Inspections, Compliance, Enforcement, and Criminal Investigations

House of Webster, Inc 5/3/16

  

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

Public Health Service
Food and Drug Administration
 Dallas District Office
4040 North Central Expressway
Suite 300
Dallas, Texas 75204-3128

 

May 3, 2016
 
2016-DAL-WL-21
 
WARNING LETTER
 
UPS OVERNIGHT
 
John Griffin, President
House of Webster, Inc.
111 South Cherokee Street
Muskogee, Oklahoma 74403
 
Dear Mr. Griffin:
 
On December 9 – 14, 2015, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 1013 North 2nd Street, Rogers, Arkansas, where you manufacture acidified foods. The inspection revealed serious violations of the regulations for acidified foods, Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR Part 108), Part 114, Acidified Foods, (21 CFR 114), as well as violations of the current Good Manufacturing Practices for Human Food, Part 110 (21 CFR 110). Accordingly, we have determined that your acidified food products are 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)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and the Acidified Foods regulations through links on FDA’s homepage at http://www.fda.gov.
 
As an acidified food processor, you are required to comply with the Act and the federal regulations relating to processing of acidified foods and current good manufacturing practices. These regulations are described in 21 CFR 108, Emergency Permit Control, 21 CFR 110, GMPs for Human Food, and 21 CFR 114, Acidified Foods. The Emergency Permit Control Regulation was issued, in part, pursuant to Section 404 of the Act (21 U.S.C. § 344). A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR 114.
 
During our inspection, we observed the following significant violations:
 
1.    Your firm failed to process each acidified food in conformity with at least the scheduled process, as required by 21 CFR 108.25(c)(3)(i). Specifically,
 
a.    Your firm had a scheduled process for “Black Bean and Corn Salsa” that was filed with the FDA on (b)(4), that listed a maximum equilibrium pH of (b)(4), and a hot fill and hold process of (b)(4)°F fill temperature with a (b)(4) hold. (SID #(b)(4)). However, the (b)(4) records which document the temperatures in the kettles used to heat the product before filling and your “Operational Filler Report” which documents the product fill temperature, indicate that you failed to manufacture your “Black Bean and Corn Salsa” according to the scheduled process. On March 17, 2015, you manufactured (b)(4) batches of “Black Bean and Corn Salsa” for which your records indicate that you processed each of the batches to temperatures below the required (b)(4)°F. Also, the recorded fill temperatures for these batches range from (b)(4)°F, below the scheduled fill temperature of (b)(4)°F. Additionally, there are no records that indicate the hold time after filling for any of these batches.
 
b.     Your firm has a scheduled process for “Black Bean and Corn Salsa” that was filed with the FDA on (b)(4), that lists a maximum equilibrium pH of (b)(4), a (b)(4)°F in kettle processing temperature for (b)(4), then hot-fill at or above (b)(4)°F and hold for a minimum of (b)(4)(SID #(b)(4)). However, the (b)(4) records which document the temperatures in the kettles used to deliver your scheduled thermal process and your “Operational Filler Report” which documents the product fill temperature, indicate that, you failed to manufacture “Black Bean and Corn Salsa” according to the scheduled process. On September 15, 2015, you manufactured (b)(4) batches of “Black Bean and Corn Salsa.” Your records indicate the in kettle processing temperature was below the required (b)(4)°F. Also, the recorded fill temperature for batch #(b)(4) was (b)(4)°F, below the scheduled fill temperature of (b)(4)°F. Additionally, there are no records that indicate the hold time after filling for any of these batches.
 
In your response, dated December 31, 2015, you state that you replaced your (b)(4) recorders, which monitor temperatures in your “(b)(4) Kettles”, because during a third party on-site calibration procedure, the (b)(4) recorders were found to be out of tolerance with the manufacturer’s specifications. Based on the results of the calibration procedure, you believe the (b)(4) recorders were recording the temperature (b)(4)°F below the actual temperature in the kettles. You further stated that your “Black Bean and Corn Salsa” processing time and temperature will be documented while the product is in your “(b)(4) Kettles” and added that if the (b)(4) recorders are not functioning properly your employees will document the process on your new “Process Tracking Sheet”. We cannot evaluate the entirety of your response because of lack of supporting documentation. If you have implemented these corrections, please submit documentation demonstrating such with your response to this letter.
  
You further explained that you have trained your cook room employees that the minimum fill temperature for hot-fill and hold products is (b)(4)°F. Please note that the process on file with the FDA for your “Black Bean and Corn Salsa” (SID: (b)(4)) lists a minimum fill temperature of (b)(4)°F, and includes a hold time of (b)(4). Your response indicates that your correction to this deviation is inadequate, as you are not adhering to your filed process fill temperature, and you have not addressed the lack of monitoring of hold time after filling.
 
Your response also included documentation showing that you requested a review from your Process Authority of time and temperature charts for your acidified products, which appeared to have process deviations. According to the email correspondence dated December 22, 2015 which you provided in your response, your Process Authority found that some of the product batches did not attain the required least sterilizing value (LSV) and thus would be considered under processed, even considering the (b)(4)°F temperature correction, mentioned above. It is also noted that your Process Authority advised that the product batches, which may have been under processed, while having a low risk of supporting spoilage organisms over time, should not cause serious health effects if consumed. As a manufacturer of acidified foods, it your responsibility to review production and processing records ensuring adherence to the scheduled processes, and any deviations from the scheduled processes are required to be identified and documented in a deviation file, in order to comply with 21 CFR 114.89, and 114.100(b) and (c).   
 
2.    Your firm failed to maintain processing records showing adherence to the scheduled processes, including records of critical factors intended to ensure a safe product as required by 21 CFR 114.100(b). Specifically, your firm had a scheduled process for “Black Bean and Corn Salsa” that was filed with the FDA on (b)(4), that listed a maximum equilibrium pH of (b)(4), and a hot fill and hold process of (b)(4)°F fill temperature with a (b)(4) hold (SID #(b)(4)). However, on December 10, 2014, you manufactured (b)(4) batches of “Black Bean and Corn Salsa” for which there are no processing records indicating the fill temperature or hold time for any of these batches. 
 
3.     Instruments used for measuring conditions that control or prevent the growth of microorganisms must be adequately maintained, to comply with 21 CFR 110.40(f). You have not calibrated your digital thermometer used to measure fill temperatures or your cook room probe thermometers, all of which are used to monitor critical factors. Further, your pH (b)(4) buffer solution used to calibrate your pH meter during our December 2015 inspection had expired in May 2015. 
 
Your response letter states that you purchased NIST-traceable thermometers to use when monitoring the fill temperature of acidified foods, and that you purchased a (b)(4) calibrator that you will use to calibrate your dial stem thermometers. You also stated that you have new buffer solution for your pH meter, and a new calibration form to document calibration of the pH meter. However, we cannot fully evaluate your response because of the lack of supporting documentation demonstrating your corrective actions. If you have implemented this correction, please submit documentation demonstrating such with your response to this letter.  
 
4.    You must maintain equipment, containers, and utensils used to hold and store food in a manner that protects against contamination, to comply with 21 CFR 110.80(b)(7). However, our Investigator noted apparent mold growth on drums of reworked food products and on pallets used to hold food containers stored in your cooler. 
 
Your response states that you destroyed the product contained in the drums, replaced the pallets, and created a pallet rotation procedure. However, we cannot fully evaluate your response because of the lack of supporting documentation demonstrating your corrective actions, such as photos or copies of your new procedure. Therefore, we will verify the effectiveness of your corrective actions during our next inspection. 
 
Misbranded Foods
 
Your “Black Bean & Corn Salsa,” “Sweet Potato Butter,” and “Sweet n Hot Pepper Relish” products are misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4. For example,
  • According to your formulation, the “Black Bean & Corn Salsa” product is manufactured using “(b)(4);” however, you fail to declare this ingredient on your finished product label.
  • According to your formulation, the “Sweet Potato Butter” product is manufactured using “(b)(4)” and “(b)(4);” however, you fail to declare these ingredients on your finished product label.
  • Your “Sweet n Hot Pepper Relish” product label declares “onion*” and “peppers*” (defined by the footnote, * dehydrated); however, this is not provided for under 21 CFR 101.4.
The above list is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure your establishment complies with all the requirements of the Act and federal regulations. You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective actions may subject your firm and products to further actions, such as emergency permit control, injunction, or seizure.
 
In addition, we have the following comments on your “Black Bean & Corn Salsa,” “Sweet Potato Butter,” and “Sweet n Hot Pepper Relish” product labels. 
  • The product labels include the statement “REFRIGERATE AFTER OPENING” within the Nutrition Facts panel, which is not in accordance with 21 CFR 101.9. The statement should be placed outside the Nutrition Facts panel.
  • The heading “Nutrition Facts” for these labels does not span the fill width of the nutrition panel, as required by 21 CFR 101.9(d)(2). 
  • The product labels fail to include a street address of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(d). 
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 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 U.S.C. 379j-31(a)(2)(B)). 
 
For a domestic facility, 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.
 
You should notify this office in writing within fifteen (15) business days from your receipt of this letter, of the specific steps you have taken to correct the noted deviations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions or steps towards long-term corrective actions, such as evidence that you are working with a Process Authority, documentation that you are adhering to your scheduled processes, or other corrective actions. If you cannot complete all corrective actions before you respond, we expect that you will explain the reason for your delay and state when you will correct the remaining deficiencies. 
 
Your written response should be sent to Jamie M. Bumpas, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, TX 75204. If you have questions regarding any issues in this letter, please contact Ms. Bumpas at 214-253-5336.
 
 
Sincerely,
/S/ 
Reynaldo R. Rodriguez, Jr.
Dallas District Director
 
 
Cc:     Ryan T. Funa, General Manager
          House of Webster, Inc.
          1013 North 2nd Street
          Rogers, Arkansas 72756

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