# FDA 483 - Park Dental Research Corp - February 14, 2025

Source: https://www.globalkeysolutions.net/records/483/park-dental-research-corp/ad263583-c0d7-4f1e-90c7-1f1e6d8cd98b

> FDA 483 for Park Dental Research Corp on February 14, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Park Dental Research Corp
- Inspection Date: 2025-02-14
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Park Dental Research Corp, a class II dental implant manufacturer in Ardmore, OK, revealed significant deficiencies. The firm failed to adequately document process validation activities, establish procedures for in-process product control including sterilization audits and cleaning, and maintain proper equipment maintenance records. These issues indicate a lack of robust quality system controls.

## Related Officers

- [Cso](https://www.globalkeysolutions.net/people/daniel-j-lahar/d4e329c0-b6a5-42ca-acde-b79413b245ea)

Company: https://www.globalkeysolutions.net/companies/park-dental-research-corp/9695ea09-6af4-4014-8efb-2974d21cd60d

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9