# FDA 483 - Teva Pharmaceuticals USA, inc - July 18, 2017

Source: https://www.keypedia.com/records/483/teva-pharmaceuticals-usa-inc/fd2aa0a1-7966-4bb2-a8e3-da170e72a79c

> FDA 483 for Teva Pharmaceuticals USA, inc on July 18, 2017. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Teva Pharmaceuticals USA, inc
- Inspection Date: 2017-07-18
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Teva Pharmaceuticals USA, inc, a commercial sponsor in Parsippany, NJ, was cited for failing to ensure proper monitoring of an investigational study. This led to the use of unapproved photocopies of the WOMAC Score Sheet, resulting in distorted data and incorrect subject assessments. The firm's interim monitoring visit reports did not identify these deviations, nor did they document verification of corrective actions.

## Related Officers

- [Regulatory Officer](https://www.keypedia.com/people/peter-r-lenahan/c695dac2-5447-434b-801e-f95e6acf05f1)

Company: https://www.keypedia.com/companies/teva-pharmaceuticals-usa-inc/638c11d6-9c3d-4772-9290-9dd5ca5cc380

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248