| Public Health Service Food and Drug Administration |
| New York District 158-15 Liberty Avenue Jamaica, NY 11433 |
Department of Health and Human Services
January 7, 2011
WARNING LETTER NYK-2011-12
VIA U.P.S. Overnight Mail
Avelardo Carrera, President
Azteca Linda Corp.
d.b.a. Queso El Azteca
898 Flushing Avenue
Brooklyn, New York 11206
Dear Mr. Carrera:
The U.S. Food and Drug Administration (FDA) inspected your cheese manufacturing facility located at 898 Flushing Avenue, Brooklyn, New York between June 7 - 8 and 23 - 24, 2010, and August 24 - September 3, 2010. On June 7, 2010 and August 25, 2010, FDA collected environmental samples from multiple areas in your processing facility. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen. In addition, FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for food, Title 21, Code of Federal Regulations, Part 110 [21 CFR Part 110]. These violations and our findings of a recurrent strain of L. monocytogenes in your processing facility cause your ready-to-eat cheese products 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 can find the Act, the CGMP regulation for foods through links in FDA's home page at www.fda.gov.
L. monocytogenes is a pathogenic bacterium that is widespread in the environment. It can proliferate in food processing facilities without proper controls, where it may contaminate food. Consuming these contaminated foods can lead to a severe, sometimes life-threatening illness called listeriosis, an atypical foodborne illness of major public health concern due to the severity of the disease, its high case-fatality rate, long incubation, and predilection for individuals with underlying conditions.
Nine environmental swabs collected on June 7, 2010 from your facility tested positive for L. monocytogenes. These swabs were collected from: a cracked and pitted floor with standing water directly beneath the stainless steel Queso Fresco table #1 which is located along the west wall of processing room; the stainless steel wall on the right side above the stainless steel Queso Fresco table # 2 which is located along the West wall of the processing room; standing water in the cracked and missing floor tile on the floor next to Queso Fresco table # 2; standing water in the cracked and pitted floors beneath the pasteurizer near the North West corner of the processing room; broomstick bristles of the black broom in the North East corner of the processing room; inside and underneath the black dust pan stored in the North East corner of the processing room; standing water in front of the exit door on the North wall of the processing room; the area between and underneath the right side of Queso Fresco table #1; and the area between and underneath the left side of Queso Fresco table #1.
In addition, three environmental swabs collected on August 25, 2010 from your facility tested positive for L. monocytogenes. These swabs were collected from: the surface of the front edge of the stainless steel Queso Fresco production table #1 located along the West wall of the processing room; the surface of the front edge of the stainless steel Queso Fresco production table #2 located along the West wall of the processing room; and the area between and underneath the stainless steel Queso Fresco production table #2 after the table top was removed for cleaning (left side). L. monocytogenes found in the environment of your facility increases the risk of your finished product becoming contaminated.
Analysis using Pulsed Field Gel Electrophoresis ("PFGE") showed that L. monocytogenes isolates obtained from the FDA environmental samples collected on June 7, 2010, and August 25, 2010, were indistinguishable by both a primary and secondary enzyme. When a PFGE pattern of an isolate is indistinguishable from the pattern of another isolate from a common source, it is highly likely that two isolates are the same strain of L. monocytogenes. These PFGE results suggest that L. monocytogenes may have been transported throughout your facility and established niche areas. The presence of a persistent strain of L. monocytogenes in your facility over time is significant in that it demonstrates that sanitation efforts were inadequate to remove this pathogenic organism.
We also note that the Rhode Island Department of Health reported the following finished product samples as positive for L. monocytogenes: Queso El Azteca brand of “Queso Fresco (Fresh White Cheese)” with the expiration dates of 9/11/10 and 9/12/10; and Queso El Azteca brand of “Requeson (Ricotta Cheese)” with the expiration date of 9/19/10.
We acknowledge that your firm voluntarily recalled products found to contain L. monocytogenes and products manufactured on the dates of FDA’s environmental sampling. We also acknowledge that your firm stopped all production in an attempt to clean and sanitize your facility. Based on the most recent FDA inspection, however, it is apparent that your firm continues to operate under insanitary conditions which may reasonably cause contamination of the processing facility and finished product with L. monocytogenes. Once established in a production area, humans or machinery can facilitate the pathogen’s movement to and contamination of food-contact surfaces and finished product.
FDA investigators also observed the following significant violations of the Current Good Manufacturing Practice regulation for foods [21 CFR Part 110]:
1) You failed to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food-contact surfaces as required by 21 CFR 110.35(a).
Specifically, on August 26, 2010 an employee cleaning large stainless steel bowls used to hold ready-to-eat queso fresco did not use sanitizer after the bowls were cleaned with a mild detergent.
In addition, on June 7, 2010 a production employee was observed washing the stainless steel Queso Fresco tables with a high pressure hose next to the Queso Herba cooling tanks where Queso Herba was being temporarily held to cool. The spray from the hose resulted in creating an aerosol from the dirty table in close proximity to the exposed product. We acknowledge that cleaning operations may now be conducted when there are no food products in the processing room. However, please note that using a high pressure hose for cleaning, sanitizing, or rinsing operations may cause the spread of any pathogens in your processing facility.
2) You lacked effective hand sanitizing preparations in accordance with 21 CFR 110.37(e)(2).
Specifically, on August 26, 2010 the Investigator measured your sanitizer’s concentration of your only hand sanitizing dip station located in the processing room. Our measurement revealed 0 ppm of sanitizer solution, as well as a heavy accumulation of product residue in the hand sanitizer dip. In addition, an employee wearing latex gloves was observed to be forming and shaping ready-to-eat queso fresco with his gloved hands in the processing room, he then touched the soiled cheese mixer with his gloved hands, and then without washing his gloved hands he dipped his gloved hands into the 0 ppm hand sanitizing solution and then immediately handled the ready-to-eat queso fresco. We acknowledge your manager’s statement that you have installed a pre-concentrated hand sanitizer pump to ensure the same concentration of sanitizer is present each time an employee uses the pump.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, and the Current Good Manufacturing Practice regulation [21 CFR Part 110]. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please respond in writing within fifteen (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.
Please send your reply to the Food and Drug Administration, Attention: Dean R. Rugnetta, Compliance Officer, 300 Pearl Street, Suite 100, Buffalo, New York 14202.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating. If you have questions regarding any issue in this letter, please contact Mr. Rugnetta at (716) 541-0324.
Sincerely,
/s/
Ronald M. Pace
District Director
New York District
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