# FDA 483 - Teva Pharmaceutical Industries Ltd. - May 23, 2023

Source: https://www.keypedia.com/records/483/teva-pharmaceutical-industries-ltd/4270c853-e324-45e0-baca-4a3fb29ee8f8

> FDA 483 for Teva Pharmaceutical Industries Ltd. on May 23, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Teva Pharmaceutical Industries Ltd.
- Inspection Date: 2023-05-23
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Between May 14 and May 23, 2023, the U.S. Food and Drug Administration (FDA) conducted an inspection of the Teva Pharmaceutical Industries Ltd. facility in Kfar Saba, Israel. This assessment, performed under the authority of the Federal Food, Drug, and Cosmetic Act, identified several significant safety and quality control violations in the manufacturing of sterile and non-sterile human drugs. Primary concerns included inadequate equipment maintenance and cleaning, where investigators discovered unknown residues and broken glass fragments on machinery already certified as clean. The FDA also noted serious deficiencies in sterile processing, such as operators failing to follow proper gowning and sanitization protocols during drug filling. Most critically, the firm failed to thoroughly investigate or resolve recurring microbial contamination, specifically the presence of Bacillus cereus in several production batches. Previous corrective attempts by the company were found to be ineffective. This document serves as a report of objectionable conditions under Section 704(b) of the Act, signifying that products may have been held under unsanitary conditions. While these observations do not constitute a final agency determination, Teva is required to respond by submitting a formal plan for corrective actions or providing justification for any objections to the findings to ensure compliance with federal safety standards.

## Related Documents

- [483 - 2023-05-23](https://www.keypedia.com/records/483/teva-pharmaceutical-industries-ltd/04fce435-0d1a-40f9-9632-eff07c2e11d2)

## Related Officers

- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.keypedia.com/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)
- [issuing_officer](https://www.keypedia.com/people/michael-araneta/c94c95f4-2cda-43f5-a02a-2b5d82fe2c7d)

Company: https://www.keypedia.com/companies/teva-pharmaceutical-industries-ltd/0efdd88c-78c1-478c-aa05-d43a1b90886f

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8