CooperSurgical, Inc. – FDA CRL

CooperSurgical, Inc. received a Complete Response Letter (CRL) from the FDA regarding its supplemental New Drug Application (sNDA) for Paragard, an intrauterine copper contraceptive, specifically for a new inserter designed for single-hand placement. The FDA was unable to approve the application in its current form primarily due to an unsatisfactory facility inspection.

During a recent inspection of CooperSurgical's manufacturing facility, the FDA's field investigator could not complete the inspection because the facility was deemed unprepared. A satisfactory inspection is a mandatory prerequisite for the approval of this application. CooperSurgical is required to inform the FDA in writing once the facility is ready for a complete and satisfactory inspection.

While the facility inspection was the core deficiency preventing approval, the FDA also provided several recommendations for future revisions. These included ensuring the prescribing information adheres to regulatory guidelines, correcting formatting errors, and incorporating previous draft labeling. Furthermore, the FDA noted several carton and container labeling issues, such as missing placeholders for lot numbers and expiration dates, inadequate NDC number prominence, and inconsistent terminology. Recommendations were also given for the product's "Placement Guide," suggesting a separate container label, an additional copy of the guide outside sterile packaging, and clarifying critical handling instructions within the guide itself. These labeling and guide recommendations, while not currently approvability issues, should be addressed in future submissions.