Monday, September 12, 2016

FDA Issues Warning Letter to RTE Facility with LM Issues

FDA issued a warning letter to a Saranac Foods for an inspection completed in February.  We have seen a number of similar type of Warning letters issued.  In this one, inspectors found LM in a facility making RTE product, and  then conditions that would support the spread of that organism (issues with hose usage, condensation, and airflow).  While the company did respond, the response was lacking in terms of a 'complete' corrective action.
 
Listeria
FDA found 3 of 89 samples positive for Listeria monocytogenes. all non-contact but in the ready-to-eat pasta and deli salad production room.
  1. Floor near food carts and the 2-compartment sink;
  2. The floor alongside of the interior legs of stand mixer;
  3. An area of the floor under the 1-compartment sink where a leak is present.
Although the company took corrective action, the FDA stated: FDA is unable to evaluate the adequacy of your response because it does not provide specific details of your corrective actions and steps taken to prevent contamination of food. 
  
GMP Issues
1) An employee was observed using a water hose to spray the floor in the Southeast corner of the processing area near where bulk food ingredients were being stored in plastic containers. .....The water from the floor aerosolized on impact and sent water particles and debris from the floor into the air. All the food containers were covered in water and visible adhering debris. In addition, two of the six containers labeled as containing citric acid and (b)(4) were not sealed tightly and were open and exposed to the atmosphere.
 
The company took corrective action, but FDA responded: "However, the response did not address re-training employees on cleaning operations or raw material storage. Lastly, your response does not indicate whether the raw materials observed during the inspection were evaluated and removed from the processing area or if the bulk materials remained in-process in the facility for use in production."
  
2) "...observed the ceiling in the processing area to be in disrepair in that the ceiling appears to be rusting underneath the paint. In these areas, cracks are starting to form and the underlying material is to the point where it could flake away from the ceiling. We also observed condensate dripping from the processing area ceiling where exposed product was being packed."
 
FDA Response to the corrective action taken "...you did not address the issue of repair of the ceiling in the processing area that was observed in disrepair during the inspection. You did provide information in your response that the packaging area located where the ceiling was in disrepair is no longer in use and has been relocated to another part of the facility. However, we are unable to evaluate the adequacy of your response because it does not provide documentation and specific details of your steps taken to prevent contamination of food."
 
3) "...failed to provide adequate ventilation or operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food, food packaging materials, and food-contact surfaces, as required by 21 CFR110.20(b)(6). On 02/02/2016, we observed the (b)(4) pressure cooker release steam into the Cooking Room and observed condensate droplets form on the ceiling directly above the uncovered steam kettles. We also saw condensate on the ceiling of the same area "
 
FDA response to the corrective action taken  "...without further documentation we are unable to determine if the fans are adequate to remove the moisture and prevent the condensation buildup. Your response states pasta will be covered during the cool down process to avoid any condensation from falling into the pasta. This corrective action does not prevent moisture from entering the kettle of cooked pasta during the steps of the process we observed in which the kettles are uncovered, cold water is added, and an employee stirs the cooked pasta and water.   Lastly, your response does not state whether or not the kettles observed with condensate were cleaned and sanitized prior to production. "
  
 
  
 
 
FDA Warning Letter
Saranac Brand Foods, Inc. 8/12/16
 
Public Health Service
Food and Drug Administration
Detroit District
300 River Place
Suite 5900
Detroit, Ml 48207
Telephone: 313-393-8100
FAX: 313-393-8139 
 
WARNING LETTER 2016-DET-16
August 12, 2016
   
VIA UPS
 
Mr. Dennis M. Nowak, President
Saranac Brand Foods, Inc.
60 South Bridge Street.
Saranac, MI 48881
 
Dear Mr. Nowak:
 
The U.S. Food and Drug Administration (FDA) inspected your ready-to-eat cold salad, sauce, and dip manufacturing facility located at 60 South Bridge Street, Saranac, MI 48881 on February 1-9, 2016. During the inspection, FDA collected environmental samples from various areas in your processing facility including areas that are in close proximity to food and food contact surfaces. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen,in your ready-to-eat pasta and deli salad production room.During our inspection, FDA investigators observed violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110).[1] Based on FDA’s analytical results for the environmental sampling and inspectional findings documented during the inspection, we determined that your food products are 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 in FDA’s home page at www.fda.gov.
 
We acknowledge your firm’s February 19, 2016, response to the FDA-483, which includes a description and photos of corrections to the observations noted on the FDA-483. Your corrective actions are addressed below in relation to each of the noted violations.
 
Environmental Sampling
FDA laboratory analysis of the environmental samples collected from various locations at your firm’s processing facility on February 1, 2016, confirmed that three (3) of the eighty nine (89) environmental swabs were positive for L. monocytogenes. The positive L. monocytogenes swabs were taken from non-food contact surfaces including the floor near food carts and the 2-compartment sink; the floor alongside of the interior legs of stand mixer; and an area of the floor under the 1-compartment sink where a leak is present.
 
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. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Therefore, it is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism. Consuming these contaminated foods can lead to a severe, sometimes life-threatening illness called listeriosis, an atypical foodborne illness, which is a major public health concern, due to the severity of the disease, its high case-fatality rate, long incubation time, and tendency to affect individuals with underlying conditions.
 
In addition, L. monocytogenes is able to colonize a variety of moist surfaces such as floors, floor drains, and processing equipment, and may persist in other niches. It can collect in condensation, standing water and food residues. L. monocytogenes is particularly hardy because of its tendency to form biofilms, which are protective environments that shield the bacteria from ordinary cleaning processes and allows them to survive even in extreme conditions. Strict in-plant sanitation measures must be instituted to eliminate the organism or prevent its growth.
 
On March 10, 2016, FDA informed you of these results. FDA acknowledges your verbal corrective actions to the environmental samples; however, FDA is unable to evaluate the adequacy of your response because it does not provide specific details of your corrective actions and steps taken to prevent contamination of food.
 
Good Manufacturing Practices
FDA investigators observed serious violations of the Current Good Manufacturing Practice regulation for foods [21 CFR Part 110]. Your significant violations were as follows:
 
1. You failed to take reasonable precautions to ensure that production procedures do not contribute contamination from any source, as required by 21 CFR 110.80. Specifically, on 02/02/2016, an employee was observed using a water hose to spray the floor in the Southeast corner of the processing area near where bulk food ingredients were being stored in plastic containers. The bins were labeled sugar, salt, dehydrated onion, (b)(4) (sodium benzoate), (b)(4) (preservative mixture), and citric acid. The water from the floor aerosolized on impact and sent water particles and debris from the floor into the air. All the food containers were covered in water and visible adhering debris. In addition, two of the six containers labeled as containing citric acid and (b)(4) were not sealed tightly and were open and exposed to the atmosphere.
 
As discussed above, FDA laboratory analyses of the environmental swabs found the presence of L. monocytogenes on the floor in multiple locations in close proximity to food and food-contact surfaces in your facility.
 
In your February 19, 2016 written response, you detail that your firm replaced storage containers that seal better and educated employees on using low pressure water to avoid overspray. However, the response did not address re-training employees on cleaning operations or raw material storage. Lastly, your response does not indicate whether the raw materials observed during the inspection were evaluated and removed from the processing area or if the bulk materials remained in-process in the facility for use in production.
 
2. Your plant is not maintained in a sanitary condition or kept in repair sufficient to prevent food from becoming adulterated as required by 21 CFR 110.35(a). Specifically, on 02/02/2016, investigators observed the ceiling in the processing area to be in disrepair in that the ceiling appears to be rusting underneath the paint. In these areas, cracks are starting to form and the underlying material is to the point where it could flake away from the ceiling. We also observed condensate dripping from the processing area ceiling where exposed product was being packed.
 
We acknowledge your written response to the observation, however you did not address the issue of repair of the ceiling in the processing area that was observed in disrepair during the inspection. You did provide information in your response that the packaging area located where the ceiling was in disrepair is no longer in use and has been relocated to another part of the facility. However, we are unable to evaluate the adequacy of your response because it does not provide documentation and specific details of your steps taken to prevent contamination of food.
 
3. Your firm failed to provide adequate ventilation or operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food, food packaging materials, and food-contact surfaces, as required by 21 CFR110.20(b)(6). On 02/02/2016, we observed the (b)(4) pressure cooker release steam into the Cooking Room and observed condensate droplets form on the ceiling directly above the uncovered steam kettles. We also saw condensate on the ceiling of the same area on 02/01/2016. During the inspection, management described the cooling process and stated that pasta was cooked and cooled in the steam kettles on 02/01/2016.
 
Water (e.g., steam vapor) originating from inadequately ventilated process operations can also provide adequate surface (e.g., equipment, overhead pipes, and ceilings) moisture for L. monocytogenes to persist and spread. Condensates originating from inadequately cleaned surfaces over processing lines present a known high risk for product contamination in processing environments where L. monocytogenes has been found.
 
Your written response states you plan to increase ventilation in the cook room by using both ventilation fans when the product is being cooked and cooled; however, without further documentation we are unable to determine if the fans are adequate to remove the moisture and prevent the condensation buildup. Your response states pasta will be covered during the cool down process to avoid any condensation from falling into the pasta. This corrective action does not prevent moisture from entering the kettle of cooked pasta during the steps of the process we observed in which the kettles are uncovered, cold water is added, and an employee stirs the cooked pasta and water. Lastly, your response does not state whether or not the kettles observed with condensate were cleaned and sanitized prior to production.
 
This letter is not intended to be an all-inclusive statement of the violations that exist at your firm. You are responsible for ensuring that your firm is operating in compliance with all the requirements of the Act, and all applicable regulations, including the Current Good Manufacturing Practice regulation [21 CFR Part 110]. Your firm should take prompt action to correct the violations addressed in this letter. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
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.
 
In addition, we note that during an inspection conducted in June 2014 by the Michigan Department of Agricultural and Rural Development (MDARD), the state collected environmental swabs and identified the presence of L. monocytogenes in your facility. The environmental sampling results highlight the need to better control L. monocytogenes in your firm’s environment. We recommend that you reassess your firm’s cleaning and sanitation operation.
 
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover re-inspection-related costs.
 
Your firm’s response should be sent to: LCDR Kelli Wilkinson, Compliance Branch, Food and Drug Administration, District Office, 300 River Place Suite 5900 Detroit, MI 48207. If you have any questions about the contents of this letter, please contact: LCDR Kelli Wilkinson, Compliance Officer, at 313-393-8120.
 
Sincerely,
/S/
Art Czabaniuk
District Director
Detroit District Office

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