# FDA 483 - Teva Womens Health, LLC - March 26, 2025

Source: https://www.keypedia.com/records/483/teva-womens-health-llc/ffc8d066-ec32-4113-b8b0-5c000b96314c

> FDA 483 for Teva Womens Health, LLC on March 26, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Teva Womens Health, LLC
- Inspection Date: 2025-03-26
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Teva Womens Health, LLC in Cincinnati, OH, was inspected and received a Form 483 with four observations. The inspection revealed deficiencies in deviation investigations, laboratory control mechanisms, equipment cleaning and maintenance procedures, and contamination control systems. These issues indicate a lack of adherence to established quality and manufacturing practices.

## Related Documents

- [483 - 2018-01-26](https://www.keypedia.com/records/483/teva-womens-health-llc/6cb28d31-bd1d-49c3-a0e4-024bdce8c666)

## Related Officers

- [Paranthaman Senthamarai Kannan](https://www.keypedia.com/people/paranthaman-senthamarai-kannan/12221263-b29b-4696-9e6e-84e659ae43cd)
- [Young K. Chou](https://www.keypedia.com/people/young-k-chou/3f34cb70-7f30-453d-9099-885e1b168975)

Company: https://www.keypedia.com/companies/teva-womens-health-llc/eea6ef47-7964-4c7b-8094-2fd46b336b60

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22