Inspections, Compliance, Enforcement, and Criminal Investigations
7-7 - NOTIFICATIONS AND PUBLIC WARNING
- Identification of Recall Documents
All units referencing recall actions should identify them by the RES generated "Record Event Number." After classification, the recall number(s) may be added, but the primary identification will still be the Record Event Number. This will allow all FDA personnel operating in the RES to immediately locate the required recall record.
District recall coordinators will update the status of recall actions in RES when they become aware that a recalls status has changed from "ongoing" to "completed" to "terminated." They will so advise the CRU, which will then update the FDA web page by reposting the recall record.
For certain Class I recalls and Class II recalls, when required by the audit program, the district office will send a weekly progress report to the CRU and OE/DCMO until the recall is completed or until advised otherwise by OE/DCMO.
Monthly or bi-monthly status reports on recall actions within the districts are not required by headquarters, but may be prepared at the discretion of district management for district recall operation monitoring purposes only.
District Notification to the Recalling Firm
The monitoring district, upon receiving the recall number, classification, and recall strategies from the center, will then promptly prepare and send a notification letter to the firm stating the agency's position with respect to the recall. Prior to issuing the recall notification letter, the district may notify the recalling firm by telephone of the recall classification and its posting on FDA’s website.
This letter will provide the recall number(s), the classification of the recall, an agency assessment of the firm's recall strategy, i.e., type of notification, depth of recall, and level of effectiveness checks, as well as any suggested strategy revisions. It will indicate FDA's determination to verify returned product disposition by stating that the district office should be notified prior to the initiation of reconditioning or destruction of recalled products and that such action should be witnessed by an FDA investigator. (An alternative means, such as verification by appropriate state or local officials, may be used.) The letter should also inform the firm that the recall has been posted on the FDA website. The letter should encourage proper corrective action, and request periodic status reports from the recalling firm as described in 21 CFR 7.53(b). The letter should include a statement that failure to conduct an effective recall could result in either seizure of the violative product or other legal sanctions under the FD&C Act or related statutes.
The notification letter should be prepared for the signature of the district director or his/her delegate. It should also include the name and telephone number of the district's recall coordinator to assist the firm in answering any questions related to the recall classification.
A sample Notification Letter is attached as Exhibit 7-7. This exhibit serves only as a model. These letters should be written on a case-by-case basis and tailored to each unique recall situation.
In situations where there is an urgent need for a more prompt notice, i.e., FDA requested recalls, Class I recalls, or pending FDA press release, the district office will visit or telephone the firm, and follow-up with a confirmatory letter as appropriate.
In instances where the recall is terminated at the same time it is classified, the district will prepare a combination notification/termination letter to the firm. This letter will provide the recall number(s), the classification of the recall, and indicate that FDA considers the recall terminated. A sample Notification/Termination letter is attached as Exhibit 7-10.
- Audit Check Reports
Report all recall audit checks on form FDA 3177, Recall Audit Check Report. See Exhibit 7-12A for a copy of the report and Exhibit 7-12 for the audit check report instructions.
OE/DCMO is responsible for maintaining contacts and notifying headquarters organizations about significant recalls. These include the Center Recall Unit, Division of Federal State Relations (DFSR), Office of International Programs, Media Relations Staff in the Office of Public Affairs, and the Division of Compliance Information and Quality Assurance (DCIQA) in the Office of Enforcement. In emergency recall situations, DCMO will keep FDA’s Emergency Operations center apprised of recall status. DCMO advises the USDA, DOD, and other federal government agencies of recalls in which they are involved. DCMO also advises government officials in Canada and Mexico of recalls, in accordance with existing MOU’s and CUMCIG (Canada-United States-Mexico-Compliance Information Group).
Notification of State and Local Officials
District offices should consider appropriate notification to state and/or local officials of recall actions that may be pertinent to them. The districts should also consider requesting necessary assistance from state and local officials either in conducting or auditing recalls.
DFSR informs State and local officials by electronic mail system of selected recalls presenting serious health hazards, where intense publicity is anticipated, and/or where state assistance is requested. DFSR also distributes other publicity prepared by the Office of Public Affairs (HFI-3), to these officials.
Foreign, Military, and Other Federal Government Distribution
The district coordinator should submit a list of foreign, military, and other federal government consignees to OE/DCMO in RES with the Recall Recommendation submission, or, if this information is known at the time, with the 24 hour alert.
OE/DCMO notifies the Office of International Programs (OIP) of all Class I recalls where product was distributed to foreign countries except Canada. OE/DCMO informs International Relations Staff (IRS) of specific foreign consignees. OE/DCMO also responds through IRS to all requests for recall information from American embassies.
OE/DCMO notifies Canadian food, drug, and device regulatory authorities of every recall, in accordance with established communication agreements. They inform Canada of recalls of products shipped to Canada and of recalls of Canadian products in the United States.
OE/DCMO notifies IRS of recalls of imported products to expedite locating all importers of the violative product.
OE/DCMO notifies the USDA, Food Safety and Inspection Service (FSIS) and the Food Nutrition Service (FNS) of recalls of FDA regulated products that have been distributed to any USDA agency that may have involvement with the school lunch program.
Responsibility and Procedures - OC, Office of International Programs, (HFG-1)
For all Class I recalls involving foreign consignees other than Canadian, OIP/IRS summarizes and transmits essential information to the appropriate counterpart agency in the foreign country. It provides a copy of the foreign notification to the CRU and OE/DCMO.
At the request of OE/DCMO, OIP/IRS contacts appropriate counterpart foreign agencies to have them contact foreign manufacturers or distributors in order to determine name(s) and location(s) of United States importers of the firm's product(s) found to be violative and under recall in the United States. It provides foreign agency responses to OE/DCMO.
OIP/IRS coordinates the development of responses to foreign embassy inquiries with the centers and OE/DCMO.
OIP/IRS provides the CRU and OE/DCMO with foreign counterpart agency responses regarding the effectiveness of recall actions, so that the effectiveness of the recall notification to foreign consignees may be properly evaluated.
Responsibilities and Procedures - Division of Compliance Information and Quality Assurance (HFC-240)
OE/DCMO notifies the Division of Compliance Information and Quality Assurance (DCIQA) when medical products under recall (Class I and Class II) have been distributed to any federal agency and advises about impending Class I and other serious recalls of drugs and devices shipped to the Department of Defense (DOD), Department of Veterans Affairs (DVA), or General Service Administration (GSA) facilities.
DCIQA uses established systems and relationships with DOD, DVA, and the GSA to provide information or obtain cooperation relative to drugs, biologics or devices shipped to these agencies and presenting serious health risks.
DCIQA notifies appropriate federal purchasing agencies (DVA, GSA, and DOD) of all Class I recalls and of those Class II recalls of medical products which have been distributed to federal agencies. They receive and coordinate Class I recall audit check data from other government agencies and forward the data to OE/DCMO.
All industry product removal or corrective actions classified by the agency as recalls will be posted on FDA’s Recalls and Safety Alerts web page. All recall alerts and recommendations submitted to the CRUs will, unless determined by the CRU at the outset to be market withdrawals or non-classifiable, be immediately posted by the CRU on FDA’s Recalls web page. These recall postings will then be updated by the CRU as they are classified and/or when significant changes, recall extensions, etc., are provided by the district coordinators or otherwise brought to the attention of the CRU. Additionally, the Office of Public Affairs (OPA) web page manager will update the recall document with Internet addresses for any press statements issued either by FDA, a state agency, and/or the recalling firm.
It is FDA’s policy that press releases issue for Class I recalls unless specific circumstances indicate that a press release would not be beneficial to the public. Publicity may be issued by either the recalling firm or by FDA. Agency policy gives the recalling firm the first opportunity to prepare and issue publicity concerning its recall. The field recall coordinators will work with the recalling firm to prepare a press release. The OPA Media Relations Staff, the CRU and/or OE/DCMO Recall Staff are available to provide assistance. The CRU will also assist the OPA Media Relations Staff, along with the district recall coordinator and OE/DCMO, in the preparation of FDA publicity.
If hazardous products contain defects that require extensive design and/or test time to ensure both the firm and FDA that a certain recall or corrective action program is appropriate, the agency will require prompt, preliminary communication to consumers/users to prevent unnecessary injury.
District recall coordinators will promptly provide (electronically if possible) copies of all recalling firm or state agency issued press releases to the OPA Field Liaison Officer, the FDA Website Management Staff, the CRU and OE/DCMO. The Website Management Staff will update the recall website URLs to link users to the press releases.
When appropriate, the CRU will forward press releases and/or other recall documents for posting on the center’s and/or the MedWatch website.
Additionally, notices or warnings may be issued to health professionals, trade associations, etc., for the purpose of alerting these populations to either serious health hazards or other situations deemed to be in the public interest.
- Responsibilities and Procedures – Associate Commissioner for Public Affairs
- Advises the ACRA on the appropriateness of publicity for all recall actions;
- When a recall’s strategy includes FDA publicity, prepares and issues publicity with the assistance of the appropriate center, district, and OE/DCMO. Obtains ACRA concurrence on all recall publicity;
- Alerts the appropriate home district of the expected release of publicity;
- Through the Media Relations Staff (HFI-21), ensures that recall actions are included in the FDA Enforcement Report until such time as the Internet portion of RES is made available to the public on FDA’s website, and the agency concludes that the Enforcement Report may be discontinued. Specifically, the staff will:
- Complete the recall entry for the FDA Enforcement Report upon receipt of the recall classification and number(s) from the CRU;
- Coordinate the development of the draft and final report with the CRUs and OE/DCMO.
- Distribute the report to ORA headquarters and field offices, the press, other federal government agencies, consumers, and the CRUs.
Note: As soon as the Internet portion of RES is released to the public, recall information provided by the field and centers will be uploaded on a real time basis onto a FDA web page without OPA involvement with one exception. The Website Management Staff will be provided press releases from recalling firms and/or state agencies. The link to the press release will then be provided on the specific recall web page.
- In cooperation with the CRU and OE/DCMO, prepares "Talk Papers" on high interest recalls that do not warrant a press release;
- Evaluates the effectiveness of recall publicity and, if determined to be inadequate, initiates action to ensure effective notice; and,
- Handles or coordinates responses to all media calls regarding recall situations.