FDA Inspection
Preservation Solutions, Inc.Preservation Solutions, Inc. – FDA Inspection, May 19, 2017
Record Details
This FDA Inspection record concerns Preservation Solutions, Inc., with an inspection on May 19, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f8338d6a-3106-4826-9472-504aee716aae
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1012271
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.130Packaging
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
Showing 10 of 13 citations.
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Other FDA inspections of Preservation Solutions, Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2025 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 14, 2023 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 30, 2021 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 12, 2019 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 10, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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