| Public Health Service Food and Drug Administration |
Dallas District |
Department of Health and Human ServicesJanuary 31, 2011
2011·DAL-WL-07
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Leslie Charles "Charlie" Rankin, Co-Owner
Mom's Food Products, Inc.
4117 Garland Drive
Ft. Worth, Texas 76117-1706
Dear Mr. Rankin:
We inspected your seafood processing establishment, located at 4117 Garland Drive, Ft. Worth, Texas, on July 20-29, 2010. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products 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).
Accordingly, your tuna salad sandwiches packed in a modified or reduced oxygen packaging material are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR §123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR §123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plan entitled "HCCP PLAN TUNA FISH SANDWICH" which was collected during the inspection, does not list the food safety hazards of Clostridium botulinum growth and toxin formation, the hazard of undeclared allergens, and the hazard of histamines. We note that in your response to the FDA-483, you indicated that you have made corrections; however, you did not provide a copy of a revised HACCP Plan.
a. During the inspection your firm packaged Mom's Deli Style Tuna Salad Sandwich on Wheat Bread (5 oz.) and Mom's Deli Style Tuna Salad Sandwich on White Bread (5 oz.), in a polypropylene triangle wedge covered by a film with an oxygen transmission rate of (b)(4) cc/100in2 at 22°C. Approximately one half of the film was covered with a peel and stick label, further restricting oxygen permeability. The combination of packaging significantly limits the flow of oxygen and creates conditions that are conducive to Clostridium botulinum growth and toxin formation (i.e., a modified or reduced oxygen package). In your October 7, 2010 response, your firm provided specification for a new film to be used to continue manufacturing of tuna salad sandwiches. The new specification sheet indicates an oxygen permeability of (b)(4) cc/100in2 at 22°C. Based on the new specifications, the packaging continues to inhibit safe oxygen transmission. Clostridium botulinum continues to pose a reasonably likely food safety hazard for the tuna salad sandwiches manufactured by your firm. FDA considers a minimum oxygen transmission rate of 10,000 ccl m2/24 hrs to be oxygen permeable.
Chapter 13 of the Guide lists guidance for controlling C. botulinum growth and toxin formation that can help you choose a method of control most suited to your process.
b. The tuna salad your firm uses to manufacture Mom's Deli Style Tuna Salad Sandwich on Wheat Bread (5 oz.) and Mom's Deli Style Tuna Salad Sandwich on White Bread (5 oz.), includes the ingredients: tuna, eggs, soy, Wheat, and milk. Fish, wheat, soy, eggs, and milk are considered major food allergens. HACCP plans for fishery products that contain these ingredients should list and control the hazard of undeclared allergens. Chapter 19 of the Fish and Fisheries Products Hazards & Controls Guidance (the Guide) contains additional information regarding the control of this hazard.
2. You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, during the inspection, your firm did not take a corrective action to control pathogen growth when your process for tuna sandwiches deviated from your critical limit at the storage temperature critical control point. Specifically, the temperature for Cooler # (b)(4) a cooler used to store bulk tuna salad and, on occasion, finished product tuna salad sandwiches, exceeded your critical limit of (b)(4)°F on May 5, 2010 at 1:03 PM. Your firm could not provide evidence that a corrective action was taken to correct the deviation or its cause and prevent interstate distribution of affected product. Your response did not address this issue.
3. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR §123.11(b). However, during the inspection it was observed that your firm did not monitor safety of water that comes into contact with food or food contact surfaces, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, and the protection of food, and food contact surfaces from adulteration with sufficient frequency to ensure control as evidenced by these insanitary conditions that were not addressed in any of your firm's responses.
• On July 22, 2010, an employee was observed conducting the pre-operational sanitation inspection without first washing her hands after entering the production room. The inspector was observed touching food contact surfaces without gloves. Following the sanitation inspection, some, but not all, food contact surfaces were sprayed with a sanitizer bottle by a sanitation employee. However, the sanitizer within the bottle was found to only contain (b)(4) pm , rather then (b)(4) ppm (b)(4) per the sanitizer's instructions. Further, the inspection failed to include inspection of the hand washing sinks, and there were no records of checking hand sinks since June 24, 2010. Also, there were no records of checking the toilet facilities since June 11,2010.
• On July 20, 2010 two employees working on the cold line swept the floor and emptied the trash during the change out between turkey and swiss sandwiches and tuna salad sandwiches. When they finished cleaning, they washed their hands and changed their gloves, but did not change the plastic arms sleeves that extend down their arms to their wrists. They then proceeded to assemble Mom's Deli Fresh Tuna Salad Sandwiches lot 8/11/10.
• On July 20, 2010 the hand sink in the MAP room was blocked and inaccessible to all employees except those who were working along the backside of the roll stock packaging machine. Mom's Deli Style Tuna Salad Sandwiches lot 08/11/10 and Jumbo Turkey & Swiss lot 8/11/10 were being packaged in the room at the time.
• On July 21, 2010 water was dripping from the drain line of a ceiling cooling unit next to (b)(4) line #(b)(4) in the MAP room. Rolling racks containing empty bread trays on which sandwiches, including tuna salad sandwiches, are held were stored beneath this dripping line. These bread trays are used repeatedly throughout the week without washing, and when they are washed it is done using a power washer in the parking lot outside and without a sanitization step. Also, when this drip was pointed out to a production employee, that employee then obtained a broom that is used to sweep the floor and a rag and dabbed at the drip with the rag on the bristle end of the broom.
• Your firm uses (b)(4) sanitizer on equipment and in dip and utensil buckets during production. On July 20, 2010, while Mom's Deli Fresh Tuna Salad Sandwiches were being assembled (lot 8/11/10), a container was observed on a table next to the cold line that contained food contact utensils (knives, spatulas) soaking in sanitizer that was measured to be (b)(4) ppm (b)(4) instead of (b)(4) ppm.
4. You must maintain adequate sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11 (c).
However your firm has not maintained adequate sanitation monitoring records for 1) checking hand sinks since June 24, 2010; and 2) checking toilet facilities required for the processing of tuna fish sandwich since June 11, 2010.
Your firm receives your raw material tuna salad manufactured and packaged in 30 pound bulk containers under refrigerated conditions. Pathogen growth, including potentially Clostridium botulinum growth and toxin formation, as well as histamine development are reasonably likely hazards that can occur during transit if the tuna is exposed to time and temperature abuse. We acknowledge your firm's response indicating that you have added a critical control point for receiving, however, because you did not provide a copy of the revised plan or fully explain the parameters listed in the revised plan, we are unable to assess its adequacy.
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.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the progress of the specific things you are doing to correct these violations. Please send examples of any documentation showing that corrections have been achieved. If you cannot complete all the requested information before you respond, please explain the reason for your delay and the date that we can expect the requested documentation.
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, the seafood HACCP regulation (21 CFR Part 123) 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 send your reply to the Food and Drug Administration, Attention: Sherrie L. Krolczyk, Compliance Officer, at the above letterhead address. If you have questions regarding any issues in this letter, please contact Sherrie L. Krolczyk at (214)253-5312.
Sincerely,
/s/
Reynado R. Rodriguez, Jr.
Dallas District Director
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