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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Franklin Foods Inc. 1/13/11


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

New England District 

One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700 
FAX: (781) 596-7896
VIA United Parcel Service
January 13, 2011
Mr. Jon Gutknecht
Franklin Foods, Inc.
6274 Linton Blvd
Delray Beach, FL 33484
Dear Mr. Gutknecht:
On September 16, 2010 through October 26, 2010, the Food and Drug Administration (FDA) inspected your food processing facility, Franklin Foods, Inc., located in Enosburg Falls, Vermont. We found that your firm has serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, regarding the manufacturing of smoked salmon cream cheese.
In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and to implement a HACCP plan that complies with this section, or to otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)].
Accordingly, smoked salmon cream cheese products manufactured by your firm are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
We acknowledge your written response to the 2010 inspection received by our New England district on November 9, 2010. The agency has reviewed your response; however, your response is inadequate in that it fails to adequately address how the critical control point of refrigerated storage will be controlled through the continuous monitoring system your response states has been installed at your facility, including evidence to show this system has been installed, calibrated and functioning properly.
Your response also fails to include details of how you will reassess your current Listeria monitoring program. Specifically, it fails to state how updating the sampling criteria from (b)(4) environmental swabs to (b)(4) environmental swabs being collected (b)(4) will adequately reveal potential contamination in your facility or in your products. In addition, it fails to outline the steps taken to swab more product contact areas and perform a more diverse sampling of your facility’s manufacturing environment.  
Your significant violations are as follows:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). However, your firm’s HACCP plan for smoked salmon cream cheese does not list the food safety hazard of Clostridium botulinum.
In addition, your HACCP plan for smoked salmon cream cheese does not list the food safety hazard of food allergens. Your products include allergenic substances such as milk products, Consequently, FDA recommends that your HACCP plan identify these as hazards and include a monitoring strategy that includes review each lot of labels to ensure that the allergenic substances are included on the labels.  
2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c)(4). However, your firm’s revised HACCP plan for smoked salmon cream cheese does not list the monitoring frequency at the “storage” critical control point to control pathogens. This monitoring procedure provides no information related to the temperature conditions of the products during extended refrigerated storage. FDA recommends continuous monitoring and recording of storage temperatures on a 24 hour a day/7 day a week basis with a daily check of the temperatures and the equipment.
3. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for smoked salmon cream cheese at the “storage” critical control point to control pathogens is not appropriate. For example, your firm’s HACCP Plan for “Salmon Cream Cheese” included in your response lists “Research/Document Root Cause and solution within one week” as a corrective action for the critical control point of “Salmon Cooling/Storage.” This does not ensure the specific causes of deviations from this critical control point are investigated and addressed adequately. Further, it does not prevent the distribution of potentially unsafe product.
Additionally, FDA analysis of environmental swabs collected at your facility during the inspection found the pathogen Listeria monocytogenes (L. monocytogenes) in two locations at your facility (underneath the (b)(4) Processors and on the wall near the (b)(4) Processor.) Your response was not adequate. The findings of L. monocytogenes on non-food contact surfaces are of concern in conjunction with the insanitary conditions (e.g., flies, splashing water.)
L. monocytogenes, which can grow at refrigeration temperatures, is a pathogenic bacterium that can contaminate foods, resulting in a mild illness called listerial gastroenteritis or a severe, sometimes life-threatening, illness called invasive listeriosis.   Immune-compromised individuals, the elderly and unborn fetuses are particularly susceptible to listeriosis. FDA recommends that your sanitation controls include effective environmental monitoring programs designed to identify and eliminate and/or control pathogens such as L. monocytogenes in and on surfaces and areas in the facility where contamination could result in food product contamination. Specifically, strict in-plant sanitation measures need to be instituted to eliminate L. monocytogenes or prevent its proliferation in a food-processing establishment. If your environmental monitoring program detects the presence of Listeria spp. in the processing facility, you should institute immediate corrective actions including intensified cleaning and sanitizing operations, and further testing to ensure L. monocytogenes does not occur in finished product.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.

We request that you notify this office in writing, within 15 working days from your receipt of this letter, of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulations (21 CFR Part 123) and the Current Good Manufacturing Practice regulations (21 CFR Part 110). You also have the responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Todd J. Maushart, Compliance Officer, One Montvale Ave, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Mr. Maushart at 781-596-7844.
Mutahar S. Shamsi
District Director
New England District
Mr. John Ovitt
General Manager
Franklin Foods, Inc.
East Street
P.O. Box 486
Enosburg Falls, VT 05450