The Key Elements of Being “Recall-Ready”: What FDA Expects When Time Is Critical

Recalls remain one of the most disruptive and costly challenges across FDA-regulated industries. Whether you are a manufacturer, distributor, or re-packer, the decision to initiate or respond to a recall cannot be delayed without risking regulatory action, financial penalties, and brand damage.

Recent FDA guidance makes clear what the agency expects: swift initiation, clear communications, and documented processes. Being “recall-ready” means your facility has the systems, training, and protocols in place before problems arise — not after. This program explains FDA’s current recommendations on voluntary recalls, direct account notifications, public announcements, and the internal structures every company should prepare in advance.

WHY YOU SHOULD ATTEND

No FDA-regulated sector is immune to recalls — pharmaceuticals, medical devices, biologics, cosmetics, supplements, tobacco, alcohol, and more. Recalls affect both manufacturers and supply chain partners, and failing to act promptly can trigger severe enforcement actions.

Most recalls are voluntary, but companies that delay or mishandle them risk escalated FDA intervention. A recent example: Volvo Group North America paid $130 million for delayed recalls.

This course will give you practical clarity on FDA expectations, what processes your organization must establish, and how to respond correctly when a recall notice arrives. You will leave prepared to protect your company, your customers, and public safety.

LEARNING OBJECTIVES

• Define a recall and other terminology related to a recall.

• Describe when a recall is required.

• What processes need to be implemented to ensure the timely initiation of a recall?

• Identify internal processes to implement to ensure timely recall responses.

• Understand how the FDA will assist your facility with carrying out recall responsibilities.

AREAS COVERED

• Overview of Recall Terminology

• Preparations firms in a distribution chain should consider making to initiate a recall.

• Steps to take to ensure timely identification of and response to product problems that might lead to a Recall (21 CFR Part 7, Subpart C – Recalls)

• Timely Initiation of recall communications

• Preparations a firm should take to respond to a recall in a timely manner.

• When is a recall necessary? (ISO 13485:2016, Clause 8.3 – Control of Nonconforming Product)

• Working with the FDA on recalled products

WHO SHOULD ATTEND

• Quality Assurance Departments

• Quality Control Departments

• Manufacturing Departments

• Regulatory Affairs Departments

• Supervisors, Managers, Directors

• Distributors, CMO’s

• Corporate Attorneys

• Risk Management Professionals

• Customer Service Personnel

• Product safety/pharmacovigilance Personnel

Course Director: MEREDITH CRABTREE

Meredith Crabtree has over 30 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. This includes manufacturing, packaging, labelling and distribution operations. Meredith is the owner of MLKC Consulting is s a Quality Consultant specializing in product label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings.