Product Withdrawal Recall Procedures Manual - Illinois

Product Withdrawal & Recall Procedures Manual

Product Withdrawal & Recall Procedures 1441 Brewster Creek Blvd │Bartlett, IL 60103 630-665-9665 phone │630-665-3391 fax

1 Revised: August 23, 2010 CONFIDENTIAL COMMERCIAL INFORMATION

Table of Contents Section #1 Recall & Emergency Product Safety ............................................................................................... 2 Product Recall Procedure ........................................................................................................... 2 FDA - Reportable Food Registry Policy ...................................................................................... 2 Recall Committee ........................................................................................................................ 4 Product Identification Format ...................................................................................................... 4 Product Recall Letter ................................................................................................................... 5 Mock Recalls ............................................................................................................................... 6 Emergency Product Safety .............................................................................................................. 6 Food Safety Hazard Potential & Remedy ................................................................................... 6 GET FRESH PRODUCE Corporate Crisis Management Team ................................................. 6 Local Regulatory Agencies .............................................................................................................. 7 Section #2 Product Withdrawal and Recall Program ........................................................................................ 8 Section #3 Recall Model Forms ....................................................................................................................... 12 Section #4 Mock Recalls Done ........................................................................................................................ 12 Section #5 Actual Recalls Done ...................................................................................................................... 13 Section #6 Customer Complaints .................................................................................................................... 15 Sample Report .......................................................................................................................... 16

Section #7-Current Customer Listing Section #8-Current Product Listing Section #9-FDA Statements



Recall & Emergency Product Safety Product Recall Procedure In the event of a product recall, Get Fresh Produce employees will implement the following procedure: 1. A commodity report is run to identify all customers receiving the recalled product. 2. All customers receiving the recalled product are called and told to mark the product, “DO NOT USE – RECALLED” and set it aside for pick up. 3. A Product Recall Letter is emailed of faxed to all customers receiving the recalled product. Notification is also sent to corporate QA contacts designated by the customer. 4. Drivers are instructed to pickup and return all cases of recalled product to the designated return area in the warehouse. 5. All remaining product in the lot received is destroyed or returned to the supplier as indicated by the Vendor. 6. The supplier is notified of the number of cases returned from customers and on hand. 7. Appropriate credits are issued to the customer and taken from the supplier.

FDA – Reportable Food Registry Policy The Reportable Food Registry (RFR or the Registry) is an electronic portal for the Food Industry to report when there is reasonable probability that an article of food will cause serious adverse health consequences. The Registry helps the FDA better protect public health by tracking patterns and targeting inspections. The Food and Drug Administration Amendments Act of 2007 (Pub. L.110-085), section 1005 directs the FDA to establish a Reportable Food Registry for Industry. The RFR applies to all FDA-regulated categories of food and feed, except dietary supplements and infant formula. Being that Get Fresh Produce, Inc. is a registered food facility through the FDA, under section 415(a) of the FD&C Act (21 U.S.C. 350d), we acknowledge the requirement to issue a report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. In the event of a Product Recall affecting product distributed by Get Fresh Produce, Inc., the following will take place if deemed necessary: • •

Must report as soon as practicable, but in no case later than 24 hours after a responsible party determines that an article of food is a reportable food Must submit certain data elements in the initial report



• • • • •

Must investigate the cause of the adulteration if the reportable food originated with the responsible party. May be required to provide notification to immediate previous sources and immediate subsequent recipients of the reportable food after consultation with FDA Must provide amended reports as necessary Must consult with FDA to follow up as necessary Must maintain records related to each report received, notification made, and report submitted to FDA for 2 years

Access to FDA Food Registry Portal http://www.fda.gov/ReportableFoodRegistry

Recall Committee The recall committee is responsible for directing all company communication regarding the recalled product, ensuring that all recalled product has been picked up and responding to all customer questions, concerns and complaints. The recall committee is comprised of the following Get Fresh Produce employees:

Name Jim Costabile Gino Alimondi Rick Buccola Joe Zeno Tom Bachar Olga Gaudin JoAnne Schultz

Title President Vice-President Buyer Buyer Acct Rep Acct Rep Sales Support

Dept. Purchasing Purchasing Operations Operations Sales Sales Sales

Direct Phone 630-417-6648 630-327-5489 630-461-3899 630-220-9987 630-327-5527 630-327-5509 630-514-1203

Product Identification Format Purchase Orders are created for all incoming products. Products are marked when received by the shipper & dated. All products are identified with an inventory code. All products are palletized and stored in lots for rotation into designated locations.



Product Recall Letter See below for samples of the letter(s) to be completed and emailed/faxed to all customers. If a recall is issued on items carried in our warehouse, but our specific product is not affected the INFORMATION ONLY letter would be sent out to customers. If a recall is issued on items carried in our warehouse, and our specific product was affected, the ACTION REQUIRED letter would be sent out to customers indicating proper instruction and procedure as to what to do with the infected product.



Mock Recalls To ensure our ability to source the location of all products that may be recalled and to notify all customers receiving the product within a four (4) hour period, we implement a random Mock Recall at least two times per year, typically in March and August. The Product Recall form is used to note all pertinent information, a staff member is designated to manage the recall procedure and after completion the data gathered from the Mock Recall is filed in the Produce Withdrawal & Recall Procedure Binder.

Emergency Product Safety Food Safety Hazard Potential & Remedy We do not foresee any interruption in cold chain management within our building with the support of an Industrial Back–up Generator, with a redundant back-up protection in place for all systems. In the event that GET FRESH PRODUCE experienced a failure in our Coolers, all products stored in refrigerated coolers held at less than 50 degrees would be moved into another onsite cooler. Temperatures in any cooler can be brought down to accommodate various products.

GET FRESH PRODUCE Corporate Crisis Management Team Name Jim Costabile Gino Alimondi Sharon Costabile

Coordinator of… Inventory Recall Communications


Work Phone 630-665-9665 630-665-9665 630-665-9665

PM Phone 630-417-6587 630-327-5489 630-417-6648


Local Regulatory Agencies EMERGENCY CONTACT LIST GET FRESH PRODUCE: NAME

WORK PHONE

PM PHONE

JIM COSTABILE

630-665-9665

630-417-6587

GINO ALIMONDI

630-665-9665

630-327-5489

SHARON COSTABILE

630-665-9665

630-417-6648

USDA: MR. RICHARD MACKEY:

630-620-7474

FDA: MS. KAREN HIGGS:

312-353-5863

LOCAL CONTACTS: FIRE DEPARTMENT: STATION 1- HEADQUARTERS:

630-837-3701

POLICE DEPARTMENT: EMERGENCY:

9-1-1

NON-EMERGENCY:

630-837-0846

COUNTY BOARD OF HEALTH: DUPAGE COUNTY HEALTH DEPARTMENT

630-682-7400 Reviewed: August 2010



Product Withdrawal and Recall Program (Revised March 2005)

Purpose and Scope: To establish a minimum protocol for the market withdrawal and/or recall of products distributed by GET FRESH PRODUCE.

References: Government Documents 21 CFR Parts 7 & 107 NFPA Bulletin 34-L

Recall Guidelines (7/78) GMA Recall Manual

Definitions: (Note: The following definitions are based on U.S. Regulatory terminology and do not necessarily. And may not completely, be in agreement with International definitions) Consignee – Anyone (customer, wholesaler or broker) who has received, purchased, or used the subject product. Corporate Crisis Management Team – A group of GET FRESH PRODUCE senior management, charged with ultimate responsibility for strategy during a crisis. Correction – the repair, adjustment, re-labeling, or inspection of a product without actually removing it to another location. Depth of Recall – The distribution level of market removal or withdrawal is dictated by the U.S. Regulatory definition of “Class” recall. Class I recalls usually require the most extensive recall efforts including retrieval from consumers and public notification. Class I: Class II: Class III:

Wholesale, retail and consumer levels Wholesale, retail levels Wholesale level

Effectiveness Checks – Documented verification that all accounts that received the product being recalled have been notified and that appropriate action has been initiated. This can be accomplished by direct visits, phone calls, letters, or other means, but must be substantiated to FDA upon request. Effectiveness checks are required by FDA under recall guidelines. Inventory Coordinator – The Inventory Coordinator (Production Manager) supplies the Recall Coordinator with the required inventory information, implements holds of the product still within company control, outlines and implements strategy for returns. Market Withdrawal – Removal or correction of a distributed product which involves a minor violation that would not be subject to legal action, or which involves no violation. Product – Any article subject to the jurisdiction of the FDA, or Foreign national Regulatory Agency (FNRA), including any food, drug or device intended for human or animal use.



Recall – A firm’s removal or correction of a product not under the ownership and control of the producing or distributing company that FDA, or NFRA considers to be in violation of law and against which the Regulatory Agency would initiate legal action. Recalls can be either firm initiated (voluntary) or required by a Regulatory Agency. Recall Classifications – Numerical designation assigned by FDA to a particular product recall to indicate the relative degree of health hazard presented by the product involved Class I:

A situation where there is a reasonable probability that the use of, or exposure to, a volatile product will cause serious adverse health consequences or death.

Class II:

A situation where the use of, or exposure to, a volatile product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Class III:

A Situation where the use of, exposure to, a volatile product is not likely to cause adverse health consequences.

Recall Coordinator – The Recall Coordinator is the President or designated alternative and is charged with executing the recall strategy, communicating results within the company and interfacing with FDA, or regulatory agencies. Recall Strategy – The planned course of action to be taken in conducting a specific recall, which includes the depth of recall, the need for public announcements and the extent of effectiveness checks. Stock Recovery – Removal or correction of an undistributed product that is still under the direct control and ownership of producing and/or distributing company. No portion of the lot has been released for sale or use.

Procedure Recall Procedure – Class I, II, III recalls involving Food Safety issues and Regulatory violations Situation Awareness Information concerning a potential food safety issue or regulatory violation involving a GET FRESH PRODUCE product or raw material is received or discovered by a GET FRESH PRODUCE employee. Information Assessment/ Initial Notifications Involved employee obtains as much information as possible – product name and brand, production code, container size, place and date of purchase, name of consumer (s) or agency involved, nature of complaint and date of occurrence. Employee immediately contacts the Recall Coordinator or designated alternative, and relays the available information. For Imported or Exported products employees notifies Exporting or



Importing Company Recall Coordinator or designated alternative. If it is unclear who should be called then the employee should call: a.) local management b.) President, GET FRESH PRODUCE Preliminary Recall Decision Recall Coordinator evaluates available information, consults with GET FRESH PRODUCE senior management staff, then makes preliminary decision that a recall may be necessary. Product Location/ Containment Recall Coordinator: • Runs reports for production codes associated with the situation. • Contacts the plant production and shipping departments for information and places remaining product on hold. • Provides above information to the Inventory Coordinator who conducts a product accountability analysis to determine if there are any discrepancies. This analysis should include attention to inventory adjustments, destroyed cases, and conversions to other products. • Obtains samples for laboratory analysis (if applicable). Additionally: For exported product – Recall Coordinator relays available information to determine international distribution information. For imported product – Recall Coordinator also contacts the Exporting Company Recall Coordinator and relays available information. Information turnaround should be complete within two hours. NOTE: The receipt of all FAX’S shall be confirmed by phone

Hazard Assessment Recall Coordinator shall contact customer/contact to request a sample analysis and/or confirmation of the potential defect. The following must be investigated/ verified: • Health significance • Existence of process deviation • Special process occurrences • Time period faulty product could be produced • Affected product codes

Recall Strategy Development/ Execution Corporate Crisis Management Team develops recall strategy, in accordance with the elements required by the internal recall classification. See Recall Model Forms section following – these forms may not be appropriate or necessary in situations involving imported or exported products. The strategy must take into account



• • • •

Results of health hazard assessment Ease in identifying the product Obviousness of product deficiency to consumer Continued availability of essential products

And must include: • Depth of recall (Wholesale, retail or consumer levels) • Extent of notification being made to trade or public • Action plan to coordinate removal and return or correction of the product from the marketplace • Status checks/ effectiveness reviews • Recall termination criteria Notification of Regulatory Agencies Recall Coordinator (with concurrence of Corporate Crisis Management team), notifies the appropriate FDA district office as appropriate relating the situation and outlining recall strategy. Execution of the recall plan should proceed while waiting for regulatory confirmation of the plan. See Recall Model Form 4.6 – FDA Notification Status Reports/ Effectiveness Checks Corporate Crisis Management Team issues recall status reports to FDA as required. Recall Coordinator issues any recall effectiveness checks to the FDA as necessary or as required by the regulatory agency. Issues of effectiveness checks or similar interim updates will be coordinated between the Recall Coordinator and the Corporate Crisis Management Team. Recall Termination On completion of the execution of the recall strategy the Recall Coordinator will submit a written recommendation to FDA that the recall be terminated. The recall is not considered over until the Agency sends official notice that the recall is terminated. Product shall not be destroyed without inviting an Agency representative to be present. For imported or exported products the documentation required to terminate a recall will be coordinated between the Recall Coordinator and the contact of the country involved. Recall Coordinator issues instructions to Sales/Marketing to notify accounts of recall termination and authorizes removal of in store recall notices, if any. Recall Coordinator prepares a post recall report summarizing all relevant data and circulates copies to GET FRESH PRODUCE Corporate Crisis Management Team and others as required. Periodic testing of the GET FRESH PRODUCE Product Withdrawal/ Recall Procedures shall be performed at minimum twice per annum.



Recall Model Forms Product Recall Form Product Recall Notification – Information Only Product Recall Notification – Action Required



Mock Recalls Completed MOCK RECALL SCHEDULE (COMPLETED) Month Scheduled

Date Com pleted

Product Recalled

Time Required to Source P & C

March 2003

2/17/2003

Cantaloupe

45 minutes

10/31/2003

Green Onions

60 minutes

1/21/2004

Mesculine Lettuce

75 minutes

September 2003

March 2004 September 2004

March 2005

45 minutes

2/5/2005 Arugula 6/10/2005 Cantaloupe

135 minutes

8/29/2005 Lettuce, Chopped

75 minutes

8/29/2005 Lettuce, Chopped

75 minutes

February 2006

2/10/2006 Celery

90 minutes

March 2006

3/20/2006 Strawberries

155 minutes

5/22/2006 Lettuce 50/50

240 minutes

September 2005

September 2006 March 2007

September 2007 June 2008

July 2008

12/10/2006 Iceless Green Onions

45 minutes

3/1/2007 Leaf Filets

115 minutes

7/2/2007 Green Onions

120 minutes 120 minutes

9/25/2007 Broccoli 6/8/2008 Tomatoes 6x6 bulk

120 minutes

6/8/2008 Tomatoes 6x6 bulk

105 minutes

7/15/2008 Serrano Peppers

90 minutes

7/25/2008 Cilantro

75 minutes

7/28/2008 Jalapeno Peppers

120 minutes

March 2009

3/19/2009 Cantaloupe

120 minutes

June 2009

6/16/2009 Pea Pods

105 minutes

August 2009

8/10/2009 Shredded Lettuce

75 minutes

11/23/2010 Broccoli Florettes

75 minutes

November 2009 February 2010

2/10/2010 Spinach

90 minutes

February 2010

2/22/2010 Red Onion

137 minutes

April 2010

4/30/2010 Spinach

75 minutes

August 2010

8/10/2010 Cilantro

70 minutes



Actual Recalls Completed

ACTUAL RECALLS Recall Date

Date Com pleted

Product Recalled

Time Required to Source P & C

1/26/05

1/26/2005

Green Onions

75 minutes

6/6/05

6/6/2005

Cole Slaw

90 minutes

9/22/06

9/22/2006

Spinach

180 minutes

Ginger Root

150 minutes

Cello Spinach

120 minutes

8/10/07 5/2/09

8/10/2007 5/2/2009



Customer Complaints Procedure for Filing Complaints Although we hope that we will not have many situations where we cannot amicably resolve specific customer problems, at times it may be necessary for the customer to have a Procedure for filing complaints. Our company procedure for filing complaints begins with the Customer REPORTING their issue to Customer Service Staff. The customer’s concern is directed to the Customer Service Manager as the first step. If the Manger or CSR’s are unable to resolve the complaint, the Manager or CSR then sends an email describing the complaint to the Sales representative for follow up. The sales representative addresses the issue directly with the customer and can forward the resolution to customer service if needed. If these steps are unsuccessful, and it becomes obvious that the issue cannot be addressed internally or there is a problem of a more serious nature, the company may choose to bring in an officer of the company as an intermediary to identify what steps need to be taken to find a resolution. Once the Officer recommends a course of action for complicated problems, management will discuss the action and notify the customer in writing of the final decision regarding what the company is willing to do to resolve the customer’s problem.

INTERMEDIARIES OF RECORD Jim Costabile, President, 630-417-6587 cell; Gino Alimondi, Vice President 630-327-5489 cell; Sharon Costabile, Business Mgr, 630-417-6648 cell Mark Siegel, Legal Counsel, Labor Issues, Caffarelli & Siegel, Ltd., Phone: 312-782-3550, Fax: 312-782-3505 Michael Cotteleer, Legal Counsel, Business Issues, Cotteleer & Associates, Phone: 630-6684200 Michael Hartman, CPA, FGMK, Phone: 847-374-0400, Fax: 847-374-0420

New Procedure for Logging Complaints New procedure established in June 2008 with software upgrade for logging Customer complaints/returns & follow-ups in Produce Pro. After logging the complaint in the system, Sales staff or CSR sends out the appropriate communication to Get Fresh departments to allow for monitoring progress and follow through. Reports will be run and reviewed on a weekly basis.



Revised: June 2008



Customer Complaints Report



Product Withdrawal Recall Procedures Manual - Illinois

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