FDA 483 - Iron Mountain Fulfillment Services, Inc - April 18, 2025

During an inspection, the FDA observed that Iron Mountain Fulfillment Services, Inc. in Atlanta, GA, a pet dietary supplement warehouse and distribution facility, failed to establish critical written procedures. The firm lacked procedures for handling product complaints, including adverse event reporting, and for its holding and distribution operations. These deficiencies indicate a significant lack of documented controls over key quality and operational processes.