# FDA 483 - Drucker Diagnostics - November 21, 2019

Source: https://www.globalkeysolutions.net/records/483/drucker-diagnostics/ecd49e34-3977-4911-873d-f5febdd66443

> FDA 483 for Drucker Diagnostics on November 21, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Drucker Diagnostics
- Inspection Date: 2019-11-21
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: Brucker Diagnostics, a medical device manufacturer in Philipsburg, PA, was cited for a single observation regarding its complaint handling procedures. The firm failed to adequately review and evaluate complaints to determine the necessity of an investigation, specifically for Complaint #6360. Additionally, its procedure improperly exempted devices past warranty from full investigation, indicating a deficiency in the firm's quality system for complaint management.

## Related Officers

- [Katelyn A. Staub-Zamperini](https://www.globalkeysolutions.net/people/katelyn-a-staub-zamperini/bb7f95a4-53c1-473c-856e-517312bdba30)

Company: https://www.globalkeysolutions.net/companies/drucker-diagnostics/408b6c9a-dd6f-4680-abb7-0933a6163552

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8