| Public Health Service Food and Drug Administration |
| Central Region New Jersey District Waterview Corporate Center 10 Waterview Blvd., 3rd Floor Parsippany, NJ 07054 Telephone (973) 331-4906 |
Department of Health and Human ServicesMarch 3, 2011
OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
11-NWJ-13
Mr. Emilio Cuautle
President
Queseria Chipilo, Inc.
61 Willet Street, Bldg. F 2nd Floor
Passaic, NJ 07055
Dear Mr. Cuautle:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, Queseria Chipilo, Inc., located at 61 Willet Street, Bldg. F 2nd Floor, Passaic, New Jersey, on August 9 through August 18, 2010, August 26 through September 23, 2010, and October 25 through November 8, 2010. FDA collected sample number 640332, Que Sabroso Oaxaca String Cheese, 14 oz, Code: CHIPILO NOV 10 2010, during the August 9 through August 18, 2010 inspection. Laboratory analysis confirmed the presence of Listeria monocytogenes, a human pathogen, in your packaged ready-to-eat (RTE) finished product Oaxaca String Cheese, rendering the product 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 it contains a poisonous or deleterious substance which may render it injurious to health.
Listeria monocytogenes (L. monocytogenes) is a pathogenic bacterium that is widespread in the environment. It can be isolated from soil, silage and other environmental sources and can also be found in man-made environments such as food processing establishments where it can grow at refrigeration temperatures. Any moist area, such as your cheese production area, can harbor L. monocytogenes. It can proliferate in food processing facilities without proper controls, where it may contaminate food. Consuming these contaminated foods can result in a mild illness (called listerial gastroenteritis) or cause a severe, sometimes life-threatening, illness called invasive listeriosis. Immune compromised individuals and unborn fetuses are particularly susceptible to listeriosis. In the past, RTE cheese products have been implicated in outbreaks of invasive listeriosis.
FDA also collected sample numbers 553621, 640330, and 640331, consisting of sixty-nine environmental swabs taken from food contact surfaces and non-food contact surfaces during the August 9 through August 18, 2010 inspection. Laboratory analyses of these environmental swabs detected the presence of L. monocytogenes in the following seven areas in your facility:
• INV 553621; (Zone 1) Sub 23, food contact surface, inside base of red bin where string cheese is placed.
• INV 640331; (Zone 1) Sub 52, food contact surface, top surface of measuring scale located on table # 2 (production area).
• INV 640331; sub 48 (Zone 2), cracked and depressed floor located adjacent to floor drain hole.
• INV 640331; sub 49 (Zone 2), interior edge of the production room floor drain.
• INV 640331; sub 66 (Zone 2), right bottom floor of refrigerator # 1 located adjacent to cheese rack trolley.
• INV 640330 sub 37 (Zone 2), front left wheel of the white salt bin located adjacent to commercial strip curtain.
• INV 640330 sub 38 (Zone 2), Floor of the production area located adjacent to two round metal kettles.
Pulsed Field Gel Electrophoresis (PFGE) testing results showed that seven L. monocytogenes isolates obtained from the environmental swabs collected from your facility in August 2010 had an identical PFGE pattern with an isolate obtained from your finished product Que Sabroso Oaxaca String Cheese. This is significant· because the seven swabs were collected from multiple different locations in your production area, from food contact and non-food contact surfaces; indicating that L. monocytogenes was transported throughout your facility and was reasonably likely to contaminate food.
Furthermore, during our inspections, we observed significant violations of the Current Good Manufacturing Practice (CGMP) regulations for food manufacturers (Title 21, Code of Federal Regulations (CFR), Part 110). Based on these violations and on the results of the laboratory analysis of the environmental swabs collected during the August 9 through August 18, 2010 inspection, we have determined that your cheese products are adulterated within the meaning of Section 402(a)(4) of the Act, [21 U.S.C. § 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or been rendered injurious to health.
You may find the Act and the CGMP regulations for food through links in FDA's home page at www.fda.gov.
The significant violations documented during the inspections include the following:
1. Failure to maintain buildings, fixtures, and other physical facilities of the plant in a sanitary condition and kept in repair sufficient to prevent food from becoming adulterated within the meaning of the Act. Failure to conduct cleaning and sanitizing of utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. 21 CFR 110.35(a).
Specifically, the following observations were made during the October 25 through November 8, 2010 inspection:
A) In the production area, a yellow pipe was observed with filth accumulation running across the ceiling above an uncovered, portable electric cheese mixer which we observed to contain unpackaged in-process curd. In addition, the yellow pipe and fiberboard ceiling tiles were observed exposed to steam during production, resulting in condensate dripping from the pipe near the electric cheese mixer.
B) A piece of wet plastic covering the cheese extruder's panel was observed in close proximity to RTE string cheese.
C) A dirt covered extension cord was hanging from a gap in the drop ceiling tiles directly above personnel that were handling exposed RTE cheese products.
D) Louvers on two exhaust fans in the production area were covered with a dirty film. In addition, the exhaust fans in the windows lacked adequate screening to prevent the entry of pests and filth contamination from the outside of the plant. Please note that in addition to the requirement under 21 CFR 110.35(a) that you keep buildings, fixtures, and other physical facilities in repair sufficient to prevent food from becoming adulterated, 21 CFR 110.35(c) also requires that effective measures be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests.
E) White handled knives were stored throughout the production area when not in use, including on a wet packaging table and in a white bin containing liquid. These knives were used to open packages of curd mozzarella and to cut RTE string cheese without first being cleaned or sanitized.
2. Failure to ensure that food-contact surfaces be corrosion-resistant when in contact with food, and made of nontoxic materials and designed to withstand the environment of their intended use. 21 CFR 110.40(a). Specifically, during the October 25 through November 8, 2010 inspection, a non-food-grade plastic pail with a pitted metal handle was observed being used to collect hot water for the production of string cheese.
3. Failure to adequately install and maintain plumbing to avoid creating an unsanitary condition, 21 CFR 110.37(b)(3), and to provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor, 21 CFR 110.37(b)(4).
Specifically, the following observations were made during the October 25 through November 8, 2010 inspection:
A) A drain in the Men's restroom was clogged and caused stagnant water to accumulate onto the floor adjacent to bathroom stalls. Employees were observed walking from the bathroom to the production area and tracking the water with their rubber boots from the bathroom to the production area.
B) Water from the production of Oaxaca String Cheese was not adequately draining and had been pooling around a concrete divider. The concrete divider in the middle of the floor causes an obstruction and prevents the flow of excess water to the drain, causing the accumulation of water. In addition, a drain adjacent to the concrete wall had been clogged with large pieces of cheese products and other debris, which prevented the flow of water into the drain.
Furthermore, the following observation was made during the August 9 through August 18, 2010 inspection:
A) Employees were observed sweeping excess water into a single drain located in the center of the production room causing it to splash on their clothing, aprons, and food contact surfaces. L. monocytogenes was detected in swabs taken on the interior edge of the production room floor drain.
4. Failure to take all reasonable measures and precautions to ensure that all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, 21 CFR 110.10(b), including wearing outer garments suitable to the operation in a manner that protects against the contamination of food, 21 CFR 110.10(b)(1), and by washing hands thoroughly (and sanitizing if necessary) after each absence from the work station, 21 CFR 110.10(b)(3).
Specifically, the following observations were made during the October 25 through November 8, 2010 inspection:
A) Aprons used by employees who work in direct contact with food were observed being stored in the women's restroom unprotected from contamination.
B) An employee was observed rolling RTE string cheese against an apron which was cut through, thereby exposing the product to the employee's clothes. In addition, this apron was later hanging adjacent to a garbage container in the production area.
C) Aprons used by employees who work in direct contact with food were observed to be placed in a raw material bin containing packages of whole milk mozzarella curd used to produce RTE Oaxaca string cheese. The aprons were in contact with the insanitary outer surface of the bin.
D) Employees were observed leaving the production area wearing their aprons and gloves, returning to the production area and then handling RTE string cheese without cleaning and sanitizing their hands, gloves, and aprons.
Furthermore, the following observations were made during the August 9 through August 18, 2010 inspection:
A) Employees' aprons were stored next to a squeegee stick in the production room. Employees' aprons were also observed hanging on top of a hose adjacent to the 3-compartment sink.
B) Employees were observed leaving the production area wearing their aprons and gloves and returning without cleaning and sanitizing their hands or changing aprons.
5. Failure to have seams on food-contact surfaces be smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms. 21 CFR 110.40(b).
Specifically, the following observation was made during the August 9 through August 18, 2010 inspection, and again during the October 25 through November 8, 2010 inspection: The interior seam weld in the middle of the stainless steel cheese vat used during the production of Oaxaca String Cheese contained a gap in the weld thereby providing a niche for the collection of food residue.
The above violations are not meant to be an all-inclusive list of deficiencies in your plant. It is your responsibility to ensure that your facility and all of your products are in compliance with the Act and all applicable regulations. You should take prompt action to correct all of the violations noted in this letter and to establish and implement procedures that will prevent such violations from occurring in the future. Failure to implement lasting corrective action may result in FDA taking regulatory action, such as seizure or injunction, without further notice.
We acknowledge that, beginning on August 26, 2010, you voluntarily closed your facility, placed all of your cheese products on embargo and ultimately destroyed them, and voluntarily recalled all cheese products that had been manufactured at 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. While we acknowledge receiving your responses during the month of September and
October of 2010 to the FDA Form 483 (Inspectional Observations) that was issued to Alejandro Cuautle (President at the time of issuance) on August 18, 2010, we have determined that your written responses are inadequate to address the objectionableconditions in the following ways: Your responses to the FDA Form 483 observations indicate that you have corrected the plumbing and draining systems in your facility and have replaced the flooring and walls in the production area; however, the follow-up inspection conducted October 25 through November 8, 2010 documents that these corrections were not adequate and that CGMP violations continue to exist. FDA has determined that the proper plumbing and drainage system has not been installed in your facility and you have not been able to properly remove sewage and liquid disposable waste from the plant.
In addition to the above violations, we have the following comments:
• During the October 25 through November 8, 2010 inspection, investigators observed a pallet containing approximately (b)(4) 45-lb boxes of whole milk mozzarella curd used to manufacture Oaxaca string cheese that was stored unrefrigerated for at least five hours in a hallway leading to the entrance to the production area. Please be advised that, pursuant to 21 CFR 110.80(a)(5), you must hold raw materials and other ingredients at such temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated.
• During the October 25 through November 8, 2010 inspection, you were unable to provide documentation of employee training regarding CGMPs. Under 21 CFR 110.10(c), food handlers and supervisors should receive appropriate training in proper food handling techniques and food-protection principles and should be informed of the danger of poor personal hygiene and insanitary practices.
• The follow-up inspection also evaluated your firm's compliance with the written procedures (Basic Good Manufacturing Practices and Listeria Sampling Program) provided by your consultant on October 1 and October 25, 2010. The FDA has determined that these plans and written procedures were not followed and implemented by your firm. No environmental sampling or finished product sampling was performed by your firm as per your consultant's written procedures at the time of this inspection in order to monitor your manufacturing activities and the possible contamination of your RTE soft cheese with L. monocytogenes.
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 the above 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 reasons for your delay and state when you will correct any remaining violations. Please include in your response information regarding your implementation of the plans and written procedures that were provided by your consultant.
Your response should be directed to the New Jersey District, FDA, 10 Waterview Blvd., 3rd Floor, Parsippany, New Jersey 07054, Attn: Robert J. Maffei, Compliance Officer. If you have any questions regarding this letter, please contact Mr. Maffei at (973) 331-4906.
Sincerely,
/S/
Diana Amador-Toro
District Director
New Jersey District
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