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U.S. Department of Health and Human Services

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Universal Blanchers LLC Response Letter

UNIVERSAL BLANCHERS

SEABOOK INGREDIENTS

 

June 22, 2009


Sherrie L. Krolczyk, Compliance Office
Food and Drug Administration
Dallas District
4040 North Central Expressway
Dallas, TX 75204-3145

Dear Ms. Krolczyk:

Please accept this correspondence as acknowledgement of our receipt of the Warning Letter issued by FDA dated June 9, 2009. As an update, please note that with his recent retirement Michael Fisher is no longer serving as Chief Executive Officer of Universal Blanchers/Seabrook Ingredients. James Lee Fenn, III is now serving as Chief Operating Officer and shall be the corporate contact.

We would like to stress our understanding of the need to comply with FDA regulations, and as such, we have performed a systematic analysis and review of our entire Food Safety Program (UB LLC Quality, Standard Operating Procedures, Good Manufacturing Practices, Sanitation, and Maintenance Programs) in an effort to adequately and thoroughly address all of the observations detailed in Form FDA 483 dated February 18-26, 2009. Our response is formatted as to first present corrective action(s) to the observations pointed out in the Warning Letter on pages 2 and 3, followed by the corrective action(s) to other observations detailed in Form FDA 483 that were referenced but not repeated in the Warning Letter.

As stated in the first paragraph on page 2 of the Warning Letter, one of the eight positive subsamples was pulled from the floor area near our roaster intake area. The FDA investigators swabbed the concrete expansion joints in this area.

Corrective Action: Upon identification of this area as a niche area, which we understand to be an area that has moisture, heat, and protein, we removed all expansion joint fillings from this area and thoroughly sanitized the area with (b)(4) (a (b)(4) sanitizer; label enclosed) followed by (b)(4). Once dry, our Maintenance Department then re-sealed these areas with joint filler. We determined the source of the moisture for this niche area was from our roaster (b)(4) cleaning; therefore, we now make every effort to minimize moisture in this area, and once the roaster cleaning procedure is completed and the area is dried, we treat it with (b)(4) sanitizer/disinfectant; label enclosed). We incorporated (b)(4) into our sanitizer rotation since Dr. Don Zink, PHD, Senior Food Scientist CFSAN/FDA, noted it was the premier sanitization chemistry for Salmonella during our conference call with the FDA on March 11, 2009.

Also referenced in the first paragraph on page 2 is the lack of a physical barrier between raw peanut handling and roasted peanut packaging. The raw peanut handling area mentioned here is our raw peanut holding bin that is positioned such as to feed the intake area of our roaster.

Corrective Action: All parties agreed that installing a physical barrier here was an opportunity to improve our operation. We have researched different designs for a barrier that will provide the separation function yet still be functional in terms of sanitation and maintenance in the area. We are currently evaluating the final two designs that we feel are best suited for this application, and we intend to have the final design fabricated and installed within the next 60 days.

Upon receiving the positive Salmonella results on March 5, 2009, Universal Blanchers put all roasted finished product ON HOLD (ON HOLD Procedure enclosed; Micro-Testing Procedure and Temporary Hold Procedure enclosed). Our Quality Assurance Team immediately initiated a thorough cleaning and sanitizing of these specific areas. Following this sanitation, we initiated our Environmental Testing Procedure (Environmental Testing Procedure enclosed). In order to also immediately enhance and bolster our Environmental Testing Program, we increased the number of swabs taken per zone as illustrated in our Environmental Testing Locations and Procedures (Environmental Testing Locations and Procedures enclosed), and we increased the frequency of testing from (b)(4) to (b)(4). John Stein, Director of Quality Assurance, discussed, reviewed, and challenged our environmental programs and philosophies in numerous telephone conversations and e-mail exchanges with (b)(4) of (b)(4) (b)(4) has a working knowledge of this operation due to the Micro Kill Step Validation Study he conducted on our roaster in 2006). (b)(4) has over forty years of experience working in the food industry and is experienced in environmental monitoring, design, and sanitation efficacy program development. (b)(4) is also a HACCP Certified Lead Instructor overseeing special projects, process validations, HACCP plan validations, and inoculated pack studies. John also discussed with (b)(4) their methodology for Salmonella Serotyping ((b)(4) SOP enclosed) and Listeria Speciation ((b)(4) SOP enclosed). These findings, coupled with (b)(4) insight, imparted upon us the importance of not only broadening our view in terms of the facility as a whole but more importantly to focus more intently on those areas that could be classified as nooks and crannies.

As a company, Universal Blanchers/Seabrook Ingredients is utilizing this experience as a springboard to further educate ourselves in a variety of areas including but not limited to Plant Sanitation, HACCP, Maintenance, and Good Manufacturing Practices. The following section represents our continuing educational efforts.

• Jim Fenn, COO, attended the APC Spring Conference in Washington, D.C. on March 10-13, 2009 where Dr. Zink was a speaker. During Dr. Zink’s presentation, he emphasized the importance of identifying any area that has moisture that never dries immediately or completely plus heat plus protein because that combination of components support microbes, especially Salmonella.

• Cathy Kleinhans, Quality Control Manager, and Jason Morris, Pest Control and Food Safety Officer, attended AIB Food Plant GMP / Sanitation Workshops on April 21-22, 2009 in Lubbock, Texas. The two-day meetings were customized to meet peanut industry needs. The training session were facilitated by AIB instructors and covered the following topics:

o U.S. Food Regulations, Origins and Social Perspectives
o Introduction to the Fundamental Prerequisite Programs
o Developing and Implementing a Sanitation Program
o Integrated Pest Management for Food Plants
o Sanitary Design Criteria
o Personnel Practices: GMP’s Part 110.10
o Foreign Material Control Programs
o Allergen Control Program
o Food Defense Overview & Vulnerability Assessment
o Preventive Maintenance
o HACCP Overview

• John Stein, Director of Quality Assurance, and Rick Boyce, Director of Technical Services for Seabrook Ingredients, attended HACCP for Peanut Processors, sponsored by The University of Georgia (College of Agricultural & Environmental Sciences, Department of Food Science and Technology) and the American Peanut Council with accreditation by the International HACCP Alliance on May 5-6, 2009 in Athens, Georgia.

Speakers participating included:

o Dr. William C. Hurst, University of Georgia and accredited HACCP Instructor
o Dr. Karina G. Martino, University of Georgia Food Science Extension Outreach Program
o Steve Calhoun, American Peanut Council Food Safety Consultant
o Special Session: Participants reviewed the results of a research study on thermal inactivation of Salmonella sponsored by the American Peanut Council and the importance of using this information for validation of conditions used in their own processes for the control of Salmonella.

• During the week of June 1, 2009, Cathy Kleinhans, Quality Control Manager, participated in a four day (b)(4) seminar presented by the National Confectioners Assoc. titled Nut Handling & Processing for Confectioners and Small Nut Processors.

Speakers included:

o Dr. Michael Doyle, UGA Regents Professor of Food Microbiology Director, Center for Food Safety
o Dr. William Hurst, University of Georgia, accredited HACCP instructor
o Dr. Steven Goodfellow, Deibel Labs, HACCP Certified Lead Instructor
o Tom Mackie, Food Safety Consultant to NCA
o Steve Calhoun, Food Safety Consultant to APC

(b)(4), will be traveling to our facility in Dublin, Texas in August 2009. He is highly experienced in identifying microbiological, quality, and food safety issues and devising solutions to minimize their impact. (b)(4) expertise includes thorough knowledge of food safety risks associated with all aspects of processing cocoa, chocolate and confectionary, dairy, nuts, sugars, ice cream, and proteins, and he has expert knowledge of measures to prevent food pathogens in environments/finished products. He has traveled worldwide to solve microbiological problems and is a certified NFPA-SAFE Auditor. (b)(4) is also trained and experienced in the design and evaluation of HACCP Programs. While on-site, he will evaluate our current Environmental Programs for both strengths and weaknesses, and he will critique our Quality Team as they execute their Environmental Testing Procedure.

In order to complement our 2006 Micro Kill Step Validation Study, we hired (b)(4), Food Technologist and Representative of (b)(4) based in (b)(4), who conducted a Roaster Mapping on June 4, 2009 (Micro Kill Step Validation Study and Roaster Mapping enclosed). Optimal air/heat distribution was documented throughout the width and depth of the peanut bed.

The corrective action(s) listed below correlate with the FDA investigators’ observations outlined in the Warning Letter on pages 2 and 3.

1a Corrective Action: Elevator was cleaned on February 27, 2009. This elevator will be cleaned (b)(4) under normal operating conditions ((b)(4)). Frequency of elevator will increase to mirror production increases. This procedure is stated on the Master Sanitation Schedule (Master Sanitation Schedule enclosed).

1b Corrective Action: The roaster was thoroughly dry cleaned February 19-21, 2009. The interior of the roaster was wet cleaned March 6-8, 2009. The interior of the oven was then dried and sanitized with (b)(4). The roaster's interior and exterior will be dry-cleaned (b)(4) by the Roaster Operator. This procedure is stated on the Master Sanitation Schedule (Master Sanitation Schedule enclosed).

1c When FDA arrived at our facility on February 18, 2009, our routine plant sanitation was being performed, but our employees were instructed to halt all activities and remove themselves to the Breakroom. The roaster brush had not been cleaned at this point, and peanut meal, which was brown in color, was noted.

Corrective Action: The roaster brush has been added to the Master Sanitation Schedule (Master Sanitation Schedule enclosed). The brush will be cleaned (b)(4) by the Roaster Operator, who will initially remove any loose peanut meal from the roaster brush and then use a sanitized scrub brush to remove any adhering peanut meal. The Roaster Operator will then spray both the roaster brush and scrub brush with(b)(4) Disinfectant ((b)(4)) sanitizer for food contact surfaces; label enclosed).

2a Corrective Action: On March 21, 2009, brush seals were installed on the loading doors to close the gaps between the roll-up doors and floor in the roasting plant for protection against pests and to comply with 21 CFR 110.35(c).

2b Corrective Action: On March 28, 2009, Maintenance Department installed new doors on Air Handlers (b)(4) and (b)(4). These doors seal tightly and provide protection against pests.

The gap in the screen in Air Handler (b)(4) was repaired on February 19, 2009.

*We would like to offer additional insight to the statement, “on 2/18/09, FDA investigators observed forty-two (42) rodent pellets inside Air Handler (b)(4).” All parties discussed this observation at the point of observation. We explained to the investigators that we felt what they were viewing was peanut skins and fines, which are particulates that can accumulate during ordinary operating conditions. The investigators collected a sample of the material in question that all parties examined together in our production lab. The debris observed was small and dark brown, but we explained that we did not feel that it was rodent pellets. The investigators initially retained a sample of this material, but after much deliberation, they disposed of the sample. Jason Morris, Facility Pest Control and Food Safety Officer, (Texas Department of Agriculture/Structural Pest Control Service License No:((b)(4)), confirmed that the suspect rodent pellets were indeed peanut particulates.

3 On February 20, 2009, the FDA investigators observed an accumulation of peanut skins on the ground between the blanching and roasting plants. These peanut skins are particulates that can accumulate during ordinary operating conditions, but they are not utilized as mulch. 

Corrective Action: Although we were making a concerted effort to maintain the cleanliness of this area, we have added the duty of monitoring and cleaning this area to the Master Sanitation Schedule with responsibilities appointed to the Oven and Roaster Operators.

The corrective action(s) listed below pertain to other observations that were referenced but not repeated in the Warning Letter.

Form FDA 483 (02/26/09)
OBSERVATION 1

FDA investigators observed a buildup inside the roasting (b)(4) oven.

Corrective Action: Please refer to the detail in “1b”

Form FDA 483 (02/26/09)
OBSERVATION 2
FDA investigators observed a buildup of peanut meal on the buckets and chain on the elevator for the sorter bin in the roasting plant.

The elevator discussed in this observation is the elevator that feeds the finished product packaging bin.

Corrective Action: Elevator was cleaned on February 27, 2009. This elevator will be cleaned (b)(4) under normal operating conditions ((b)(4)). Frequency of elevator cleaning will increase to mirror production increases. This procedure is stated on the Master Sanitation Schedule (Master Sanitation Schedule enclosed).

Form FDA 483 (02/26/09)
OBSERVATION 3
FDA investigators observed a failure to provide adequate screening or other protection against pests.

Corrective Action: Please refer to the detail in “2a” and “2b”

Form FDA 483 (02/26/09)
OBSERVATION 4
FDA investigators observed a failure to remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, with the immediate vicinity of the plant buildings or structures

Corrective Action: Please refer to the detail in “3”

Form FDA 483 (02/26/09)
OBSERVATION 5
FDA investigators observed that the potable water from the well that supplies the chiller system at the blanching plant and the well that supplies water for the roasting plant was cross-connected with the chiller water supply. They observed that there were no backflow prevention devices installed on the water supply for these (b)(4) chillers.

We have (b)(4) separate wells at our location, (b)(4) for the blanching plant and (b)(4) for the roasting plant. We have (b)(4) separates chilling systems, (b)(4) for the blanching plant and (b)(4) for the roasting plant. At the time of the FDA investigators’ observance, we did not have backflow prevention devices on the water supply for (b)(4) of the separate chilling systems.

Corrective Action: On March 21, 2009, testable backflow prevention devices were installed on the water supply for the (b)(4) separate chilling systems, (b)(4) for the blanching plant and (b)(4) for the roasting plant. These devices will be tested (b)(4).

Form FDA 483 (02/26/09)
OBSERVATION 6
FDA investigators observed an employee that did not wash his hands thoroughly in an adequate handwashing facility.

Corrective Action: On February 27, 2009, Cathy Kleinhans, Quality Control Manager, conducted a formal GMP Training Session emphasizing the importance of properly washing hands, at which time she presented the employees our Hand Washing Policy (Hand Washing Policy enclosed). In addition, our Maintenance Department installed hand sanitizers at each sink.

Form FDA 483 (02/26/09)
OBSERVATION 7
FDA investigators observed the improper mixing of the (b)(4) solution used as a sanitizing agent.

Corrective Action: Following the observation made by the FDA investigators, all previously mixed bottles were emptied. The use of (b)(4) as a sanitizer has been discontinued. We are now using (b)(4) (a quick drying disinfectant (b)(4) surface sanitizer for food contact surfaces; label enclosed). For nonproduct surfaces, we are now using (b)(4) a (b)(4) disinfectant. We also revised our Mixing Procedures for Sanitizing Solutions (Mixing Procedures for Sanitizing Solutions enclosed).

Form FDA 483 (02/26/09)
OBSERVATION 8
FDA investigators observed toilet doors that open into areas where food is exposed to airborne contamination.

Corrective Action: Although not enclosed, there is a wall partition directly in front of the restrooms in the roasting plant. When you exit either restroom, you are forced to step onto a footbath and then to a hand washing station. We are currently reviewing several designs for the construction of a separation corridor that would isolate this area. We plan to have this remodeling project completed within the next 60 days.
Form FDA 483 (02/26/09)

OBSERVATION 9
FDA investigators observed that a women’s toilet tank cover was missing in one of the toilets. The other toilet was not is working condition. They also observed that one toilet had an uncovered trash container, and the other toilet did not have a trash container.

Corrective Action: Women’s toilet water tank cover was replaced on March 2, 2009. The other toilet was repaired on February 24, 2009. Covered trash containers are in place.

Form FDA 483 (02/26/09)
OBSERVATION 10
FDA investigators observed an oily substance, sticky to the touch, adhering to the outside surface of the roaster between cooking zones (b)(4) through (b)(4).

Corrective Action: The piece of equipment referenced in this observation is our roaster. When FDA arrived at our facility on February 18, 2009, our routine plant sanitation was being performed, but our employees were instructed to halt all activities and remove themselves to the Breakroom. We returned to dry cleaning the interior of the roaster on February 18, 2009 and completed the interior cleaning on February 22, 2009. Upon completion of these exercises on February 23, 2009, we resumed the process of roasting peanuts.

In conclusion, we trust that you find the corrective action(s) presented satisfactory, and we welcome your feedback regarding their adequacy. We are committed to addressing all of the issues observed by the FDA investigators stated in both the Form FDA 483 and Warning Letter. Our goal and objective is to comply with all FDA laws and regulations and as such shall continue to protect the public health of the consumer through utilization of recognized and approved Food Safety policies and procedures.

Sincerely,

/s/


Thomas Kevin Gaines
VP of Southwest Operations
Universal Blanchers/Seabook Ingredients
P.O. Box 198; Highway 6 West
Dublin, TX 76446