDA Inspection
Trinity Sterile, Inc.Trinity Sterile, Inc. – FDA Inspection, Apr 26, 2019
Record Details
This FDA Inspection record concerns Trinity Sterile, Inc., with an inspection on April 26, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 87443545-1294-488a-bec4-b7e3b9f73135
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087531
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Trinity Sterile, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 13, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 13, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 1, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Trinity Sterile, Inc.
- FDA Inspection 1239929 - 2024-05-23
- FDA Inspection 1004661 - 2017-03-13
- FDA Inspection 818470 - 2013-02-13
- FDA Inspection 678565 - 2010-09-01
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