# FDA 483 - Teva Pharmaceutical Industries, Ltd. - May 24, 2023

Source: https://www.keypedia.com/records/483/teva-pharmaceutical-industries-ltd/1885616a-cc25-43ec-bc55-d76cb3d073b3

> FDA 483 for Teva Pharmaceutical Industries, Ltd. on May 24, 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: 2023-05-24
- Product Type: drugs
- Office Name: Human Foods Program
- Summary: Teva Pharmaceutical Industries, Ltd. in Boone, NC, was cited for significant deficiencies in its manufacturing processes for human drugs, including sterile and non-sterile products. The inspection revealed widespread issues with equipment cleaning and maintenance, inadequate procedures for pre-use cleanliness inspection, failure to investigate batch discrepancies, and critical lapses in preventing microbiological contamination in aseptic areas. These findings indicate a high severity of non-compliance with cGMP regulations.

## Related Officers

- [Dean R Michalek](https://www.keypedia.com/people/dean-r-michalek/b758500d-6461-48c0-804f-660344aa3edb)

Company: https://www.keypedia.com/companies/teva-pharmaceutical-industries-ltd/92e8cb0e-42e9-4546-9dd8-10a3b21f94c0

Office: https://www.keypedia.com/offices/human-foods-program/8bff4a0b-7bed-449c-b67b-56a83c96a324