Teva Czech Industries s.r.o.March 20, 2017

FDA 483 - Teva Czech Industries s.r.o. - March 20, 2017

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Record Details

Teva Czech Industries s.r.o in Opava, Czech Republic, was inspected from March 20-24, 2017, and received one observation. The inspection revealed deficiencies in the firm's procedures for handling drug product complaints, specifically concerning the trending of "lack of effect" complaints and the quality control testing of retention samples. This indicates a moderate severity issue related to quality system controls.

Company: Teva Czech Industries s.r.o.
Inspection Date: March 20, 2017
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Laurimer Kuilan-Torres
Christina A. Miller (Senior Compliance Manager)

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ID · 10b4b052-0f6d-4ba4-8432-8b97f26d8e48