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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Gills Onions, LLC 1/23/13

  

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

Public Health Service
Food and Drug Administration
 Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
 
Telephone:      949-608-2900
FAX:            949-608-4415

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE                                                                     
SIGNATURE REQUIRED
 
January 23, 2013                                                                                                             
WL# 16-13
Steven H. Gill, Partner
Gills Onions, LLC
1051 Pacific Avenue
Oxnard, CA, 93030-7254
 
Dear Mr. Gill:
 
The U.S. Food and Drug Administration (FDA) collected a sample of Gills Onions “Fresh Diced Yellow Onions” product at a retail establishment on July 5, 2012. On August 27, 2012 we collected a sample of Gills Onions “3/8" Diced Yellow Onion” product at a wholesale establishment. Both samples yielded isolates of Listeria monocytogenes (L. monocytogenes) that are indistinguishable by Pulsed Field Gel Electrophoresis (PFGE) analyses. The presence of L. monocytogenes in your products causes them to be adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §342(a)(1)] in that they bear or contain a poisonous or deleterious substance which may render them injurious to health.
 
We collected these finished product samples as a follow-up to our May 30 through June 1, 2012 inspection of your onion and celery manufacturing and distribution facility, located at 1051 Pacific Avenue, Oxnard, California. During the inspection, FDA investigators collected an environmental sample (FDA sample # 722304) that consisted of 167 environmental swabs from various locations in your facility. Analysis of thirteen swabs yielded L. monocytogenes, including two swabs collected from food contact surfaces. The PFGE analysis determined that all thirteen swabs yielded isolates of L. monocytogenes that were indistinguishable from the isolates that we isolated from your finished products. 
 
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans or equipment.  Consumption of food contaminated with L. monocytogenes can result in a mild illness (called listerial gastroenteritis) or a severe, sometimes life-threatening illness called invasive listeriosis.  Invasive listeriosis occurs predominantly in older adults and persons with impaired immune systems. Listeriosis in pregnant women is typically a mild “flu-like” illness, but can result in fetal death, premature labor, or neonatal infection. 
 
We note that the finished products that were positive for L. monocytogenes were processed after your firm had conducted corrective action to clean your facility and eliminate L. monocytogenes from the processing facility. Our findings demonstrate that the corrective action your firm took was inadequate, that your facility has a harborage problem, and that your celery and onion products are adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. §342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.
 
We acknowledge your firm conducted voluntary recalls on May 5; July 17; July 24 and September 6, 2012 as a result of findings of L. monocytogenes in finished products by the Canadian Food Inspection Agency, FDA and the California Department of Public Health. We also acknowledge that you reported making corrective actions in your letters and submissions on June 12; June 16; June 24; August 2; August 29, and September 18, 2012. We have also reviewed your September 28, 2012 letter addressed to the California Department of Public Health in which you reported making extensive structural and operational corrective actions. We have the following ongoing concerns:
  • You found Listeria species on a food contact surface during a validation run after making renovations and repairs to building 5 (retail area). In response to the positive finding you replaced the piece of equipment and sanitized the surrounding area. You resumed production on the line on September 18, 2012.  Because you are processing commodities that may be contaminated with Listeria in the field, FDA recommends that you develop a plan to control for Listeria which may come in on raw product as well as a corrective action plan to prevent Listeria that comes in on product from colonizing the facility.
  • Your letter states that once a month you collect swabs from food contact surfaces during production. FDA recommends that you collect swabs from food contact surfaces during production at least weekly to allow you to take corrective action before Listeria colonizes your equipment and facility. In Section XVI of FDA’s draft guidance entitled Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods; Draft Guidance, we recommend measures to monitor critical surfaces and areas to detect locations that harbor Listeria species or L. monocytogenes.   FDA also recommends that you have a written environmental monitoring plan for Listeria that includes corrective actions you will take upon finding samples that are positive. Our draft guidance is available at: http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/foodprocessinghaccp/ucm073110.htm.
 
The above violations are not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that your products are in compliance with the Act and all applicable regulations, including the Current Good Manufacturing Practice regulation for foods [21 CFR Part 110].
 
You should take prompt action to correct the violations cited in this letter. Failure to do so may result in enforcement action by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
 
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection related costs from the responsible party for the domestic facility.  The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection related costs.
 
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should describe any additional corrections that you have made since your September 28, 2012 letter to the California Department of Public Health. We also request that you contact this office within fifteen (15) working days to arrange a meeting to discuss your facility repairs, sanitation standard operating procedures (SSOPs), revisions to your Listeria control plan, and our ongoing concerns.
 
Please send your written reply to this letter to the U.S. Food and Drug Administration, Attention: David Whitman, Compliance Officer, at the address above.  To arrange the meeting please contact Compliance Officer Whitman at 619-941-3769 or via email at david.whitman@fda.hhs.gov.
 
 
Sincerely,
/S/                                                                               
Alonza E. Cruse, Director
Los Angeles District
 
Cc:
 
Ms. Ingeborg Small, Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS 7602
P.O. Box 997435
Sacramento, CA 95899-7435