FDA sent a letter to medical companies expressing concern about the increase in cargo thefts of FDA-regulated drug products, and clarifying its expectations from companies and the agency’s role when thefts occur.
In the letter, Acting Assistant Commissioner for Regulatory Affairs Michael Chappell urged stakeholders to “immediately” review security throughout their supply chains from manufacturing through distribution to the point of sale, stating they should be “one step ahead of thieves” in securing warehouses and transportation. He emphasized that drug manufacturers and others in the pharmaceutical supply chain “have a fundamental responsibility to continuously review their warehouse physical security and security practices and procedures for transporting products to ensure that measures are in place to minimize the risk of warehouse and cargo theft.”
The letter directs firms to contact FDA’s Office of Criminal Investigation when a theft occurs, and provides contact information and a list of questions an FDA district office may ask about the incident. It notes that prompt public notification of a theft is a critical step in protecting public health, and strongly encourages companies to issue press releases as soon as possible after such an incident.
[Editor’s Note: Supply chain concerns will be a key focus in the next issue of IPQ, which will provide an in-depth report on the changing inspection and GMP enforcement landscape in the US, EU, and globally.]