Welcome to Mock Recall Planning Guide. Here we uncover the latest regarding mock recall planning, exercises, checklists, and resources to help your recall readiness.
Part 6: What is the Role of the Maintenance Team in Mock Recall Planning and Exercises?
The maintenance department plays a significant role in product recall management. Without the maintenance team, an organization can't manage product recalls — and could face lawsuits and expensive government penalties. As we continue our series about the impact of product recalls on different departments, we examine the role [...]
Part 5: What is the Role of a Legal Counsel in Product Recall Readiness and Mock Recall Planning?
Recently, we have explored the roles different business departments play in product recall management, from accounting to customer service. The legal department (or legal counsel), however, perhaps plays the biggest role. A legal team navigates ever-evolving legislation that pertains to product recall management and finding alternative resolutions to [...]
Model Drug Recall Letter Example Template
MODEL DRUG RECALL LETTER EXAMPLE John Doe Laboratories Somewhere, U.S.A. 12345 Control Division Date _______________ (red print) --URGENT: DRUG RECALL -- Nonsterile injectable Re: List 1234, Cyanocobalamin Injection Lot No. 4321 Recent tests showed that the above lot number of this product is not sterile and therefore, [...]
Part 4: What is the IT Department’s Role in Mock Recall Planning Exercises?
You might not associate IT with product recall management, but IT departments have an important role to play in handling recall notices from the federal government and other agencies. Without robust IT procedures and technologies, organizations can't improve recall response times and could experience negative financial and legal [...]
Part 3: What is the Supply and Distribution Department’s Role in Mock Recall Planning Exercises?
Product recalls impact all departments within an organization, but those working in supply and distribution will feel the effects more than most. The truth is, recalls influence every aspect of a supply chain, from sourcing materials and ingredients to distributing products to retailers and customers. So what [...]
Industry Guidance For Recalls
The following is published for the FDA Industry Guidance Covering Information on Recalls of FDA Regulated Products Published March 3, 2022 Information on Recalls of FDA Regulated Products Guidance for Industry and FDA Staff: Questions and Answers Regarding Mandatory Food Recalls Initiation of Voluntary Recalls Under 21 CFR [...]