• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Lee K of NY Inc. 10/2/13

  

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

Public Health Service
Food and Drug Administration
 
New York District 
158-15 Liberty Avenue
Jamaica, NY 11433                                       

 

October 2, 2013
 
 
WARNING LETTER NYK-2014-2
 
VIA USPS PRIORITY MAIL
 
Soon Deok Kwon, Owner
LEE K OF NY, INC.
3119 Higgins Street
Flushing, New York 11354                                                                                       
 
Dear Soon Doek Kwon:
 
We inspected your seafood processing facility, located at 3119 Higgins Street, Flushing, New York on April 17, 18, and 22, 2013. 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 grilled mackerel, stewed mackerel, fried whole flounder, stewed ½ dry pollock, spicy fried dried pollock, and salted squid 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 that 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 plans for grilled mackerel and stewed mackerel do not list the food safety hazard of scombrotoxin (histamine) formation. 
 
Once your firm has identified scombrotoxin (histamine) formation as a hazard that is reasonably likely to occur you should include critical control points for the unrefrigerated processing steps, including the unrefrigerated defrosting/thawing step, and the refrigerated storage step for controlling the food safety hazard of scombrotoxin (histamine) formation.
 
2)    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 Part 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 fried whole flounder does not  list the critical control point of refrigerated storage (after salting) for controlling the food safety hazard of pathogen growth and toxin formation, specifically Staphylococcus aureus toxin formation.
 
3)    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 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 plans for grilled mackerel, stewed mackerel, fried whole flounder, stewed ½ dry pollock, and spicy fried dried pollock list a critical limit, (b)(4),” at the “(b)(4)” critical control point that is not adequate to control pathogens because there is  no corresponding critical limit for time. FDA recommends a minimum cooking time of 17 minutes to sufficiently control Listeria monocytogenes at product internal temperature of 145°F. Please refer to Table A-3 of the Fish and Fishery Hazards and Controls Guidance for more time and temperature options.
 
4)    You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plans for grilled mackerel, stewed mackerel, fried whole flounder, stewed ½ dry pollock, and spicy fried dried pollock list a monitoring procedure/frequency at the “(b)(4)” critical control point that is not adequate to control pathogens. FDA recommends  that you visually monitor the length of the cooling cycle, along with the internal temperature of the product, using a clock and a temperature-indicating device (e.g., your digital stem thermometer) at frequency of at least every 2 hours. In addition, your firm’s HACCP plans for grilled mackerel, stewed mackerel, fried whole flounder, stewed ½ dry pollock and spicy fried dried pollock list a monitoring procedure/frequency at the “Labeling” critical control point that is not adequate to control allergens. FDA recommends you check the labels on finished product packages for comparison with the product formula (recipe) by visual examination of the finished product labels and product formula at a frequency of a representative number of packages from each lot of finished product.
 
5)    You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not follow the monitoring procedures of monitoring the “(b)(4)” using “… a (b)(4)” at the “(b)(4)” critical control point to control pathogens as listed in your HACCP plan for fried whole flounder. Specifically, on April 18, 2013, our investigator observed your firm's cook step for whole flounder, and no temperature was taken during the cooking, nor was a thermometer available for the employee cooking the fish.
 
6)    You must implement the record keeping system that you listed in your HACCP plan to comply with 21 CFR 123.6(b). However, your firm did not record monitoring observations at the “(b)(4)” and “(b)(4)” critical control points to control pathogens listed in your HACCP plans for grilled mackerel, stewed mackerel, fried whole flounder, stewed ½ dry pollock, and spicy fried dried pollock. In addition, your firm did not record monitoring observations at the “(b)(4)” critical control point to control allergens listed in your HACCP plans for grilled mackerel, stewed mackerel, fried whole flounder, stewed ½ dry pollock, and spicy fried dried pollock. Specifically, you did not have monitoring records for production other than  for product produced on 2/15/13. When asked, you indicated that you were unaware that you were required to fill out the forms listed in your HACCP plan for every production of the associated fish.
 
7)    Because you chose to include corrective actions in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for grilled mackerel, stewed mackerel, fried whole flounder, stewed ½ dry pollock, and spicy fried dried pollock at the “(b)(4),”, “(b)(4)” and “(b)(4)” critical control points are not appropriate to control pathogens because they do not correct the cause of the deviation and do not ensure that adulterated products do not enter into commerce. 
 
o   For batch cooking corrective actions, FDA recommends that firms recook the product, destroy the product, or divert the product to a non-food use to prevent distribution of potentially adulterated product. Alternatively, FDA recommends that firms chill and hold the product for an evaluation of the adequacy of the cooking process. However, if the product has not received an adequate process, it should be destroyed, diverted to a non-food use, or recooked. Additionally, we recommend   that firms adjust the steam supply to increase the processing temperature, if appropriate, or take other actions as necessary, to correct the cause of the deviation.  
 
o   For cooling corrective actions, FDA recommends that firms recook the product (after giving consideration to the fact that additional hazards may have been introduced, such as Staphyloccus aureus toxin that may be present and may not be inactivated  by heat), destroy the product, or divert the product to a non-food use to prevent distribution of potentially adulterated product. Additionally FDA recommends making repairs or adjustments to the malfunctioning cooler to correct the cause of any deviations associated with storage temperatures.
 
o   For labeling corrective actions, FDA recommends that firms segregate and relabel improperly labeled product and modify the label procedures, as appropriate.
 
 
8)    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 condition and cleanliness of food contact surfaces, prevention of cross contamination from insanitary objects, maintenance of hand washing and hand sanitizing facilities, protection of food, food packaging material, and food contact surfaces from adulteration, and exclusion of pests with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
 
a.    Condition and Cleanliness of Food Contact Surfaces
a.    An employee was observed using scissors to cut frozen half dried pollock and then returned them to a container with clean utensils without washing and/or sanitizing the scissors;
b.    On April 18, 2013, several utensils including knives, tongs and ladles were noted stored in unclean metal containers with food debris adhering to the utensils and along the bottom of the containers;
b.    Prevention of Cross Contamination from Insanitary Objects
a.    An employee was observed placing an ungloved and unwashed hand into a plastic container and then used the container to pack ready-to-eat salted squid;
b.    On April 18, 2013, an employee was observed handling insanitary objects and then returned to cutting ready-to-eat squid without washing his hand or changing his gloves;
c.    On April 18, 2013, an employee was observed leaving a workstation, handling insanitary objects then returning to work hand packing ready-to-eat prepared foods without washing her hands or changing her gloves;
c.    Maintenance of Hand Washing and Hand Sanitizing Facilities
a.    On April 17, 2013, our investigator observed that the hand washing sink in the cook area did not have any hot water;
d.    Protection of Food, Food Packaging, Material, and Food Contact Surfaces from Adulteration
a.    Plastic wrap used to overwrap ready-to-eat food trays was observed stored on dirty, degrading corrugated cardboard boxes in the firm’s walk-in cooler; and
e.    Exclusion of Pests
a.    On April 18, 2013, our investigator observed one live mouse in the corner of your walk-in cooler and two deceased mice, nesting material, and rodent excreta pellets in your facility.
 
9)    You must maintain sanitation control records that, at a minimum, document monitoring and corrections to comply with 21 CFR 123.11(c). However your firm did not maintain sanitation monitoring records for the 8 keys of sanitation.
 
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 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 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: Lillian C. Aveta, 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 Ms. Aveta at 718-662-5576 or E-mail at lillian.aveta@fda.hhs.gov.
 
 
Sincerely,
/S/ 
Ronald M. Pace
District Director
New York District
  
cc:       
Kyung H. Kim, Office Manager
LEE K OF NY INC.
3119 Higgins Street
Flushing, New York 11354
 
Timothy Hansen
Director, Seafood Safety Inspection Program
USDC, NOM, NMFS
1315 East-West Highway
Silver Spring, MD 20910