Inspections, Compliance, Enforcement, and Criminal Investigations
7-8 - MONITORING AND AUDITING RECALL EFFECTIVENESS
This section includes the following subsections:
It is the recalling firm’s responsibility to determine whether its recall is progressing satisfactorily. The firm has an obligation to conduct effectiveness checks as part of its recall strategy. Effectiveness checks assist in the verification that all known, affected consignees have received notification about a recall and have taken appropriate action.
In some instances, a recalling firm may be unable to check the effectiveness of its recall. This could occur when a recall extends to the consumer-user level, the confidential business records of a firm's customers are not accessible, wholesalers, distributors, or retailers do not cooperate, or, because the urgency of the situation requires an all-out effort. In such cases, FDA will directly assist in this activity and, where necessary, seek assistance from cooperating state and local agencies.
Furthermore, the FDA recognizes that effectiveness checks also serve an audit function, and the agency reaffirms its policy of closely monitoring recalls and assessing the adequacy of a firm's recall efforts. Therefore, as part of its audit responsibilities, FDA will selectively conduct audit checks separately from the effectiveness checks of the recalling firm.
FDA Recall Audit Program Development
The CRU reviews the district recommendation and finalizes the FDA audit program for the recall.
In Class I or other significant recall situations, the CRU should regularly review and update the audit program to ensure its adequacy and to reflect changes in the health hazard evaluation, classification, effectiveness of firm's recall, etc.
Factors in Audit Program Development include:
- Special procedures for monitoring the recall at the firm
- Level and type of audit checks to be conducted, including ensuring that consignees who received recalled product(s) that were purchased for use in a domestic nutrition assistance program (e.g., National School Lunch Program), are included in audit checks.
- Special reporting requirements
OE/DCMO concurs in the use of personnel resources for audit checks for ORA.
- District Responsibilities
In summary, the districts:
- Issue audit check assignments (monitoring district)
- Complete assigned audit checks (monitoring and other districts)
- Notify the CRU and OE/DCMO of progress on recalls and ineffective recalls
The monitoring district director has the overall responsibility for ensuring that the FDA audit program is implemented. The recall coordinator and appropriate supervisory personnel are responsible for the day-to-day management of a recall. They will ensure that the firm's status reports are received and reviewed in a timely manner and that the disposition of recalled products is monitored or verified. They will ensure adequate progress and timely completion of the recall by telephone or establishment visit, as appropriate.
If the monitoring district office encounters unreasonable delays by the recalling firm in conducting the recall, an administrative or legal action should be recommended to the appropriate center compliance branch. The CRU and OE/DCMO should be kept informed of such recommendations.
- Audit Check Issuance
Normally within 10 days of issuance of the firm’s recall communication, the monitoring district will issue audit check assignments at the level in the FDA audit program. Exceptions to the ten day time frame would be made for Class I situations when the recall is to the consumer/user level and it is critical that the agency be certain that the products are off the market or that consumer/users have been notified of the recall action. Audit checks are often issued within 24-48 hours after the district learns of a precedent class I food recall. Exceptions to the 10 day time frame are also to be expected in certain radiation emitting devices and electronic product recalls. In these cases, follow CDRH recommended strategy. When the district considers the 10-day requirement inappropriate, they should recommend to the CRU a new date for issuing the audit checks. The monitoring district must provide specific instructions as appropriate when issuing an assignment to another district office. The assignment should be flagged "Request for Audit Check--Class I or II, Audit Check--Level A, B, C, or D". (See Exhibit 7-11 for format). The district should forward a copy of Class I audit check assignments to the CRU and to OE/DCMO.
Audit Check Completion
The district receiving audit checks assignments should consider them high priority and should accomplish them as soon as possible. Submit copies of audit check reports to the monitoring district. If possible, complete assignments within 10 working days from receipt of the assignment. For Class I recalls, provide audit check reports to the monitoring district at least once a week or more often if so directed.
Visits, rather than telephone calls, are preferable for Class I recall audit checks. Visits are also preferred for Class II audit checks. However, resource restraints may make it necessary to conduct the audit checks by telephone. Ineffective telephone audit checks may need to be followed by a visit to ensure effectiveness of the recall action. Exceptions to Class I and II audit checks will be made only when circumstances indicate that such checks will be of no significant value in FDA’s audit of the recall. Audit checks are not normally performed for Class III recalls. However, the responsible district and CRU must consider the need for such checks in each recall situation.
The issuing district will evaluate audit check reports when received to ensure that they are adequate and then retain them. The district shall document its evaluation of the audit check reports. If, during its evaluation of the audit check reports, the district discovers any issues with the recall or audit checks, including any problems affecting consignees that received recalled product(s) that were purchased for use in a domestic nutrition assistance program (e.g., National School Lunch Program), the district must ensure that appropriate and timely follow-up action is taken. If insufficient information has been collected, the issuing district recall coordinator will advise the endorsing supervisory investigator.
It is the responsibility of the receiving district to notify the issuing district of circumstances which will adversely delay the completion of the assignment. Copies of any such communication should automatically be forwarded to the CRU and to OE/DCMO (HFC-210).
Conducting Audit Checks – Direct and Sub-Accounts
The extent of follow-up and information obtained from consignees of recalled products depends on several factors, including the depth of the recall and the type of recall action requested such as return, field correction, or destruction.
Prior to conducting audit checks for complicated or significant recalls, the district may either prepare information handout sheets or copy the recalling firm's recall communication so that copies may be left with consignees.
- No Sub-Recall Indicated.
When sub-recall is not indicated by the consignee, determine how and when the consignee was notified of the recall and whether the consignee followed the recall instructions. If the consignee failed to follow instructions and recalled product is being held for sale or use, the investigator should request immediate compliance with the instructions. If the consignee has not received the recall notification, give the consignee a copy of the recall information to perform the requested recall action.
- Sub-Recall Indicated.
Where sub-recall is indicated by the consignee, determine how and when they received the notification. If the consignee conducted a sub-recall, determine and report in detail the quantity of product involved, the timeliness of the action, and other data pertinent to the sub-recall. If the consignee has not received notification of the recall, provide the consignee with all pertinent recall data. If the consignee has elected not to conduct the sub-recall action, request that recall instructions immediately be followed, including notification of sub-accounts. Provide any assistance or guidance needed by the consignee to get a sub-recall underway.
- Sub-Recall Refusals.
If the direct or sub-account refuses to initiate recall promptly, the district performing the audit check will advise the monitoring district, OE/DCMO, and appropriate CRU of the situation, and indicate what additional steps the district is taking to achieve a satisfactory sub-recall. Options for consideration include meetings between district management and top management of firms, notification of consignees directly, reporting to State and local officials, recommendation for FDA requested recall, and initiation of administrative proceedings or enforcement actions.
The district in which the direct or sub-account is located is responsible for convincing the consignee to conduct an effective sub-recall or for recommending administrative or legal action, if indicated, to achieve compliance. The monitoring district, the CRU, and OE/DCMO should be kept advised of such recommendation.
Injury/illness reports or other product related complaints should be reported promptly (separately from the audit check report) to the monitoring district and OE/DCMO. The monitoring district should inquire whether or not the adverse event (s) has/have been reported to FDA through programs such as MedWatch.
- No Sub-Recall Indicated.
- Ineffective Recall
If at any time during FDA audit of the recall it is apparent that the recalling firm's recall effort is ineffective, the monitoring district should discuss the situation with the firm. Such additional contact can be made by visit, telephone, letter, facsimile, etc., depending upon the circumstance. Determine what action the firm intends to take to improve its recall efforts such as issuance of additional recall communications, etc. A model letter regarding ineffective recalls is attached as Exhibit 7-8. This type of letter should be developed by the district on a case-by-case basis working closely with the CRU.
If, after this notification, the firm is unwilling to extend or modify its recall, the monitoring district will notify the CRU and OE/DCMO of the situation and recommend appropriate action. Actions to be considered include actions such as FDA-requested recall, initial or further public warning, multiple seizures, and injunction.
A state recall audit (state audit) is an audit of the effectiveness of a recall, which is conducted by a state at FDA’s request. State audits may be used in highly complex recall situations or during urgent public health events, or where it is otherwise in the best interest of public health for FDA to call upon its regulatory counterparts at the federal, state, or local levels for assistance. State audits enhance FDA’s capacity to determine the effectiveness of a recall, and assure that FDA’s and state(s)’ efforts are timely, efficient, and documented so that a timely evaluation can be made and additional follow-up activities can be considered when necessary.
- When State Audits are Considered
FDA may consider state audits in any of the following situations:
- The volume of audits approved by center(s) demonstrates the need for state help to accomplish audit check activities in a timely manner. (“Timely” is based on the health risk of the product subject to the recall.)
- FDA is receiving numerous complaints about recalled product still on retail shelves after a firm has issued a recall notification or public warning.
- FDA determines that the recall is ineffective based on audit check results.
- The recalling district determines that an ineffective recall letter may be necessary.
- Planning and Initiation of a State Audit
The District Recall Coordinator for the recalling firm will make the initial recommendation to ORA/OE Recalls (OE Recalls) and the Center Recall Unit (CRU) for state audit assistance. When the need for state audits is identified, OE Recalls will convene and lead a recall operational planning group that includes representatives from OE Recalls, the recalling district, CRU, OPA, DFSR and DFI.
The recall operational planning group will determine the state audit procedure and strategy (see Strategy for State Audits below). This group may have to work within an Incident Command System structure depending on the situation surrounding the recall.
The District Recall Coordinator for the recalling firm should coordinate the recall strategy by issuing a state audit assignment to the participating state(s) within their own district. Issuance of assignments may also involve other District Recall Coordinators, DFSR and/or OE Recalls when multi-district assistance is needed.
When multi-district assistance is required, DFSR will request state assistance according to RPM 7-7-2 (“Notification of Other Governments and Agencies,” “1. Notification of State and Local Officials”).
- Strategy for State Audits
The state audit strategy should include, but is not limited to, determining:
- What consignees have done to discontinue the use and/or distribution of all intact containers of recalled product and the segregation of these products from those products not subject to the recall.
- The methods distributors use for handling and/or disposing of undistributed recalled products in their warehouse.
- Whether distributors have communicated recall instructions to their consignees, and, if so, by what mechanism (e.g., phone, letter).
- How users may identify (or have identified) recalled products; especially when the products do not have a lot code printed on the individual unit.
A state audit can be conducted by a personal visit, telephone call, or other timely means of communication.
Reporting Audit Results
The recall operational planning group will determine who will receive and evaluate the state audit forms. Original FDA audit checks assigned for the recall should continue to be performed and completed per the original recall audit plan. Separate reports should be prepared to document FDA’s audit results and each individual state’s audit results, for use in preparing an overall, comprehensive report.
- Reports by States
States will be encouraged to use FDA audit check forms (Form FDA-3177), however, this is a voluntary system. If state chose not to document their audit check results on FDA Form-3177, FDA will request specific information from the states so that FDA can determine the effectiveness of the firm’s recall. States will be asked to return audit forms to their local, assigning district office, or provide sufficient information to determine recall effectiveness if they did not use the audit check form.
- Reports by Districts
All district offices will return state audit check forms or equivalent information to the recalling district office’s recall coordinator.
The recalling district should send periodic progress reports, weekly if possible, to the CRU and OE Recalls.
State activities performed in FDA districts other than the recalling firm’s district shall be coordinated by the assisting FDA districts’ recall coordinators to minimize duplication of activities by the states and FDA.
- Follow-up to State Audits – Recall Expansion, Ineffective Recall Letter, etc.
- Recall Expansion
If a recalling firm expands its recall, the recalling district will coordinate new audit assignments with OE Recalls and CRU concurrence.
- Additional state audits
Additional state audits may be considered during the course of the recall.
- Issuance of Ineffective Recall Letter
If state audits reveal and ineffective recall, the recalling district should consider issuance of an ineffective recall letter as per RPM Chapter 7 with the concurrence of the CRU and OE Recalls.
- Public Information
The recall operational planning group will update and relay public information to all relevant offices, as necessary.
- Recall Expansion
- Revisions to this Procedure
Each recall presents its own set of circumstances, many of which change on a constant basis, therefore modifications to these recommended procedures based on the nature of any specific recall may be considered by the recall operations planning group handling the current recall, where necessary. These modifications should be documented by OE Recalls as approved and should then be communicated to the recalling district office as accepted.
- Relationship of this Procedure to CFR Part 7
These procedures are intended to supplement, not replace, those cited in 21 CFR Part 7.