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U.S. Department of Health and Human Services

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Enforcement Actions

Chung's Products, LP 30-Oct-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Dallas District
4040 North Control Expressway
Dallas, Texas 75204-3128


October 30, 2007

2008-DAL-WL-01

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Mr. Vreij Kolandjian
Chief Executive Officer
Chung's Products, LP
dba Chung's Gourmet Foods
3907 Dennis Street
Houston, Texas 77004

Dear Mr. Kolandjian:

We inspected your facility, located at 3907 Dennis Street, Houston, Texas, on May 23-24, 29-31, 2007, and June 19, 22, and 29, 2007. 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, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Parts 123 & 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 shrimp, and seafood egg rolls 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 11 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 for fully cooked, modified atmospheric packed (MAP) shrimp and seafood egg rolls does not list the food safety hazard Clostridium botulinum growth and toxin formation.

Specifically, your firm packages shrimp and seafood egg rolls in a packaging material that has an oxygen transmission rate at [redacted]. This rate is consistent with an oxygen impermeable material, and thus this material creates an atmosphere conducive to Clostridium botulinum growth and toxin formation (i.e., a modified or reduced oxygen package). Consequently, Clostridium botulinum is a reasonably likely food safety hazard for these modified or reduced oxygen packaged egg roll products. Your firm supplies an information sheet in each case of egg roll products shipped to customers who will thaw and hold the egg rolls in the refrigerated section of their deli case. The insert reads either:

o "Attention Deli/Meat Clerk: Please date product 21 days from today's date if you are placing product in the FRESH deli/meat section. Product should be maintained @ 45 degrees or below"

or

o "Attention Deli/Meat Clerk: Please date product 28 days from today's date if you are placing product in the FRESH deli/meat section. Product should be maintained @ 45 degrees or below"

In addition, the labeling on your modified or reduced atmosphere packaged egg roll products is as follows:

o "Previously Handled Frozen For Your Protection. Refreeze Or Keep Refrigerated"

o "SHIPPED, STORED AND HANDLED FROZEN FOR YOUR PROTECTION, KEEP REFRIGERATED OR FREEZE"

Maintaining the products in a frozen state, as you do while the products are at your facility is an adequate control for Clostridium botulinum, however, the labeling and inserts that you use allowing-the product to be distributed in a refrigerated state prevent this from being an effective and/or adequate secondary barrier.

Because your firm is creating the hazard of Clostridium botulinum by using an oxygen impermeable packaging material, you are responsible for control of the hazard of Clostridium botulinum and labeling is an inadequate control. FDA recommends the use of a secondary barrier in addition to refrigeration for modified atmosphere packaged products intended to be kept refrigerated, because modified atmospheric packaging extends the shelf life and there is a high likelihood that these products could be mishandled at some point during refrigerated handling and/or by the end user.

We acknowledge that your firm provided the results of a challenge study conducted by the [redacted] in support of your position that these products do not pose a hazard for Clostridium botulinum and/or would become overtly spoiled before toxin production when held under refrigerated conditions. However, as we indicated in previous communications dated August 7, 2006 and February 7, 2007, we had concerns and questions regarding the study and consequently we found the results to be inconclusive.

2. You must verify that your HACCP plan is adequate to control the food safety hazards that are reasonably likely to occur and verify that the plan is being effectively implemented, to comply with 21 CFR § 123.8(a). However, your firm did not verify the adequacy of the critical limit of [redacted] to be maintained for a minimum of [redacted] for egg rolls at the "Frying" critical control point to control pathogens. Your HACCP plan lists that you will monitor internal product temperature at [redacted] to be maintained for a minimum of [redacted] after frying to control pathogens. However, End-Point Internal Product Temperature (EPIPT), i.e., a measurement of the temperature of the product as it exits the heat process, is suitable only if you have conducted a scientific study to validate that the EPIPT selected will provide an appropriate reduction in the numbers of the target pathogen (e.g., usually a 6D log reduction) in the slowest heating unit/portion of product under the worst set of heating conditions. Monitoring product internal temperatures is not ordinarily recommended because of the variability from unit to unit. Process establishment (i.e., validation) should include conducting: (1) a temperature distribution study within the heating system to identify any cold spots; and (2) a heat penetration study that accounts for the slowest heating product under the worse case heating conditions, including identifying other critical factors of processing and/or packaging that affect the rate of product heating. Moreover, although you had a study conducted by the [redacted] you need to stay with the scheduled process provided for the study to constitute adequate validation. Any changes in the times and/or temperatures would need to be verified by the process authority.

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, 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:

Safety of water

• Water that is [redacted] or greater, in a [redacted] gallon container, is supplied to the employees for the hand dip water for the rolling employees. The employees use the water to help roll each of the egg rolls and water is added to each of the skins by hand just prior to the addition of the egg roll filling. There is an accumulation of filling material in each of the employees dip buckets, the water is exchanged at the discretion of the rolling employee, the old water is dumped into a separate waste watertub, and new water is dipped out of the [redacted] gallon container with the employees dip bucket. This process deposits filling material that has come into contact with the employees hands during the rolling process and there is no washing, rinsing and sanitizing of any of the dip buckets or the [redacted] gallon container during the production process. Rinsing is only performed at each break in the operation. There is the potential for Staphylococcus aureus to grow and form toxin in the warm water of the dip buckets and the [redacted] gallon water container.

• An employee was observed rinsing his hands in the [redacted] gallon container of water used to supply the water for the rolling of the firm's egg roll products. The water is not intended for the rinsing or washing of employee hands.

• Liquid from the vegetable filling material was observed leaking from the tub that contained the filling dripping directly into a grey bucket of wash down water stored under the employees work area. The water in the grey bucket was later used to rinse the employees work area during a break in production.

Condition and cleanliness of food contact surfaces

Cleaning and sanitation of the facility is conducted only in the evening and next morning before production begins each day. The firm does not sanitize any of the food work surfaces during the production of the shrimp, seafood and vegetable egg rolls. During employee breaks, the rolling room is rinsed with potable water and the floor is swept to remove the excess filling that has accumulated on the floor.

• The room temperature is between [redacted] and [redacted] during production. The dip buckets and the one gallon container of water used to rinse the employee work area are never washed, rinsed, and sanitized during the hours of production. There is the potential for the growth of Staphylococcus aureus on the employee work surfaces.

Prevention of cross contamination from insanitary objects

• Two employees that dispense the egg roll filling material to the rolling room employees were observed not washing,, rinsing and sanitizing their hands / gloves after coming into contact with insanitary objects. Both employees were observed handling the floor squeegee, and then moving bins of egg roll filling.

• One employee was observed, rinsing his hands in the water used for the rolling of the egg rolls and then picked up a squeegee to clean the floor. The employee did not properly wash, rinse and sanitize his hands at the hand sink in the rolling room.

• The same employee was then observed moving filling product from one employee to another by hand. He would remove the product with his hands and transfer it to another employee's work bin. The employee did not wash rinse and sanitize his hands prior to performing the product transfer.

Protection of food, and food contact surfaces from adulteration

• Condensate was observed dripping from an air-conditioning unit that is directly over the final product conveyor belt where shrimp egg rolls were being processed. The condensate was dripping from the condensate pan and the copper line that enters the unit and the unit is located over the belt that picks up the egg roll product as they exit the "chili room". The conveyor moves the egg rolls to the spiral freezer on the other side of the building. There is the potential for the egg rolls to become adulterated with the condensate water from the air-conditioning unit.

• Condensate was observed to be dripping from the 2nd and 3rd air-conditioning unit (from the vegetable room) located in the rolling room. Shrimp egg roll filling was observed being stored and staged under these units. Condensate was observed dripping into the shrimp egg roll filling prior to being distributed to the rolling room employees for the production of shrimp egg rolls.

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 including the completion of any studies that will eliminate or prevent the food safety hazards discussed above. 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: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have questions regarding any issues in this letter, please contact Carolyn A. Pinney at (214)253-5220.

Sincerely,

/S/

John R. Gridley
Acting Dallas District Director

JRG/cap

cc:
Mr. Charlie A. Kujawa
Vice President of Operations
Chung's Products, LP
dba Chung's Gourmet Foods
3907 Dennis Street
Houston, Texas 77004

Mr. Gregory S. Birdseu
Director of Quality Assurance
Chung's Products, LP
dba Chung's Gourmet Foods
3907 Dennis Street
Houston, Texas 77004

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Warning Letter Response

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