Regulatory

Organogenesis is committed to the highest standards of ethical conduct and regulatory compliance and is committed to conducting its business affairs and interactions with customers, patients, and health care practitioners in a manner that is compliant with all applicable laws, regulations, and industry guidelines.

The regulatory documents provided below are those that are commonly requested for administrative purposes. These documents are updated on a routine basis. For additional documents or information, please contact the Medical Information Center at 1-888-HEAL-2DAY (888-432-5232), option 6.

Regulatory Documentation Per Manufacturing Site

Canton, Massachusetts

Links to FDA Documents:

Links to Tissue Bank Licenses:

La Jolla, California

Links to FDA Documents:

Links to Tissue Bank Licenses:

Birmingham, Alabama

Links to FDA Documents:

Links to Tissue Bank Licenses: