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483
•Discus Dental LLC•October 17, 2019

FDA 483 - Discus Dental LLC - October 17, 2019

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Record Details

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.

Company
Discus Dental LLC
Inspection Date
October 17, 2019
Product Type
Drugs
Office
Division of Pharmaceutical Quality Operations IV
People
  • Marcus F. Yambot (Senior Consumer Safety Officer )
  • Diane R. Weidley
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ID · 466bdfdf-3c1b-4568-99b9-0fe7c9729c0e

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