FDA Inspection
Trinity Sterile, Inc.Trinity Sterile, Inc. – FDA Inspection, Mar 13, 2017
Record Details
This FDA Inspection record concerns Trinity Sterile, Inc., with an inspection on March 13, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 0ccbdadd-6214-4d70-8a6b-e6f0c98a1d28
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1004661
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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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 |
| April 26, 2019 | 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 1087531 - 2019-04-26
- FDA Inspection 818470 - 2013-02-13
- FDA Inspection 678565 - 2010-09-01
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