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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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W. H. Walker Sons Inc 1/31/13

  

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
 

 

January 31, 2013
 
WARNING LETTER NYK-2013-9
 
 
VIA UNITED PARCEL SERVICE
 
William Walker, President
W.H. Walker & Sons, Inc.
1153 Route 44 55
Clintondale, New York 12515
 
Dear Mr. Walker:
 
We inspected your juice processing facility, located at 1153 Route 44 55, Clintondale, New York on September 13, 21, and 26, 2012, and found that you have serious deviations from the FDA's juice processing regulation (21 CFR Part 120). These deviations cause your apple cider to be in violation of 21 CFR Part 120, promulgated under the authority of Section 361 of the Public Health Service Act (PHS Act). You can find the PHS Act and the juice HACCP regulation through links in FDA’s home page at www.fda.gov.
 
Additionally, our review of the labeling for your “Crow Hill” apple cider revealed that this product is misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] and the regulations for food labeling at Title 21, Code of Federal Regulations, Part 101 (21 CFR 101.4(b) and 101.30(b)(3)). You can find the Act and the FDA regulations through links in FDA's homepage at www.fda.gov.
 
We received your response dated October 11, 2012 concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
 
cGMP Violations
 
1)    You must take a corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 120.10. However, your firm did not take any corrective action to control the pertinent microorganism, Cryptosporidium parvum, when your process for pasteurized apple cider deviated from the critical limit in your HACCP plan of (b)(4)°F for (b)(4) seconds at the pasteurization critical control point. Specifically, your pasteurization records dated September 26, October 3, 5, 7, 17, and 24, 2011, show temperature drops below your critical limit of (b)(4)°F for (b)(4) seconds and you failed to take any corrective action.
 
Your October 11, 2012 response letter advising that you “allowed the deviation based on [your] belief that the ‘5 log’ reduction would be achieved at the (b)(4) degree temperature” and providing an internet article stating that an appropriate 5 log reduction in apple cider is (b)(4)°F for (b)(4) seconds, is inadequate because you failed to follow the corrective action listed in your HACCP plan to segregate the products produced on the dates above and re-pasteurize them. Further, the time temperature combination listed in the publication you included addressed only E. coli O157:H7 and did not address the pertinent microorganism in your HACCP plan, i.e. the most resistant to heat, Cryptosporidium parvum. The time temperature combination listed in this document of (b)(4)°F for (b)(4) seconds, is not adequate to control the pertinent microorganism, Cryptosporidium parvum. Consequently, you failed to assure that the products produced on those dates were not adulterated prior to shipping them into commerce.
 
2)    You must have a HACCP plan that lists monitoring procedures for each critical control point, to comply with 21 CFR 120.8(b)(4). However, your HACCP plan lists a monitoring procedure that does not ensure compliance with the critical limit. Specifically, your HACCP plan for apple cider lists a culling critical control point to prevent the hazard of patulin with a critical limit of less than (b)(4)% rotten fruit. However, your HACCP plan for apple cider lists the monitoring procedure, “(b)(4)” at the cull step critical control point that is not adequate to assure that the critical limit of “less than (b)(4)% rotten fruit” is being met. Moreover, your firm does not actually measure and/or maintain any monitoring record showing that you have met your critical limit described above.
 
We acknowledge the promised corrective actions and revised HACCP plan in your October 11, 2012 response letter. However, your letter is inadequate because you have failed to provide any evidence that you have implemented your culling critical control point and maintain any monitoring, verification, or corrective actions records for the culling critical control point. We further note that in your revised HACCP plan, you have not listed, under the four “Monitoring” columns (“What, How, Frequency, and Who”) any revisions to address the monitoring of rot at this critical control point . Monitoring of a critical limit at a critical control point  is not a “verification” activity.
 
Labeling violations
 
3)    Your “Crow Hill” apple cider is misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because the product is fabricated from two or more ingredients, and the label fails to declare the common or usual name of each ingredient as required by 21 CFR 101.4(b). Specifically, the information panel on your product label does not bear an ingredient statement that includes the added preservative Potassium Sorbate which is an ingredient in your product.
 
Under 21 CFR 101.30(b)(3), if the beverage contains 100 percent juice and also contains non-juice ingredients that do not result in a diminution of the juice soluble solids or, in the case of expressed juice, in a change in the volume, when the 100 percent juice declaration appears on a panel of the label that does not also bear the ingredient statement, it must be accompanied by the phrase “with added ___,” the blank filled in with a term such as “ingredient(s),” “preservative, “ or “sweetener” as appropriate…”
 
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the PHS Act and the juice HACCP regulation (21 CFR Part 120). You also have a responsibility to use procedures to prevent further violations of the Public Health Service Act and all applicable regulations.
 
You should take prompt action to correct these violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice. These actions include, but are not limited to, an injunction.
 
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things that you are doing to correct these deviations. You may wish to include in your response documentation such as your HACCP plan, copies of your Sanitation Standard Operating Procedure, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
 
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 July 2012 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 Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 622 Main Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Dean Rugnetta at (716) 846-6207 or E-mail at dean.rugnetta@fda.hhs.gov.
 
 
Sincerely,
/S/
Ronald M. Pace
District Director
New York District
 
cc:       
Amy O. Walker, Corporate Officer  
W.H. Walker & Sons, Inc.
1153 Route 44 55
Clintondale, New York 12515