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Letter to Sunland Inc. Concerning Suspension of Food Facility Registration; Notice of Opportunity for Hearing

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 DEPARTMENT OF HEALTH & HUMAN SERVICES                      Public Health Service

  Food and Drug Administration 
 Silver Spring, MD 20993

 

November 26, 2012

Jimmie D. Shearer, President
Sunland Inc.
42593 U.S. Highway 70
Portales, NM 88130-9043

Dear Mr. Shearer:
 

The U.S. Food and Drug Administration (FDA) hereby suspends the registration for your food facility, Sunland, Inc. (Sunland), located at 42593 U.S. Highway 70, Portales NM. Your food facility was registered with FDA pursuant to section 415(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 350d(a)] on November 24, 2003, and such registration was updated on July 11, 2012. Section 415(b)(1) of the FD&C Act provides in relevant part that if FDA determines that food manufactured, processed, packed, received, or held by a facility registered under section 415 has a reasonable probability of causing serious adverse health consequences or death to humans or animals, FDA may by order suspend the registration of a facility (1) that created, caused, or was otherwise responsible for such reasonable probability; or (2) that knew of, or had reason to know of, such reasonable probability, and packed, received, or held such food.

As discussed further below, FDA has determined that food manufactured, processed, packed, received, or held by your facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, and that your facility created, caused, or was otherwise responsible for such reasonable probability. FDA is issuing this Order under section 415(b)(1) of the FD&C Act, and the Order is effective immediately upon your receipt. While this Order is in effect, pursuant to section 415(b)(4) of the FD&C Act, no person can import or export food into the United States from your facility, offer to import or export food into the United States from your facility, or otherwise introduce food from your facility into interstate or intrastate commerce in the United States. The introduction or delivery for introduction into interstate commerce in violation of this Order is a prohibited act under section 301(d) of the FD&C Act [21 U.S.C. 331(d)], subject to injunction proceedings under section 302 of the FD&C Act [21 U.S.C. 302] and certain penalties under section 303 of the FD&C Act [21 U.S.C. 333]. This Order also offers you an opportunity to request an informal hearing, as provided by section 415(b)(2) of the FD&C Act.


The basis for FDA’s determination is as follows:

  • In September 2012, the Centers for Disease Control and Prevention (CDC) and FDA collaborated to investigate a multistate outbreak of Salmonella Bredeney. Since that time, CDC has reported a total of at least 35 persons infected with the outbreak strain of Salmonella Bredeney from 19 states; eight of these persons were hospitalized as a result of their infection. Trader Joe’s™ brand Valencia Creamy Salted peanut butter made with Sea Salt has been identified by FDA and CDC as a likely source of this outbreak.
  • Salmonella, including Salmonella Bredeney, is a pathogenic organism that has a reasonable probability of causing serious adverse health consequences or death to humans.
  • Sunland is the sole manufacturer of Trader Joe’s™ brand Valencia Creamy Salted peanut butter made with Sea Salt.
  • As discussed in detail below, evidence collected by FDA in response to this outbreak, including your facility’s own testing records, environmental and finished product samples analyzed by FDA, and observations made by FDA during an inspection of your facility, establishes the following:
    • Nut butter and nut products manufactured, processed, packed, and held by your facility are contaminated with Salmonella, or are at risk for contamination with Salmonella, based on the conditions in your facility. Your facility’s testing records over the past 3 years include multiple positive Salmonella results throughout your facility and in finished product. Due to this contamination and/or risk for contamination, FDA has determined that these products have a reasonable probability of causing serious adverse health consequences or death to humans.
    • Your facility created, caused, or was otherwise responsible for this reasonable probability. Specifically, FDA has determined that the conditions within your facility (e.g., the presence of Salmonella in various locations throughout the facility and CGMP violations that could lead to cross-contamination between raw materials and finished product) caused this reasonable probability.

Sunland Samples:

  • From September 17, 2012 to October 16, 2012, FDA inspected your facility, located at 42593 U.S. Highway 70, Portales NM. During this time, we primarily inspected two buildings at your facility - the building in which you manufacture, process, pack, and hold nut butter products (nut butter building) and the building in which you manufacture, process, pack, and hold shelled and in-shell peanut products (nut building). During the inspection, FDA investigators obtained copies of your testing records.
  • FDA reviewed your testing records of finished product samples and environmental samples collected from your facility between June 2009 and September 2012. Your facility sent these finished product samples and environmental samples for analysis to (b)(4), a third party private laboratory. During this time, your records indicate that this third party testing identified the presence of Salmonella spp. in at least 40 finished products from 11 finished product lots of nut butter products consisting of multiple brands and eight (8) sets of environmental samples (generally 17 swabs each set) with at least one positive swab from each set. These results reveal that food manufactured, processed, packed, and held at your facility is contaminated with Salmonella.
  • Your facility distributed at least a portion of eight (8) lots of peanut and almond butter consisting of multiple brands manufactured between March 01, 2010 and September 2012, after composite testing of those lots revealed the presence of Salmonella. Specifically, when composite testing of a lot was positive for Salmonella, individual containers of product from the positive tested lots were re-tested and portions, or all, of these lots were distributed based on the re-test (non-composite) testing. The initial Salmonella positive composite test results were disregarded. At least one of the batches from a lot with initial positive composite test results, manufactured on July 14, 2012, that was ultimately distributed, contained a Pulsed Field Gel Electrophoresis (PFGE) pattern that was indistinguishable from the clinical isolates for the outbreak strain Salmonella Bredeney. When a PFGE pattern of an isolate is indistinguishable from the pattern of another isolate from a common source, it is highly likely that the two isolates are the same strain of Salmonella Bredeney. These results demonstrate that food manufactured, processed, packed, and held by your facility has a reasonable probability of causing serious adverse health consequences or death to humans.

FDA Samples:

  • As part of our inspection, FDA collected environmental samples from different areas of your facility, including the roasting room in your nut butter building and equipment located inside the roasting room and various areas in your nut building. FDA performed analytical testing of those environmental samples, which identified 4 swabs that tested positive for Salmonella Bredeney and 24 swabs that tested positive for other Salmonella species, including samples that FDA collected from the roasting room and equipment located inside the roasting room in your nut butter building and samples that FDA collected from your nut building.
  • Analysis using PFGE showed that Salmonella Bredeney isolates obtained from the FDA environmental samples collected on September 24, 2012, from the roasting room of your nut butter building were indistinguishable from the clinical isolates associated with the Salmonella Bredeney outbreak.
  • In addition, as part of our inspection FDA collected samples of nut and nut butter finished products. FDA performed analytical testing of these finished product samples which identified thirteen peanut butter products and one raw peanut product that tested positive for Salmonella, including five peanut butter products that tested positive for Salmonella Bredeney. Analysis using PFGE showed that Salmonella Bredeney isolates obtained from four of the finished peanut butter product samples were indistinguishable from the clinical isolates associated with the Salmonella Bredeney outbreak. Some of these samples were collected from lots of product that were released for sale to the public. These results also indicate that the pervasive and widespread nature of Salmonella contamination in Sunland’s peanut butter processing building and adjacent peanut plant caused Salmonella contamination in finished product, which indicates a reasonable probability of these products causing serious adverse health consequences or death in humans.

Current Good Manufacturing Practice (CGMP) Violations:

  • During FDA’s investigation, our investigators observed serious violations of our Current Good Manufacturing Practice (CGMP) regulation for food in your facility’s food production environment. These violations cause your ready-to-eat nut butter and nut products to be adulterated within the meaning of section 402(a)(4) of the FD&C Act, in that the foods have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. Further, these conditions and practices create a reasonable probability that finished product that is manufactured, processed, packed, and held by your facility is contaminated with Salmonella and therefore that there is a reasonable probability of finished product causing serious adverse health consequences or death to humans.
  • Specifically, our investigators observed the following:
    • A number of conditions and practices in your facility likely result in cross-contamination between raw peanuts and peanuts that have been roasted or brined. This is particularly problematic because raw peanuts are more likely to contain pathogenic bacteria, particularly Salmonella, and can introduce pathogenic bacteria into finished product. Specifically:
      • Your (b)(4) brand packaging equipment in the small packaging room of the nut building is not effectively cleaned to prevent contamination between raw and roasted peanuts.
      • Your facility’s “(b)(4) Sacks,” collapsible mesh totes used to store and transport nuts around the facility, are considered multi-use because they carry raw peanuts, roasted and/or brined peanuts, and peanut food waste. The “(b)(4) Sacks” are not cleaned and sanitized between uses. This is problematic because it likely results in cross-contamination between raw peanuts and peanuts that have been roasted or brined.
      • The nut building does not have any hand washing sinks in the production or packaging areas. Five employees were observed having bare hand contact with ready to package, roasted, in-shell peanuts in the Picking Room of the nut building. Hand washing sinks are essential in preventing cross-contamination between raw peanuts and peanuts that have been roasted or brined.
      • Your three compartment sink was observed leaking and water was observed accumulating onto the floor in the nut butter building.
      • Dead legs were observed on six pipe connections on your processing equipment in the nut butter building, which allows food material to accumulate. These areas act as collection points for debris and water, both of which facilitate the growth of pathogenic bacteria that could spread to finished product.
      • Uneven welds were observed on your processing equipment in the nut butter building. The welds were not smooth to facilitate cleaning and sanitizing of the equipment.

We acknowledge your written response to the FDA Form 483 that was issued at the end of our most recent inspection of your facility, received by FDA on November 9, 2012. In your response, you indicate a number of corrective actions that you plan to take in response to FDA’s observations; however your response omits significant details regarding planned physical repairs and corrective actions, and the adequacy or effectiveness of these corrective actions cannot be determined based on the information provided in the response. It will be necessary for FDA to evaluate the completed corrective actions on site to assure their adequacy. Based upon the current condition of the facility and past management policies and actions, FDA concludes that unless and until Sunland has completed and implemented certain corrective actions, food manufactured, processed, packed, received, or held by Sunland has a reasonable probability of causing serious adverse health consequences or death to humans or animals.

Opportunity for an Informal Hearing

Pursuant to section 415(b)(2) of the FD&C Act, your facility is being offered an opportunity for an informal hearing on the actions required for reinstatement of your facility’s registration and why your facility’s registration should be reinstated.

Section 415(b)(2) of the FD&C Act provides in relevant part that a registrant subject to an order of suspension under section 415(b) shall be provided with an opportunity for an informal hearing, to be held as soon as possible, but not later than two (2) business days after the issuance of the order. In order to request an informal hearing to be held within two (2) business days after the issuance of this Order, you must submit your request, in writing, to the FDA contact person identified in this Order within one (1) business day after the issuance of this Order.

A request for a hearing may not rest upon mere allegations or denials, but must present specific facts showing that there is a genuine and substantial issue of fact that warrants a hearing. Pursuant to 21 CFR 16.26, a request for a hearing may be denied, in whole or in part, if the Commissioner or her delegate determines that no genuine and substantial issue of fact had been raised by the material submitted. A hearing will not be granted on issues of policy or law. Accordingly, your request for a hearing should include information that you believe shows that there is a genuine and substantial issue of fact that warrants a hearing, and must be submitted in writing to the FDA contact person identified in this Order.

Alternatively, section 415(b)(2) of the FD&C Act provides that an informal hearing may be held at some other time period, as agreed upon by FDA and the registrant. In order to request a hearing to be held at a later time, as agreed upon by the registrant and FDA, you must submit your request, in writing, to the FDA contact person identified in this Order within three (3) business days after issuance of this Order. If you do not submit a written hearing request within three (3) business days after the issuance of this Order, your facility will be deemed to have waived its right to the opportunity for an informal hearing.

If you request an informal hearing, a Presiding Officer (PO) as defined in 21 CFR 16.42 will be designated and you will be notified of that individual’s identity and contact information. The PO may deny your request for a hearing if the PO determines that you have not raised a genuine or substantial issue of fact by the material submitted in your hearing request, or if you failed to request the hearing within the time frame stated in this Order. If the PO determines that a hearing is not justified, written notice of a determination will be given to the registrant and FDA explaining the reasons for denial of the hearing. If the PO grants your request for an informal hearing, at the informal hearing you will have the opportunity to address the actions required for reinstatement of your facility’s registration and to explain why the registration should be reinstated. The informal hearing will be conducted in accordance with the procedures in 21 CFR part 16, Regulatory Hearing Before the Food and Drug Administration, to the extent that such procedures are not in conflict with the procedures specified in section 415(b) of the FD&C Act. The informal hearing will be closed to protect information not available for public disclosure, as provided by 21 CFR 16.60.

If you wish to request an informal hearing, but do not wish to request that the hearing be held orally, you should contact the FDA contact person identified in this Order and send a written response containing the basis for your request to the FDA contact person within three (3) business days. Your submission should state that you waive your opportunity for an oral informal hearing and that you want your request to be based on your written response and other information available to the agency.

Under section 415(b)(4) of the FD&C act, if the registration of a facility is suspended under section 415(b), no person shall import or export food into the United States from such facility, offer to import or export food into the United States from such facility, or otherwise introduce food from such facility into interstate or intrastate commerce in the United States. Accordingly, until this Order is vacated and your facility’s registration is reinstated, you or any other individual may not introduce food from your facility, which includes all of the buildings at your facility, into interstate or intrastate commerce in the United States. This prohibition includes food produced before your receipt of this Order that is currently still under your control. This Order does not affect your on-going recall of peanut and peanut butter products and shipments of such products back to your facility. However, once you have received the returned food products, you may not introduce such products from your facility into interstate or intrastate commerce.

If you do not wish to appeal this Order or request an oral informal hearing, but wish to have your registration reinstated in part by submitting a corrective action plan to FDA that demonstrates how you plan to correct the conditions found by FDA, please contact the FDA contact person identified in this Order.

You may submit your written request for an informal hearing or your written response containing the basis for your appeal of this Order by any mode of written communication (e.g., mail, email, delivery service, personal delivery) to, or may otherwise contact, the designated FDA contact person using the following contact information:

LaTonya M. Mitchell, District Director
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
LaTonya. Mitchell@fda.hhs.gov
303-236-3016

In your submission, you should include your mail address, phone number, email, and any other relevant contact information. You should promptly contact the FDA contact person by phone or email if you have any questions regarding this Order.
 

Sincerely,

/s/

Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs