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•AltaThera Pharmaceuticals LLC•September 19, 2019

FDA 483 - AltaThera Pharmaceuticals LLC - September 19, 2019

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Record Details

Alt-Thera Pharmaceuticals, LLC in Chicago, IL, was inspected from September 17-19, 2019, and received one observation. The firm's quality control unit was cited for lacking responsibility over contract manufactured drug products. This included failures to investigate deviations and perform timely quality audits of their contract manufacturing organization.

Company
AltaThera Pharmaceuticals LLC
Inspection Date
September 19, 2019
Product Type
Drugs
Office
Chicago District Office
People
  • Alan M. Roberts
  • Peng Zhou
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ID · 7482ae77-425a-438e-acb8-aba3676d7a33

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