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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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AFP Advanced Food Products Llc 12/13/13

  

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

Public Health Service
Food and Drug Administration
 
Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142

 

December 13, 2013
 
 
WARNING LETTER
 
 
via UPS Overnight Delivery                                  
Refer to MIN 14 – 04
 
 
Miroslav Hosek
President
AFP Advanced Food Products LLC
158 West Jackson Street
New Holland, Pennsylvania  17557
         
Dear Mr. Hosek:
 
The Food and Drug Administration (FDA) conducted an inspection of your aseptic manufacturing facility located at 600 First Avenue West, Clear Lake, Wisconsin, on June 24-28 and July 11, 2013. The inspection found that your firm aseptically processes and packages nutritional drinks, puddings, cheese sauces, chilis, dips, and salsas packaged in various can sizes, as well as acidified products including cheese sauces, cream cheeses, dips and salsa packaged in plastic cups and flexible pouches. The inspection revealed that you have significant deviations from the Low-Acid Canned Foods (LACF) regulations, Title 21, Code of Federal Regulations, Part 113 (21 CFR 113).    
 
As a manufacturer of low-acid canned food products, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to the processing of acidified food and low-acid canned food products. These regulations are described in 21 CFR 108, Emergency Permit Control, and 21 CFR 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344. A temporary emergency permit may be required for low-acid canned foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.35, including registration and filing of process information, and the mandatory requirements in 21 CFR 113. 
 
Based upon certain criteria in 21 CFR 113, low-acid canned foods may be adulterated within the meaning of section 402(a)(4), 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and the acidified and low-acid food regulations through links on FDA’s Internet home page at www.fda.gov.
 
We received your letter dated July 23, 2013; our comments follow. Your firm’s significant deviations from the Low-Acid Canned Foods regulations, 21 CFR 113, include:  
 
1.    Your firm failed to equip each product sterilizer with a temperature-indicating device that is accurate to 1°F or 0.5°C as required by 21 CFR 113.40(g)(1)(i)(A)(4).
 
Specifically, the (b)(4) digital temperature-indicating device that was used as the reference thermometer for the aseptic processors for the 5 oz. (b)(4) filler, 9 oz. (b)(4) filler, 11 oz. (b)(4) filler, 1 gal. (b)(4) filler, and (b)(4) Filler between April 4, 2010, and June 24, 2013, has an accuracy of (b)(4)°F.  Further, the (b)(4) thermocouple, which is utilized to feed the temperature-indicating devices currently in use, has standard limits of error (b)(4)°F) or (b)(4)%, whichever is greater. 
 
Your response is inadequate in that you have identified the (b)(4) Circular Chart as the reference device and the (b)(4) digital display as the indicating device.  The temperature-indicating device is the “official thermometer” for indicating the processing temperature and the chart is adjusted to it and must not read higher during processing. The response you have provided mirrors the answer you submitted on October 9, 2012, in response to this same observation noted at the conclusion of the September 2012 inspection of your facility. Your proposed corrective action at that time included discontinuing the use of the (b)(4) digital indicating thermometers because of temperature fluctuations between the device and the (b)(4) Circular Chart.  We are concerned with your continued lack of compliance with this requirement in 21 CFR 113.40(g)(1)(i)(A)(4).  We remind you that it is your responsibility to fully understand your process and that you are expected to achieve and maintain compliance with applicable regulations. Additionally, you need to ensure that your products were processed at or above the minimum filed scheduled processing temperatures.
 
2.    Your firm failed to ensure that the temperature recording chart is adjusted to agree as nearly as possible with, but in no event higher than, the temperature-indicating device as required by 21 CFR 113.40(g)(1)(i)(B)(3).
 
Specifically, the readings for the temperature recording device recorded 1°F higher than the corresponding temperature-indicating device reading from 21:23 on June 25, 2013, through 11:05 on June 26, 2013. On June 25, 2013, your firm was aseptically processing and packaging Nacho Cheese Sauce in #10 cans, and on June 26, 2013, your firm was aseptically processing and packaging Sharp Cheddar Cheese Sauce in #10 cans. 
 
Your response indicates the Controls Technician made the necessary adjustments to bring the system into compliance, assuring adjustments were not made while the system was on product. Your response is inadequate in that it does not address the cause of the deviation.
 
This letter is not intended to be an all-inclusive list of deficiencies. It is your responsibility to ensure that all of your products comply with the Act, the low-acid canned food regulations (21 CFR 108 and 113), the Current Good Manufacturing Practice regulation (21 CFR 110), and other applicable regulations. As a result of your previous inspectional findings and your continued non-compliance with FDA regulations we find it necessary to put you on notice that continued non-compliance with FDA regulations may result in further regulatory action including seizure and/or injunction. 
 
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining violations.
 
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 non-compliance 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 non-compliance 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 the Food and Drug Administration, Attention: Demetria L. Lueneburg, Compliance Officer, at the address listed on this letterhead. If you have any questions with regard to this letter, you may contact Ms. Lueneburg at (612) 758-7210.
 
Sincerely,
/S/ 
Michael Dutcher, DVM
Director
Minneapolis District