# FDA 483 - Teva Womens Health, LLC - January 26, 2018

Source: https://www.globalkeysolutions.net/records/483/teva-womens-health-llc/6cb28d31-bd1d-49c3-a0e4-024bdce8c666

> FDA 483 for Teva Womens Health, LLC on January 26, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Teva Womens Health, LLC
- Inspection Date: 2018-01-26
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Teva Womens Health Inc. in Cincinnati, OH, a drug manufacturer, revealed significant deficiencies across multiple areas. Observations included a lack of quality control unit responsibility regarding product design and complaint handling, incomplete laboratory records for HPLC data, unsanitary conditions in the pharmacy sampling area, and non-adherence to written procedures for storing packaging and labeling materials. These findings indicate a need for improved quality system oversight and operational compliance.

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- [483 - 2025-03-26](https://www.globalkeysolutions.net/records/483/teva-womens-health-llc/ffc8d066-ec32-4113-b8b0-5c000b96314c)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/kenneth-e-felkley/a765e932-11df-406d-ab45-5bf4ac9ff27b)
- [Investigator ](https://www.globalkeysolutions.net/people/lindsey-schwierjohann/3608e7c0-5bb9-49f0-844d-ddd6f6724fdb)
- [Nicholas L. Paulin](https://www.globalkeysolutions.net/people/nicholas-l-paulin/a8e0649a-614f-499b-8fdc-1217f7d71887)

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

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