Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, NY 11433
May 28, 2015
WARNING LETTER NYK-2015-34
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Mr. George Chuang, President
Foo Yuan Food Products Co., Inc.
2301 Borden Avenue
Long Island City, NY 11101
Dear Mr. Chuang:
We inspected your seafood processing facility, located at 2301 Borden Avenue, Long Island City, New York on October 14, 15 and 20, 2014. 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). 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 various fish ball and fish cake products are adulterated, in that they havebeen prepared, packed, or held under insanitary conditions whereby theymay 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.
We acknowledge receipt of your letter dated November 3, 2014, which provides a response to FDA’s inspectional observations. We address the adequacy of this response below, in relation to each of the applicable violations if applicable. Your significant violations were as follows:
1. You must conduct 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 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However,
- Your firm’s HACCP plan for “Fish balls” does not list a critical control point for cooking to control the food safety hazard of pathogen growth and toxin formation. Once your firm has included the cooking critical control point, FDA recommends that your HACCP plan include critical limits associated with the cooking process established by a scientific study that will ensure a minimum 6 log reduction of Listeria monocytogenes in all cooked units.
- Your firm’s HACCP plan for “Fried Fish Balls” does not list a critical control point for the overnight refrigerated storage after cooling and before packaging for controlling the food safety hazard of pathogen growth and toxin formation. Once your firm has included the storage critical control point, FDA recommends your HACCP plan include a critical limit that ensures the product is held at a cooler ambient air temperature of 40°F (4.4°C) or below with continuous monitoring of the ambient air temperature of the cooler.
- Your firm’s HACCP plans for “Fish balls” and “Fried Fish Balls” do list a critical control point for refrigerated storage of the refrigerated finished products. Please be advised that because your refrigerated products are vacuum packaged, FDA also recommends that the finished product be held at temperatures of 38 F or below if no secondary barrier is in place.
2. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6 (c) (3). A critical limit is defined in 21 CFR Part 123.3 (c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However,
- Your firm’s HACCP plan “Fried Fish Balls” lists a critical limit of “Clostridium botulinum B spores are destroyed if cooked at (b)(4) for (b)(4)” at the “Cooking” critical control point that is not adequate to control pathogen growth and toxin formation. FDA recommends that your HACCP plan includes critical limits at the cooking critical control point sufficient to control is Listeria monocytogenes. Consequently, your firm needs to ensure through a scientific study that each fish ball receives an adequate cook that results with a minimum 6 log reduction of Listeria monocytogenes in each cooked unit.
- Your firm’s HACCP plans for “Fish Balls” and “Fried Fish Balls” list a critical limit of “Packages are labeled cook at 207°F for five minutes” at the “Packaging & Labeling” critical control point that is not adequate to control Clostridium botulinum toxin formation. Relying on consumers to conduct a cook adequate to control the food safety hazard of Clostridium botulinum toxin formation that is reasonably likely to occur throughout distribution of your refrigerated reduced oxygen packaged finished products is not appropriate. For refrigerated vacuum packaged products, FDA recommends either the use of time temperature indicators on each consumer package (see discussion below regarding the use of time temperature indicators) OR formulating the products so that they achieve a water activity of 0.97 or less; a pH of 5 or less; a water phase salt of 5%or more; or a combination of those factors that provides an equivalent safety assurance. If your firm chooses to use TTIs, the operating parameters of the TTIs should be adequate to control C. botulinum and your HACCP program should also include critical control points specific to the TTI which assure that the TTIs are functional, activated, affixed to every package, and address any limitations of the TTIs such as temperature sensitivities and shelf life.
3. Because you chose to include corrective actions in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7 (b). However, your corrective action plans for “Fish Balls” and “Fried Fish Balls” at the following critical control points are not appropriate. Specifically,
- At the “Packaging & Labeling” critical control point, your HACCP plans list a corrective action of “If not labeled, put a label on packaging.” In addition, FDA recommends that you modify the labeling procedures or the labels, as needed, to correct the cause of the deviation, in addition to segregating and relabeling any improperly labeled product.
- At the “Cooking” critical control point, your HACCP plan for “Fried Fish Balls” lists a corrective action of “If not, recook lot until the (b)(4) is reached for (b)(4)”. In addition, FDA recommends that you make the appropriate adjustments to the cooking process, to correct the cause of the deviation, in addition to recooking the product.
4. You must maintain 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 did not maintain sanitation monitoring records for the safety of the water that comes into contact with food or food contact surfaces or is used in the manufacture of ice; the prevention of cross-contamination from insanitary object to food, food packaging material, and other food contact surfaces; the protection of food, food packaging material and food contact surfaces from adulteration with chemical, physical and biological contaminates; and, the proper labeling, storage and use of toxic compounds, required for the processing of your fish balls and fried fish balls from October 2013 through October 2014.
In your response, dated November 3, 2014, you provided a sanitation log entitled “SANITATION AUDIT FORM” that only provides for 7 of the 8 key areas for sanitation monitoring. The sanitation log does not provide for the monitoring of exclusion of pests from the food plant. We recommend you revise this sanitation log to provide for the monitoring of exclusion of pests.
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 specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, 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 reason for your delay and state when you will correct any remaining violations.
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.
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 re-inspection 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 re-inspection 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 April 2013 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.
Your written response should be sent to: LCDR Frank Verni, Compliance Officer, New York District Office, Food and Drug Administration, 158-15 Liberty Ave., Jamaica, NY 11433. If you have any questions about the content of this letter please contact LCDR Verni at 718-662-5702 or via e-mail at email@example.com.
Ronald M. Pace
New York District