Category Archives: DSCSA

25 Sep

Your Product May Be Compliant, but Is Your Supply Chain? What the Gold Star Consent Decree Reminds Us About Managing Risk Across the Supply Chain

FDA-regulated products remain subject to regulatory risk across the supply chain. FDA’s September 23 action against Gold Star Distribution is a reminder that warehousing and distribution are part of the regulated product supply chain. Tips for managing 3PL, warehousing, distribution, supplier, and compliance risks for food, drug, medical devices, and cosmetics across state and federal requirements.

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03 Mar

FDA to Exercise Enforcement Discretion with First Responders Not Meeting DSCSA Product Tracing Requirements

On February 29, 2016, the FDA published a guidance entitled “Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act—Compliance Policy.” The guidance is effective immediately (starting on Tuesday, March 1) and states that the Agency will not take action against first responders failing to obtain product tracing information, as required under

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