According the recently published FDA Guidance, the purpose of this guidance is to clarify FDA’s recommendations for industry and Agency staff regarding timely initiation of voluntary recalls under 21 CFR part 7, subpart C – Recalls (Including Product Corrections) – Guidance on Policy, Procedures, and Industry Responsibilities. The guidance discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures; to ensure timely identification of, and response to, product problems that might lead to a recall; and to promptly issue recall communications and press releases or other public notices. It also discusses preparations firms in the distribution chain should consider making to ensure timely responses to a recall communication. Additionally, it discusses how FDA assists firms with carrying out their recall responsibilities to protect the public health from distributed products in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other laws administered by FDA. This guidance applies to voluntary recalls2 of products subject to FDA’s jurisdiction, including any food, drug, and device intended for human or animal use, any cosmetic and biological product intended for human use, any tobacco product intended for human use, and any item subject to a quarantine regulation under 21 CFR part 1240. This guidance applies to devices that are electronic products regulated as radiology devices subject to 21 CFR part 892. It does not apply to electronic products subject to 21 CFR parts 1003 and 1004.
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 Part 7, Subpart C
- Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls Guidance for Industry and FDA Staff
- Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff
- Industry Recall Guidance: Product Recalls, Including Removals and Corrections
- Recalls Background and Definitions
- Recall Regulations in 21 CFR Part 7
- Index of Model Press Releases:
- Allergens (Allergy Alert)
- Listeria monocytogenes
- Clostridium botulinum
- Salmonella (all serotypes)
- E. coli 0157:H7
- Medical Device
- Human Drug
- ORA Recall Coordinators
- Index of Generic Model Letter Exhibits in FDA Regulatory Procedures Manual:
- 7-1 – Effectiveness Check Letter
- 7-2 – Effectiveness Check Response Format
- 7-3 – Effectiveness Check Questionnaire
- 7-4 – Recall Letter
- 7-5 – Recall Return Response Form
- 7-6 – Recall Envelope
- Medical Device Model Recall Notification Letter and Response Form
- Medical Device Recall Training Modules
- Assisting Interested Parties in Addressing Marketplace Confusion Over the Identity of Food Products Subject to Recall
Conducting a mock recall is not a formal regulatory requirement of the FDA. The FDA recently released its FDA guidance that stresses the importance of being “recall ready” and outlines steps companies should take to develop recall policies and procedures that includes recall planning, training, and record-keeping across all departments to reduce the time a recalled product stays on the market. This effects medical device, consumer products, food, drug industries and others.
To help create and test recall plans, mock recalls can prepare companies for an actual event. In some cases a recall could involve 100+ individuals, within an organization, trying to coordinate all recall efforts. From QA to sales, legal to PR, purchasing to production, operation to marketing, and many more are involved in a mock recall exercise. With this in mind, it is common for medical device, food, drug, consumer product companies to test their recall plan once or twice a year. Why? Because many individuals, within an effected department change, and the new players need training in the mock recall exercises to test their recall readiness.
Guidance documents represent FDA’s current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.
The FDA offers a list of industry guidelines as it relates to market recalls and withdrawals.
As a part of a recall simulation exercise, mock recalls confirm that your company can trace products throughout the supply chain and determine whether or not your communications plan is efficient. Ultimately, mock recalls are about mitigating risk and measuring your ability to react to an emergency event with as much precision as possible.
A mock recall is an internal exercise to test a company‟s ability to trace and recall product or ingredients using their documented traceability and recall plan. When performing a “mock recall” one needs to create a scenario of a problem with a delivered product.
A lot-trace exercise tests a company’s ability to either forward trace a component from receipt to finished product or backward trace a component of a finished product back to the supplier. This exercise tests a company’s record keeping procedures and systems as well as the internal tracking systems for components and finished goods.
It is recommended your company conduct Recall Simulations at least once a year, with different products and triggers.
- A Recall Simulation tests a company’s entire recall plan, process and execution. The entire team assesses how well it performed and is able to collaboratively identify needed corrective actions. A Simulation is a great refresher for seasoned team members and an excellent training tool for new team members, resulting in an increased awareness of team members’ individual responsibilities and those of their counterparts.
- Companies with multiple plants will benefit by assessing the overall process and core recall team’s roles and responsibilities, as well as the individual processes and extended team’s roles at each plant. This will identify inconsistencies, identify the “best in class” processes and tools, and establish consistency across the multiple plants and/or business units.
The core recall team and top-level decision makers, alternate core team members for training, and other people needed to provide information or tools.
The typical simulation takes one full day.
- A lot-trace exercise tests a company’s ability to either forward trace a component from receipt to finished product or backward trace a component of a finished product back to the supplier. This exercise tests a company’s record keeping procedures and systems as well as the internal tracking systems for components and finished goods.
- A Recall Simulation includes all aspects of a “real” recall situation, and it tests people, processes and systems. One of the most important parts of a Recall Simulation is it puts the team in a situation which allows it to proactively practice its recall process and see how well it follows its plan. RQA will engage the team in complex and emotionally charged activities, such as initial issue investigation with limited information, decision making as a team of unique individuals, lot-trace exercise and root cause analysis, while sifting through an over-abundance of information and records, all under extreme time pressures.
A recall simulation involves a fictitious, but realistic, situation about one of your company’s products currently in the marketplace, created to test the Recall Team’s ability to efficiently and effectively conduct all aspects of a recall. The initial report of an incident is escalated into a true crisis situation as the simulation progresses. Because it involves “real” product, information and records, a realistic situation, and is conducted under time pressure, it is as close to a “real” recall as possible.
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