Inspections, Compliance, Enforcement, and Criminal Investigations

T. Ho Foods, Inc. 7/22/15

  

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

Public Health Service
Food and Drug Administration
 
New Orleans District
404 BNA Drive
Building 200, Suite 500
Nashville, TN 37217-2565
 
Telephone:  615-366-7801
FAX:  615-366-7802

 

July 22, 2015
 
WARNING LETTER NO. 2015-NOL-12
 
 
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Thuc G. Ho and Thoai Ho, Co-Owners
T-Ho Foods
7124 Small Creek Way                                                                            
Powell, Tennessee 37849-4850
 
Dear Messers. Ho:
 
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, located at 7124 Small Creek Way, Powell, Tennessee, on June 1 – 3, 2015. We found 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 123), and the Current Good Manufacturing Practice regulation for foods, 21 CFR 110. In accordance with 21 CFR 123.6(g), failure of a 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 United States Code (USC) 342(a)(4), 21 USC 324(a)(4)]. Accordingly, your seafood products are adulterated, as 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 on FDA’s Internet home page at www.fda.gov.  A Form FDA 483, Inspectional Observations (FDA 483), listing the deficiencies found, was issued to your firm on June 3, 2015.
 
Violations revealed during the inspections include, but are not limited to:
 
Hazard Analysis and Critical Control Point
 
1.    You must fully document in your records all corrective actions taken to comply with 21 CFR 123.7(d). Specifically, you did not document a corrective action was taken when you deviated from your critical limit temperature of (b)(4) for your (b)(4) product at the (b)(4) Step, to control (b)(4) during production on December 1, 2014. The product temperature was recorded as (b)(4) on your (b)(4) Record.
 
2.    You must implement the monitoring procedures and frequencies you have listed in your HACCP plan to comply with 21 CFR 123.6(b). Specifically, your firm did not follow the monitoring frequency of checking the (b)(4) for chips and damages at the (b)(4)” step to control the physical hazard of (b)(4) listed in your HACCP plan for (b)(4)  Your HACCP plan states you will record your findings on the “(b)(4)” However, you do not maintain a “(b)(4)” and equipment is documented as being inspected once a day on the (b)(4) and twice a day on the (b)(4) during an approximate (b)(4) hour production shift.
 
This is a repeat observation from our January 2014 inspection.
 
During the inspection, you reportedly told the investigator you would change the frequency of the monitoring on your HACCP plan to accurately reflect your practices. Please provide an updated version of your HACCP plan. 
 
3.    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 HACCP plan for (b)(4) does not list the food safety hazards of undeclared allergens at the labeling critical control point. Your HACCP plan incorrectly lists “(b)(4)” at the labeling critical control point.
 
This is a repeat observation from our January and September 2014 inspections.
 
4.    You must sign and date your HACCP plan upon modification, as required by 21 CFR 123.6(d). Specifically, your HACCP plan for (b)(4) was not signed and dated after your re-assessment of your seafood manufacturing process in January 2015.  In order to comply with 21 CFR 123.6(d) the HACCP plan must be signed and dated either by the most responsible individual onsite at the processing facility or by a higher level official of the processor. This signature shall signify the HACCP plan has been accepted for implementation by the firm.
 
Good Manufacturing Practices
 
5.    Your firm failed to take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, our investigator discovered evidence of rodent activity in your food processing facility. At least 67 apparent rodent excreta pellets were observed in multiple locations on the first and second floor of your processing plant including areas which stored food ingredients and packaging materials.  Evidence of rodent activity was observed in the following areas on June 1, 2015:
 
  • At least seven apparent rodent excreta pellets (aREPs) on the floor along the southeast wall of the warehouse behind the vending machine for drinks and adjacent to a pallet holding various packaging materials and plastic tubs of powdered meat bases.
  • At least 13 aREPs on and under a pallet covered with a piece of cardboard along the southeast wall of the warehouse which was holding cases of glass jar packaging materials and several paper bags of bread crumbs.
  • At least three aREPs on a pallet and 35 aREPs on the floor adjacent to a pallet holding flour and bread crumbs. The pallet was located adjacent to the lift along the northwest wall of the warehouse.
  • At least five aREPs on the floor in the west corner and at least six aREPs on the floor along the southwest wall of the spice room on the second floor.
  • At least four aREPs on the floor in the storage area adjacent to the northeast entrance to the spice room on the second floor. 
This is a repeat observation from our June 2013 and January 2014 inspections, and was also documented on Warning Letter 2013-NOL-15.
 
6.    Your firm failed to properly store equipment, remove litter and waste, and cut weeds or grass which may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures, as required by 21 CFR 110.20(a)(1). Specifically, a discarded sink basin, numerous pieces of cardboard and tall weeds were observed along the southeast exterior wall of the facility.  Additionally, the dock area along the northeast exterior of the facility was observed to be cluttered with numerous pieces of unused equipment, including but not limited to, buckets, pallets, and a baker’s rack.
 
7.    Your firm failed to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food, food-contact surfaces, and food packaging materials, as required by 21 CFR 110.20(b)(6).  Specifically, on June 1, 2015, the investigator observed several fans with fan guards covered with dust and debris in operation where food was exposed in the production areas. These included the two fans of the cooling unit in the cold room. These fans were observed to be blowing directly onto areas where employees were chopping vegetable ingredients and assembling vegetable spring rolls. Additionally, a box fan on a table and a pedestal fan were observed blowing in the area where barbeque sauce was being manufactured and packaged.
 
A similar observation was discussed with your firm during the January 2014 inspection.
 
8.    Your firm failed to store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination, as required by 21 CFR 110.80(b)(2).  Specifically, a cardboard container with a plastic liner holding bulk ketchup was observed uncovered within the production room from approximately 10:30 a.m. to 3:00 p.m. on June 1, 2015.
 
9.    Your plant is not constructed in such a manner as to prevent drip and condensate from contaminating food and food-packaging materials, as required by 21 CFR 110.20(b)(4). Specifically, water was observed leaking from the exterior freezer wall. Pooled water was observed on the floor adjacent to several pallets holding various food products, including paper bags of bread crumbs, and foil pouches of ketchup in cardboard boxes. Additionally, ice condensation drip was observed adhering to boxes of crinkle cut carrot ingredients and finished package cases of cheese grits, which were stored under the refrigeration unit in the freezer.
 
A similar observation concerning condensate was discussed with your firm during the January 2014 inspection and documented on Warning Letter 2013-NOL-15.
 
10.    Your firm failed to maintain gloves, used in food handling, in an intact, clean, and sanitary condition, as required by 21 CFR 110.10(b)(5). Specifically, on June 1 and 2, 2015, our investigator observed two employees blowing into a pair of their disposable gloves prior to putting them on and returning to work to handle food and food contact surfaces.
 
11.    Your firm failed to properly maintain plant equipment as to be adequately cleanable and properly maintained, as required by 21 CFR 110.40(a). Specifically, a hand held wire whisk with a broken wire loop was observed being used to mix a batch of test barbeque sauce. 21 CFR 110.40(a) requires all plant equipment and utensils shall be designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. The design, construction and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces.
 
This is a repeat observation from our June 2013, January and September 2014 inspections, and documented on Warning Letter 2013-NOL-15.
 
12.    Your firm failed to maintain equipment and utensils in an acceptable condition through appropriate cleaning and sanitizing, as required by 21 CFR 110.80(b)(1). Specifically, the table-top can opener stored on the bottom shelf of a stainless steel table was rusty and coated with debris.  Additionally, the dry mix blender/spice packaging equipment was observed having adhering food particles on the auger/shaft connection and the mixing paddle attachment.
 
13.    Your firm failed to maintain buildings in repair sufficient to prevent food from becoming adulterated, as required by 21 CFR 110.35(a).  Specifically, the floors of the processing and ware washing areas were observed to have peeling paint, cracks, and areas where the surface was eroded.
 
This is a repeat observation from our June 2013, January and September 2014 inspections, and documented on Warning Letter 2013-NOL-15.
 
This letter is not intended to be an all-inclusive list of deficiencies in your plant. It is your responsibility to ensure all of your products comply with the Act, the Fish and Fishery Products regulations (21 CFR 123), Current Good Manufacturing Practice regulations (21 CFR 110), and other applicable regulations. The specific violations noted in this letter and on the FDA 483’s, issued at the close out of the inspections, may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in FDA taking regulatory action without further notice, such as seizure or injunction.
 
You should respond in writing within 15 working days from the date you receive this letter. Your response should include specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned correction will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Your response should be comprehensive and address all violations included in this Warning Letter.
 
Section 743 of the Act (21 USC 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-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. Re-inspection-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 re-inspection fees [21 USC 379j-31(a)(2)(B)]. FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The 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 re-inspection-related costs.
 
Your response should be sent to: Ms. Kimberly Dutzek, Compliance Officer, at the address above. If you have any questions about the content of this letter please contact Ms. Dutzek at (615) 366-7826.
 
Sincerely,
/S/                                                                       
Ruth P. Dixon
District Director
New Orleans District

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