Inspections, Compliance, Enforcement, and Criminal Investigations
VAN Oriental Food, Inc. 30-Oct-07
Department of Health and Human Services
Public Health Service
October 30, 2007
RETURN RECEIPT REQUESTED
Mr. Van Nguyen, Co-Owner
VAN Oriental Food, Inc.
4828 Reading Street
Dallas, Texas 75247
Dear Mr. Nguyen:
We inspected your shrimp and vegetable egg roll manufacturing facility, located at 4828 Reading Street, Dallas, Texas, on August 21, 22, 24, and 28, 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 egg rolls 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 Part 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 "NOT FULLY COOKED NON-MEAT EGG ROLLS / DUMPLINGS," reduced oxygen packed(ROP) shrimp egg rolls does not list the food safety hazard of Clostridium botulinum growth and toxin formation.
Specifically, your firm continues to package shrimp egg rolls in a packaging material that is oxygen impermeable and thus creates an atmosphere conducive to Clostridium botulinum growth and toxin formation. Consequently, Clostridium botulinum is a reasonably likely food safety hazard for these modified or reduced oxygen packaged egg roll products. Moreover, your product labels instruct the consumer to refreeze or keep refrigerated and you send a price list to your new customers that specifies the shelf life for these products frozen, at 25'F, is 12 months; and refrigerated (ROP), at 37'F, is 21 days.
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 price list for new customers that you use allowing the product to be distributed and/or stored in a refrigerated state prevent this from being an effective and/or adequate secondary barrier.
FDA recommends the use of a secondary barrier in addition to refrigeration for modified or reduced atmosphere packaged products intended to be kept refrigerated because modified or reduced 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 receipt of your letter of response to the FDA 483, Inspectional Observations, dated September 12, 2007. In your response, you state that you conducted a hazard analysis (i.e., a study) that concluded that the presence of oxygen in the package acts as an adequate barrier, making the hazard of Clostridium botulinum not reasonably likely to occur under refrigerated conditions. This study does not provide enough data and information to demonstrate that its results are valid. Because the results are inconclusive with regard to control of the hazard Clostridium botulinum growth and toxin formation, your response is inadequate.
2. You must conduct or have conducted for you a hazard analysis 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 critical control points; to comply with 21CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR Part 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and the food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm's HACCP plan for shrimp egg rolls does not list the critical control point of "cooking" for controlling the food safety hazard of pathogen growth, specifically, Listeria monocytogenes.
In your letter of response dated September 12, 2007, you state that you conducted a lethality study for Listeria monocytogenes. At the conclusion of this study, you determined that pathogen growth (i.e., Listeria monocytogenes) is not reasonably likely to occur. However, the study does not provide enough information in order to demonstrate that its results are valid. Because the results are inconclusive with regard to control of the hazard of pathogen growth, specifically growth of Listeria monocytogenes, your response is inadequate. In addition, your plan indicates that these products are " . . . Not Fully Cooked . . ." and thus you conclude that they are not ready to eat. FDA considers products as ready to eat if they "appear" to be ready to eat. Moreover, you state in your response that the temperatures in your study exceeded the FDA requirements for Listeria monocytogenes inactivation. A cook of this type would render the products ready to eat.
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: 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.
John R. Gridley
Acting Dallas District Director
Mr. Apollo Nguyen
Vice President of Operations
VAN Oriental Food, Inc.
4828 Reading Street
Dallas, Texas 75247