# Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. – FDA Inspection, Feb 15, 2019

Source: https://www.keypedia.com/records/fda_inspections/polymer-technology-systems-inc-dba-pts-diagnostics-inc/ebf62679-f6b9-45f0-8407-17d35ea95c4a
Source feed: FDA_Inspections

> FDA inspection 1080894 of Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc., February 15, 2019. Classification: Official Action Indicated (OAI). 7 citations under 21 CFR parts 803, 806 and 820. Form 483 issued. 5 other FDA inspections on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1080894
- Company Name: Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
- Inspection Date: 2019-02-15
- Classification: Official Action Indicated (OAI)
- Classification Code: OAI
- Project Area: Postmarket Assurance: Devices
- Product Type: Devices
- Center: Medical Devices & Rad Health
- Office Name: Center for Devices and Radiological Health
- Citation Count: 7

## Related Documents

- FDA Inspection 1197996 - 2023-01-30
- [FDA Inspection 1150957 - 2021-09-07](https://www.keypedia.com/records/fda_inspections/polymer-technology-systems-inc-dba-pts-diagnostics-inc/8c74339e-0a33-4de9-9ad1-dd4a906598b3)
- FDA Inspection 889994 - 2014-08-07
- [FDA Inspection 791491 - 2012-07-20](https://www.keypedia.com/records/fda_inspections/polymer-technology-systems-inc-dba-pts-diagnostics-inc/e3d2d63c-102c-4658-afc1-688ea9e1d931)
- FDA Inspection 597917 - 2009-07-22

## Related Officers

- [Issuing Officer](https://www.keypedia.com/people/debara-r-reese/277a8fbb-ba4d-4402-be08-16d7977685db)
- [FDA Associated Person](https://www.keypedia.com/people/ian-a-pilcher/d82e7599-0d0b-4373-902b-ee5868e8bd23)

Company: https://www.keypedia.com/companies/polymer-technology-systems-inc-dba-pts-diagnostics-inc/94c44fe7-3801-4f54-a8a1-6c19b71f3da9

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7