# FDA 483 - Discus Dental LLC - October 17, 2019

Source: https://www.keypedia.com/records/483/discus-dental-llc/466bdfdf-3c1b-4568-99b9-0fe7c9729c0e

> FDA 483 for Discus Dental LLC on October 17, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Discus Dental LLC
- Inspection Date: 2019-10-17
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Discus Dental LLC, a drug manufacturer in Ontario, CA, was cited for failing to ensure appropriate laboratory testing for objectionable microorganisms in its drug products. The firm did not determine the suitability of test methods used by its contract laboratory for finished product testing. This indicates a significant lapse in quality control for drug product release.

## Related Officers

- [Diane R. Weidley](https://www.keypedia.com/people/diane-r-weidley/9d67f057-c980-4b7a-abaf-ae534b530662)
- [Senior Consumer Safety Officer ](https://www.keypedia.com/people/marcus-f-yambot/a2266014-ae7e-4d64-aeba-a8cfb873f100)

Company: https://www.keypedia.com/companies/discus-dental-llc/57f068c1-0e7a-4e0f-ade3-bab358a78848

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6