FDA Provides Specifics for the Recall Process
(Thursday, March 24, 2022)
All manufacturers of FDA regulated products are required to be “recall ready” per specific criteria set by the FDA, at all times, failure to do so could lead to FDA compliance actions. The primary target audience for the new FDA guidance on the topic appears to be manufacturers of food, supplements, cosmetics, and many other products regulated by FDA that do not require formal approval to be marketed and are generally dependent on manufacturer-initiated supply-chain controls including recalls. Firms occasionally need to initiate “voluntary recalls” to remove defective products from the supply chain. While evaluation of the established processes for product recall is a criterion for pre-approval GMP inspections for drug, biologics, and prescription medical device manufacturers, the same is not true for other products. Voluntary product recalls must be appropriately orchestrated to protect consumers. The new FDA Guidance Document provides a list of general preparatory activities and recommended procedures for initiating and executing the product recalls when needed. The general preparatory tasks include identifying and training personnel who would lead the recall process, establishing a recall communication plan for both internal and external personnel (including informing FDA and other regulatory agencies of a recall activity, as applicable), identifying reporting requirements based on the type of recall, and maintain detailed product tracing documentation. Upon becoming aware of a product defect that meets the criteria for initiating recall, the firm is required to immediately cease distribution activities, notify affected customers/clients, provide instructions for disposition of the recalled product, and notify public, if applicable. A product recall is a major event which is preceded with investigation of a reported product defect followed by decisions regarding initiating a recall and execution of the recall. FDA expects manufacturers to recall products in a timely manner and in an appropriate fashion. The FDA guidance does not contain any information that would be new to drug, biologics, or medical device manufacturers, but for all other manufacturers and distributors of FDA-regulated products, this guidance is a blueprint to the SOPs and instructions they need to stay compliant with FDA requirements.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC