Inspections, Compliance, Enforcement, and Criminal Investigations
Nicho Produce Co., Inc. 5/21/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
May 21, 2012
UPS OVERNIGHT MAIL
Dionicio G. Villarreal, Owner/President
Tomas R. Villarreal, Treasurer/Director
Nicho Produce Company, Inc.
925 N. 10th Avenue
Edinburg, Texas 78541
Dear Messrs. Villarreal:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your produce processing facility, located at 925 N. 10th Avenue, Edinburg, Texas, from December 9 through December 16, 2011. FDA conducted this inspection in response to recalls of your "Cut Above" brand shredded bagged lettuce and spinach products that were associated with samples #1111745 (lettuce) and #1112788 (spinach), collected and analyzed by the U.S. Department of Agriculture (USDA), that yielded Listeria monocytogenes (L. monocytogenes).
During the inspection, we performed environmental sampling (FDA sample #641168) which, as discussed in more detail below, identified the presence of L. monocytogenes at your facility, including on direct food-contact surfaces. In addition, we documented serious violations of the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Food (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations and the finding of L. monocytogenes in your facility cause the produce products processed in your facility to be 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)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and FDA's regulations through links on FDA's home page at http://www.fda.gov.
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. Immune compromised individuals and unborn fetuses are particularly susceptible to listeriosis.
During the inspection, FDA investigators collected an environmental sample (FDA sample #641168) that consisted of 72 environmental swabs from your processing room. Analysis of twelve swabs yielded L. monocytogenes, including Sub 30 (top of plastic block used to hold perforated bucket used to collect dewatered lettuce, which is a direct food-contact surface), Sub 31 (bottom of drier spinner, which is a direct food-contact surface), and Sub 36 (squeegee used to clean packaging table and other flat table top surfaces, which is a direct food-contact surface). One of the isolates was indistinguishable from the strain that was isolated by USDA in your spinach product as analyzed with pulsed-field gel electrophoresis (PFGE). The rest of the isolates are PFGE matches of another USDA isolate from two bags of lettuce. A summary of the PFGE results from these samples is included for your information.
We acknowledge that you recalled produce products associated with USDA samples #1111745 and #1112788 and FDA sample #641168. However, FDA isolated L. monocytogenes from several different locations in your facility. Those isolates are PFGE matches for produce products indicating that cross contamination likely occurred from direct or indirect contact with processing room surfaces.
The investigators' observations were presented to you on form FDA-483, lnspectional Observations, at the conclusion of our inspection on December 16, 2011.
The inspection revealed the following violations:
1. As required by 21 CFR 110.80(b)(2), your food manufacturing, including packaging and storage, must be conducted under conditions and controls necessary to minimize the potential for the growth of microorganisms or for the contamination of food. However, our investigators observed the following during the inspection:
• On December 10, 2011, an employee wearing gloves held a red shovel over the water tank of the flume system as he cleaned debris from the catch pan under the dewatering belt. The employee touched the bottom of the shovel while shoveling water and debris into a trash can. The employee proceeded to dump a perforated bucket containing cut and washed lettuce onto a packaging table where he mixed the lettuce, without washing or sanitizing his gloved hands.
FDA investigators subsequently environmentally swabbed the shovel referenced above. A swab taken from the shovel, FDA sample #641168, Sub 47, yielded L. monocytogenes.
• On December 10, 2011, an employee at packaging table 5 was observed holding a squeegee while taking plastic bags from a cart in the kitchen. The employee packed the ready-to-eat cut lettuce in the bags and put his hands through the chute to press down the ready-to-eat product. At no time during this process did the employee wash or sanitize his gloved hands.
FDA investigators subsequently environmentally swabbed the shovel referenced above. A swab taken from the squeegee, FDA sample #641168, Sub 36, yielded L. monocytogenes.
We have reviewed your responses to the FDA-483 dated December 19, 2011 and January 23, 2012. In both responses, you stated that you have increased your sanitation efforts and implemented more stringent employee training. Your responses are inadequate because you did not include any supporting documentation of your corrective action.
In your January 23, 2012 response, you further stated that on January 20, 2012, you conducted environmental microbial swab testing to ensure that all areas in question no longer pose any possible risk to your production line. You stated that "all testing results were negative for Listeria." However, we cannot judge the adequacy of your statement because you did not provide us with your sampling plan and sampling results. We will evaluate the adequacy of any proposed corrective action during our next inspection of your facility.
2. As required by 21 CFR 110.35(a), you must conduct cleaning and sanitizing of utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. However, prior to production on December 10, 2011, our investigators observed broccoli florets on an (b)(4) cutting machine after the machine had been cleaned and sanitized. Additionally, prior to production on December 13, 2011, our investigators observed food residue on the shaft of a dewatering belt and on a catch pan after the equipment had been cleaned and sanitized, We have reviewed your responses to the FDA-483 dated December 19, 2011 and January 23, 2012. In your December 19, 2011 response, you stated that you were implementing more training and documentation of sanitation procedures after each processing run. Your response is inadequate because you did not include any supporting documentation of your corrective action. We will evaluate the adequacy of any proposed corrective action during our next inspection of your facility.
3. As required by 21 CFR 110.37(b)(4), your facility's plumbing must be adequately installed and maintained to provide adequate floor drainage where normal operations release or discharge water or other liquid waste on the floor. However, on December 10 and December 13, 2011, standing water was observed in various locations of the processing room, which has only one common drain. Standing water permits L. monocytogenes to grow and spread.
We have reviewed your responses to the FDA-483 dated December 19, 2011 and January 23, 2012. In your January 23, 2012 response, you stated that "all drain and plumbing issues have been resolved." Your responses are inadequate because you did not include any supporting documentation of your corrective action. We will evaluate the adequacy of any proposed corrective action during our next inspection of your facility.
4. As required by 21 CFR 110.20(b)(4), your facility must be constructed in such a manner that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials. However, on December 10, 2011, our investigators observed condensate underneath the cooling fan unit in the processing room during the processing of lettuce with a "use by" date of December 20, 2011. Our investigators observed that the cooling fan was positioned approximately 10 feet above the water flume system and was blowing towards packaging table 4 where lettuce was being packaged.
We have reviewed your responses to the FDA-483 dated December 19, 2011 and January 23, 2012. In your December 19, 2011 response, you stated that the condensate observed by our investigators was produced by your use of a steam pressure wash. You also stated that you plan to use window washing cloths to remove excess condensate produced by the steam pressure wash. Our findings of L. monocytogenes on your equipment and on direct food-contact surfaces demonstrates that your procedures were not effective for control of L. monocytogenes. In your January 23, 2012 response, you stated that you are using "industry grade Steam Pressure Equipment" for cleaning.
We note that, in our Draft Guidance for Industry, Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods, we recommend against indiscriminate use of high-pressure hoses in cleaning. We also recommend against use of high-pressure water hoses in areas where refrigerated or frozen ready-to-eat foods are processed, exposed during production, or after equipment has been cleaned and sanitized. Usage of a pressure wash can create aerosols that spread L. monocytogenes.
Our draft guidance is intended to help industry control L. monocytogenes. It may be helpful to consult our recommendations in the draft guidance, which is available at:
We will evaluate the adequacy of any proposed corrective action during our next inspection of your facility.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. It is your responsibility to assure that your facility operates in compliance with the Act and all applicable regulations.
You should take prompt action to correct the violations cited in this letter and prevent their recurrence. Failure to do so may result in enforcement action by FDA without further notice, including seizure and/or injunction.
Within fifteen (15) working days from your receipt of this letter, please notify this office in writing of the specific steps you have taken to correct all of the violations described above. Include in your response documentation to show that correction has been achieved. Your response should also describe the methods and controls you have implemented or will implement to prevent the recurrence of these violations. If you cannot complete all corrections within 15 working days, please state the reason for the delay and the date by which you will complete the corrections.
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 reinspection related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31 (a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
Please send your written reply to this letter to Elvia Cervantes, Compliance Officer, U.S. Food and Drug Administration, 4040 N. Central Expressway, Suite 300. Dallas, Texas 75204. If you have any questions concerning this letter, please contact Compliance Officer Cervantes at (214) 253-5236 or by e-mail at email@example.com.
Reynaldo R. Rodriguez, Jr.
Dallas District Office