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

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.