Safety Reporting for Cosmetic Products
Welcome to our Safety Reporting platform, designed to prioritize the safety and well-being of our valued customers. Your feedback is crucial in ensuring the continuous improvement and safety of our cosmetic products. If you've experienced any serious adverse reactions, side effects, or unexpected incidents while using our cosmetic products, your input is invaluable. Reporting serious adverse events helps us investigate and address any potential issues promptly, enhancing the safety profile of our products.
A serious adverse event is an adverse event that:
(A) results in:
- death;
- a life-threatening experience;
- inpatient hospitalization;
- a persistent or significant disability or incapacity;
- a congenital anomaly or birth defect;
- an infection; or
- significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended under conditions of use that are customary or usual; or
(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in (A) above.
Complete the downloadable form below to provide details about the serious adverse event. Please note that there are sections not relevant to Xmondo Hair products including sections D, F and H.
Should you have any immediate concerns or require assistance, please contact our customer support team at support@xmondohair.com.
Thank you for being a part of our commitment to product safety.
Please submit a Safety Report by filling out the FDA Form, and submitting to: safety@xmondohair.com
Privacy Act Statement
Authority: The information collected in this form is provided to comply with the Privacy Act of 1974 (P.L. 93-579) for individuals seeking non-employee student, post-graduate or senior scientist training opportunities from the Food and Drug Administration.
Purpose and Uses: All information collected in this form is required to begin the Traineeship. Completed forms are used by the Staff to meet program selection and on-boarding requirements. Information is also shared with the FDA personnel authorized to administer the program.
Effects of nondisclosure: Disclosure of the information is voluntary; however, collection of this information is necessary to continue with the FDA.
