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Robert Fish, Independent Advisor, Quality and Compliance

Every year FDA monitors thousands of recalls of regulated products (over 7,000/year). Though most product recalls are voluntary, the FDA can also order them. Recalls can be very damaging to the reputation of a company and its brands. However, with good planning and management, the damage can be controlled. A good understanding of the regulatory requirements as well as appropriate plans and approaches can provide for good recall management and help to ease the burden.

Regulations and Guidance

First the regulations.

The basic FDA recall regulations are found in 21 CFR Part 7, specifically Subpart C Recalls, 21 CFR 7.40-7.59. Other FDA recall guidance can be found in Chapter 7 of the Regulatory Procedures Manual and Chapter 7 of the Investigations Operations Manual (IOM).

FDA has also issued industry guidance documents Industry Guidance For Recalls, Information on Recalls of FDA Regulated Products and Draft Guidance for Industry, Hazard Analysis and Risk-Based Preventive Controls for Human Foods. All of these FDA documents are linked here and should be used reviewed before constructing a company plan and strategy for recall management.

Voluntary or Mandatory

Though most recalls are voluntary, some are mandatory per FDA. Recalls are mandatory for some foods that could cause serious illnesses or death under provisions of the Food Safety Modernization Act, for some biological products and some medical devices under provisions of 21 CFR Part 810. FDA can request a recall but has no legal authority to demand a recall other than in the mandatory situations as discussed above. However, FDA can still request that a company conduct a recall of a violative product if a recall is not done voluntarily. If the company still refuses to conduct a recall, the FDA does have other regulatory actions available such as seizure or injunction. FDA can also publicize that a product is violative if the company does not voluntarily recall it, so it is generally in the company’s best interest to remove a violative product from the market by recall.

Recall Definition

A recall is a method of removing or correcting products that are in violation of laws or regulations administered by the Food and Drug Administration. As stated above a recall is usually a voluntary action that takes place because manufacturers and distributors must carry out their responsibility to protect the public’s health and well being from a product that presents a risk or gross deception or are otherwise defective.

A recall does not include market withdrawals or stock recovery. A market withdrawal or stock recovery is a company’s removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by FDA or which involves no violation of law or regulations.

FDA’s Health Hazard Evaluation and Classification

A health hazard determination is made by FDA on each recall based on problems or injuries which have already occurred, the age of the population involved, the seriousness of the hazard, the likelihood of reoccurrence of problem as well as the immediate and long-term consequences.

Based on the health hazard evaluation FDA classifies all recalls as Class I, II or III. A Class I recall is on in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. Class II and III recalls are used for products that still violate the law, but the violations are not nearly as serious a threat to human health.

Management Approach

Management must have written plans to include at a minimum:

  1. A detailed SOP that describes how recalls will be managed and how all regulatory requirements will be met.
  2. Procedures for the conduct of mock recalls.
  3. Detailed training for all staff that will be involved in recall activities.

It is important to have top management commitment as recalls can be very stressful for the entire organization. Make sure there is a designated person within the company who if responsible for the management of recalls and who will be on the “recall team”.

Management and others on the team must know the law and regulations surrounding recalls including all of the references listed in this document. Know your responsibilities and what FDA can and cannot do.

Having written recall procedures in place to address all of the above topics is helping, including creating a recall template that includes the necessary details for this plan.

Training is of the utmost important for efficient execution of a recall. All staff who will be involved in recalls should be trained and practice recall procedures and responsibilities. In our experience as consultants, this is where most problems with recall management start. Practice going through a mock recall at least annual so that you can test your systems and identify points that should be strengthened.

Recalling Company Action

Once it has been determined that a recall is necessary, as quickly as possible the manager and recall team should determine the complete distribution of recalled product(s). It is important as part of this strategy to include the depth of recall including wholesale, retail, user levels as well as the effectiveness of each level on a scale from 0-100%. It is important to note that FDA may want to approve the recall strategy.

A recall letter should be developed and be as brief and to the point as possible. The letter should clearly identify the product, explain the problem and the action to be taken.

The recalling company should prepare periodic status reports for FDA. These will usually be required by the Agency every 2-4 weeks and should track progress in notifying customers as well as the number of customer responses. The report will also provide results of effectiveness checks – are customers following instructions or not? Part of your company responsibility will be to determine effectiveness of your recall by contacting consignees to make certain they received your recall communication and followed your instruction. FDA will be doing the same thing.

Once FDA agrees that all reasonable effort has been made to recover the product, a termination report will be prepared that summarizes the amount of product distributed, amount recovered and overall effectiveness of the action.

Company Issues Concerning Recalls

Companies will also need to consider and plan for the after-effects of recalls including damage to the brand and liability concerns.

Damage to brand is one of the most obvious challenges because at a minimum your recall details will be published in the FDA enforcement report where your competitors and the public can see details of your company action. Most companies want to get ahead of this by issuing their own press information to keep the record correct. It is generally to the company’s advantage to issue a press release concerning the recall. In very serious recalls (Usually Class I) FDA may also issue a press release.

Whenever a violative product is on the market there is the potential for lawsuits from consumers. Showing responsible company action by promptly removing violative products from the market can be very helpful in defending any lawsuits that may be filed.

Plan Ahead

A recall situation can be a crisis but with proper procedures, training and knowledge it does not have to be. Regardless of procedures and training you have in place, however, you will likely still want to have a crisis management plan if place for use during recall activities as they can lessen the stress associated. The effectiveness of the recall team, including knowledge and planning, will make the recall go much more smoothly which can help to lessen the brand/company damage.

Potential Problems

Traceability of the distributed product is critical to recall success and must include every unit. You must be able to quickly identify all shipments of the violative product. This is why a mock recall activity is such a good idea – you have an ability to test your systems before they are needed. You must be able to determine complete distribution of the recalled product and do so very quickly. Make sure your recordkeeping supports this. How is quickly defined? Time is subjective, but you cannot take several days or weeks. In today’s world of electronic records execution should be accomplished in a matter of hours.

Through properly worded communications (usually the recall letter) you have an opportunity to help customers understand the complete concern with the product being recalled. You also have a responsibility to ensure those customers follow your recall instructions. That is the basic reason for doing the effectiveness checks. If customers do not follow the disposition instructions, it will be necessary to send a second recall notice. Sometimes, however, the reverse can be true and customers return all product rather than just affected lot(s). Certainly, you do not want to recall any lots or products other than the ones that are in violation. To help avoid this problem make sure your recall letter is clear concerning which product and lot(s) are involved.

Once the product is returned, how will it be disposed of? FDA will often want to witness, or a record of, the actual disposition of the returns. If FDA does not witness, they will at a minimum want documentation of the disposition of the returns to include the amounts and how they were disposed/destroyed.

It is to your advantage to complete recalls as soon as possible, so be certain you monitor recall activities.

Global Multi Agency Involvement

Finally, while this article is only intended to discuss FDA monitored recalls it is important to remember that there may be other agencies involved in any recall actions your company may take. Depending on where you do business this will vary but it could be state agencies or other federal agencies such as Consumer Product Safety Commission or USDA. You must consider this when making your plans.

In summary, recalls can be very stressful and costly to a company. However, with proper knowledge, planning and procedures as discussed here much of that can be controlled.

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