# FDA 483 - Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. - September 07, 2021

Source: https://www.keypedia.com/records/483/polymer-technology-systems-inc-dba-pts-diagnostics-inc/e61b52ad-13f7-45de-bb13-771d748d864a

> FDA 483 for Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. on September 07, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
- Inspection Date: 2021-09-07
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. in Whitestown, IN, was inspected regarding its manufacturing processes for medical devices. The inspection revealed significant deficiencies in process validation, including inadequate challenging of worst-case conditions and vision system capabilities. Additionally, the firm failed to adequately establish and follow corrective and preventive action procedures for distributed devices, indicating a lack of robust quality system controls.

## Related Documents

- [483 - 2019-02-15](https://www.keypedia.com/records/483/polymer-technology-systems-inc-dba-pts-diagnostics-inc/6fb81136-f4a9-4b04-98f4-5eda07909f52)

## Related Officers

- [Debara R. Reese](https://www.keypedia.com/people/debara-r-reese/277a8fbb-ba4d-4402-be08-16d7977685db)

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/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0