FDA EIR - Teva Womens Health, LLC - January 08, 2020

An FDA abbreviated Good Manufacturing Practices (GMP) and Pre-Approval Inspection (PAI) was conducted at Teva Womens Health Inc. in Cincinnati, OH, from January 6-8, 2020. The inspection assessed the company's readiness for commercial manufacturing of Isotretinoin Capsules (ANDA 076135) and adherence to drug manufacturing regulations, as per CPGM 7356.002 and 7646.832.

The PAI was discontinued due to the company's failure to demonstrate readiness for commercial manufacturing. Main issues identified included an ongoing renovation of the proposed manufacturing area for the drug, uninstalled and unqualified essential equipment, and incomplete cleaning validations for critical equipment such as the encapsulator, bander, and weight sorter, which were used for submission batches.

While the abbreviated GMP inspection concluded without an FDA Form 483, the PAI received a "withhold" recommendation. Teva Womens Health Inc. is required to inform the FDA's Center for Drug Evaluation and Research (CDER) once the API encapsulation suite renovation is complete and all equipment and room qualifications are successfully performed, to demonstrate their preparedness for commercial production.