Issued November 13, 2025
Issued
November 13, 2025
Application
Other • 018680
Review center
Other
Stage
Final Decision
Letter type
Approval Letter
This is a Complete Response letter from the FDA regarding CooperSurgical, Inc.'s supplemental New Drug Application (sNDA) for Paragard (intrauterine copper contraceptive), specifically for a new inserter. The application cannot be approved in its current form due to an incomplete facility inspection and numerous deficiencies identified in prescribing information, carton and container labeling, and the placement guide. The letter outlines detailed recommendations and requirements for resubmission, including a comprehensive safety update.
The application cannot be approved in its present form due to an incomplete facility inspection and numerous deficiencies related to carton/container labeling and the Placement Guide. Key issues include missing required information, inconsistent terminology, unclear instructions for use, and visual clutter. A comprehensive safety update is also required upon resubmission.
During a recent inspection of CooperSurgical, Inc.'s manufacturing facility (FEI, 1316626, NY, USA), the field investigator could not complete the inspection because the facility was not ready. A satisfactory inspection is required before this application may be approved.
Recommended response: Notify the agency in writing when the facility is ready for re-inspection to ensure compliance with manufacturing regulations.
The agency reserves comment on the proposed labeling until the application is otherwise adequate. It is recommended to review labeling resources and use the SRPI checklist to correct any formatting errors to ensure conformance with regulations and guidances.
Recommended response: Review and correct all formatting errors in the Prescribing Information using the SRPI checklist and relevant guidance documents prior to resubmission.
The placeholder for the lot number is missing from the carton labeling.
Recommended response: Add the placeholder for the lot number to the carton labeling in accordance with 21 CFR 201.10(i)(1).
Cited: 21 CFR 201.10(i)(1)
The placeholder for the expiration date is missing from the carton labeling. The format for the expiration date on the Placement Guide is not defined. Recommendations include ensuring no other numbers are in close proximity, identifying the format, and using YYYY-MM-DD or YYYY-MMM-DD format.
Recommended response: Add the expiration date placeholder to carton labeling and define the expiration date format on the Placement Guide, adhering to USP General Chapter <7> and FDA recommendations for clarity and format.
Cited: USP General Chapter <7>
The product identifier is missing. The agency recommends reviewing guidance to determine if the product identifier requirements apply and, if so, adding a placeholder to the carton labeling.
Recommended response: Review the DSCSA guidance for product identifier requirements and add a placeholder to the carton labeling if applicable.
The NDC number lacks prominence due to small font size. It is recommended to increase the font size.
Recommended response: Increase the font size of the NDC number on the carton labeling to improve prominence.
The 'Master Carton' contains additional language not present on the carton. It is recommended to remove this language and clarify the purpose of the master carton.
Recommended response: Remove inconsistent language from the master carton and clearly define its purpose.
Inconsistent terminology is used on the carton to describe the Prescribing Information and Patient Information labeling. Specific phrases need revision to be consistent with the titles of the specific labeling documents.
Recommended response: Revise carton labeling to use consistent and accurate terminology when referring to Prescribing Information and Patient Information documents.
The far-left and far-right panels of the Placement Guide also serve as the container label, creating visual clutter and missing required container label information (e.g., lot number placeholder, linear barcode).
Recommended response: Develop a separate container label with all required information, distinct from the Placement Guide, to reduce clutter and ensure compliance. Revise Placement Guide panels accordingly.
The Placement Guide is proposed to be inside the sterile packaging, preventing users from reviewing it prior to starting the procedure. It is recommended to provide an additional copy outside the sterile packaging.
Recommended response: Provide an additional copy of the Placement Guide inside the carton but outside the sterile packaging to allow pre-procedure review.
Step 1 of the Placement Guide lacks critical information for intended use, including keeping the button in place, not pushing it back and forth multiple times, and keeping the tray horizontal during loading.
Recommended response: Add explicit statements to Step 1 of the Placement Guide to alert users of critical handling points, such as keeping the button in position, avoiding multiple pushes, and maintaining a horizontal tray.
The Placement Guide needs to prominently describe unique use-related tasks. The 'neutral line' is depicted but not labeled, and its location appears inconsistent between steps 1, 2, and 5. Steps 5 and 6 need enhancement to show product deployment at the fundus.
Recommended response: Revise Placement Guide graphics and text to clearly label the 'neutral line', ensure consistency across steps, and enhance depiction of product deployment at the fundus.
The primary issues preventing approval are a failed facility inspection and significant deficiencies in product labeling, particularly regarding required information, clarity of instructions for use, and consistency across different labeling components. A comprehensive safety update is also mandated for resubmission.
Regulatory change impact: Pending sponsor mitigation plan
Approval likelihood after response: 5%
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