| || |
Department of Health and Human Services
|Food and Drug Administration|
555 Winderley Place, Suite 200
Maitland, Florida 32751
VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
July 8, 2015
Mr. Christian Rivas
Oasis Brands, Inc.
13439 NW 19th Lane
Miami, FL 33182
Dear Mr. Rivas:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your cheese manufacturing facility Oasis Brands Inc., located at, 13439 NW 19th Lane, Miami, FL 33182 between August 1st through the 22nd, 2014 and again between October 7 and December 16, 2014. Based on findings from our inspection, cheese products manufactured at your facility 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 have been prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. Based on analytical samples, your Lacteos Santa Martha Quesito Casero Fresh Curd cheese product manufactured at your facility is also adulterated within the meaning of section 402(a)(1) of the Act [21 U.S.C. § 342(a)(1)] in that it bears or contains a poisonous and deleterious substance, Listeria monocytogenes (L. monocytogenes), which may render it injurious to health.
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. Listeriosis is an atypical food borne 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. Listeriosis in pregnant women is typically a mild “flu-like” illness, but can result in fetal death, premature labor, or neonatal infection.
During our latter inspection, you committed to shut down operations and discontinue processing and repackaging of cheese products. You told our investigator that you would notify the Florida Department of Agriculture and Consumer Services prior to resuming processing or packaging. Your decision to shut down processing and repackaging came after a series of events beginning with a finding of a strain of L. monocytogenes in product manufactured by your firm. We appreciate that you discontinued processing and repacking. If you have resumed, or plan to resume repacking, we request that you provide us with documentation demonstrating that you are adequately controlling the hazard of L. monocytogenes at your facility. You may wish to include documentation relative to structural changes you have made in your facility, your sanitary standard operating procedures, verification procedures and a schedule for environmental and product testing in conjunction with monitoring records demonstrating that you have implemented those procedures.
The Virginia Department of Agriculture and Consumer Services isolated L. monocytogenes from a sample of your Lacteos Santa Martha Quesito Casero Fresh Curd on July 16, 2014. Accordingly, your Lacteos Santa Martha Quesito Casero Fresh Curd product is adulterated within the meaning of section 402(a)(1) of the Act [21 U.S.C. § 342(a)(1)] in that it bears or contains any poisonous or deleterious substance which may render it injurious to health.
In response to that finding, FDA conducted an inspection between August 1 – 22, 2014.
During that inspection, FDA investigators collected environmental samples (FDA samples # 844400 and 867054) consisting of eighty-four (84) swabs taken from various food contact and non-food contact surfaces throughout your facility. Four (4) of the environmental swabs tested positive for L. monocytogenes as follows: Sub 59 from an in-process tray located between racks #2 and #3, Sub 2 taken from a “dirty” tray in the “Cheese Manufacturing Room”, Sub 35 from the floor in front of the processing table in the “Cheese Manufacturing Room,” and Sub 37 from the space between the floor and the grease trap metal door on the floor in the “Cheese Manufacturing Room”. Based on pulsed field gel electrophoresis (PFGE) analysis, the four isolates were indistinguishable to each other and to the isolate recovered from your cheese product collected by the Virginia Department of Agriculture and Consumer Services. These results indicate that your facility has a L. monocytogenes harborage problem.
During the inspection our investigators also documented the following violation of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110):
You failed to clean and sanitize equipment in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 110.35(a). Specifically, our investigator found that you do not sanitize, but rather use only soap and water to clean the blue cart bin used to store your cut hard cheese, the knives used for cutting cheese, and the trays used to hold cheese curd. This is inadequate to control L. monocytogenes in the food processing environment. A sample of the “hard” cheese that was cut on the week of September 22, 2014 and was stored in one of the two blue cart bins was collected by the FDA on October 10, 2014 (FDA sample #867058) and was found to be positive for L. monocytogenes. During our inspection, you informed our investigator that this cheese had been cut with the intention to use it in the manufacture of cheese curd.
Further, Listeria spp. was isolated by your contract laboratory from product samples taken from your facility after you had cleaned and had taken corrective action. These findings demonstrate that your cleaning procedures are inadequate. FDA’s Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods; Draft Guidance recommends that standard sanitary operating procedures for cleaning equipment include:
• Removal of heavy soil or debris from equipment, if needed;
• Pre-rinsing the equipment;
• Foaming and scrubbing the equipment with an effective cleaner;
• Rinsing the equipment after treating it with the cleaner;
• Sanitizing equipment, and
• Visual inspection of food-contact surfaces for residues of cleaning agents or sanitizing agents.
You failed to report a reportable food to the Reportable Food Registry within twenty-four hours of determining that an article of food is a reportable food for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals, as required by section 417(d)(1) of the Act [21 U.S.C. § 350f(d)(1)]. Specifically:
• On August 25, 2014, you submitted a sample of your Lacteos Santa Martha Cuajada en Hoja (Fresh Curd) product, Best By “10/18/14” to your contract laboratory for analysis. On September 3, 2014, you were verbally notified by your contract laboratory that such sample was found to be positive for Listeria spp. Therefore, you determined that your Lacteos Santa Martha Cuajada en Hoja (Fresh Curd) product, Best By “10/18/14” was a reportable food on or about September 3, 2014, but you did not submit a report to the Reportable Food Registry about this product until October 9, 2014.
• On September 22, 2014, you submitted a sample of your Lacteos Santa Martha Cuajada en Hoja (Fresh Curd) product, Best By “11/15/14” to your contract laboratory for analysis. On September 24, 2014, you were verbally notified that such sample was found to be positive for Listeria spp. Therefore, you determined that your Lacteos Santa Martha Cuajada en Hoja (Fresh Curd) product, Best By “11/15/14” was a reportable food on or about September 24, 2014, but you did not submit a report to the Reportable Food Registry about this product.
The Reportable Food Registry was established by section 1005 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-085) to provide a reliable mechanism to track patterns of adulteration in food in order to support efforts by FDA to target limited inspection resources to protect the public health. It requires a responsible party to file a report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. Such foods are “Reportable Foods.” The responsible party is the person who submits the registration under section 415(a) of the Act [21 U.S.C. § 350f(d)] for a food facility that is required to register under section 415(a), at which such article of food is manufactured, processed, packed, or held. Failure to submit a required report about a reportable food is a prohibited act under section 301(mm) of the Act [21 U.S.C. § 331(mm)].
This letter may not list all the violations that may exist at your facility or in connection with your products or their labeling. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. You are responsible for ensuring that your processing plant operates in compliance with the Act and applicable FDA regulations, including the Current Good Manufacturing Practice regulation (21 CFR Part 110).
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.
Additionally, 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 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 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 U.S. Food and Drug Administration, Attention: Carla A. Norris, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions regarding any issues in this letter, please contact Ms. Norris by telephone at (407) 475-4730.
Susan M. Turcovski
Director, Florida District