FDA Inspection
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. – FDA Inspection, Feb 15, 2019
Record Details
This FDA Inspection record concerns Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc., with an inspection on February 15, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 15, 2019
- Product Type
- Devices
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ID · ebf62679-f6b9-45f0-8407-17d35ea95c4a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1080894
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 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(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 30, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 7, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 7, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 20, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 22, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
- FDA Inspection 1197996 - 2023-01-30
- FDA Inspection 1150957 - 2021-09-07
- FDA Inspection 889994 - 2014-08-07
- FDA Inspection 791491 - 2012-07-20
- FDA Inspection 597917 - 2009-07-22
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