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

Source: https://www.keypedia.com/records/483/teva-czech-industries-sro/10b4b052-0f6d-4ba4-8432-8b97f26d8e48

> FDA 483 for Teva Czech Industries s.r.o. on March 20, 2017. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Teva Czech Industries s.r.o.
- Inspection Date: 2017-03-20
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Senior Compliance Manager](https://www.keypedia.com/people/christina-a-miller/7893b145-2814-4443-a886-29881db45918)
- [Laurimer Kuilan-Torres](https://www.keypedia.com/people/laurimer-kuilan-torres/a7f49e33-9d35-4dfe-8bcc-d369d3834ef4)

Company: https://www.keypedia.com/companies/teva-czech-industries-sro/2a136d23-d81f-49b6-accf-a12f7e28c07b

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd