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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Mobilia Fruit Farms Inc. 3/27/13

  

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

Public Health Service
Food and Drug Administration
 PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390 

 

WARNING LETTER
 
13-PHI-13
 
Delivered via United Parcel Service
 
 
March 27, 2013
 
 
Nicholas C. Mobilia, Co-Owner
Mobilia Fruit Farms, Inc.
12073 East Main Road
North East, PA 16428
 
Dear Mr. Mobilia:
 
The U.S. Food and Drug Administration (FDA) inspected your juice processing facility, located at 12073 East Main Road, North East, PA on October 24, 2012 through November 8, 2012. Our inspection found serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation Title 21 Code of Federal Regulations, Part 120. In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with 21 CFR Part 120, or otherwise operate in accordance with the requirements of Part 120, renders the juice 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).  Additionally, our inspection found significant deviations from the Current Good Manufacturing Practice (cGMP) regulations for food manufacturers, Title 21, Code of Federal Regulations, (21 CFR), Part 110. Accordingly, your pasteurized shelf-stable juice products are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. 
 
Furthermore, during the inspection, product labels for your shelf-stable Mobilia Farms 100% Pure Concord Grape Juice and shelf-stable Mobilia Farms 100% Pure Cherry Juice products (herein referred to as “Grape Juice” and “Cherry Juice”) were collected. We have reviewed these labels and found deviations from the food labeling regulations, 21 CFR, Part 101, that cause the products to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343].

You may find the Act, the FDA regulations, and the Juice Product Hazards & Controls Guidance: 1st Edition through links in FDA’s home page at www.fda.gov. The Juice HACCP Controls Guidance, First Edition is at the following link: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Juice/ucm072557.htm#iv

Juice HAACP
 
  1. You must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(a). However your firm does not have a HACCP plan for your Cherry Juice product, packaged in glass bottles, to control the food safety hazards of Listeria monocytogenes, metal fragments, and glass fragments.
  1. Your HACCP plan must, at a minimum, list all food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(b)(1). However, your HACCP plan for your Grape Juice product, packaged in glass containers, does not list the food safety hazard of glass breakage, at the (b)(4) CCP, as identified in your firm’s Hazard Analysis for this product. Furthermore, you have advised that you have (b)(4) at the filler and that you have no SSP or CCP to address this hazard. Once this hazard is identified in your Hazard Analysis as a hazard that is reasonably likely to occur, you must include control measures in your HACCP plan for the monitoring of the hazard. For information to control these food safety hazards, you may refer to the following link or The Juice HACCP Controls Guidance, First Edition: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Juice/ucm072557.htm#iv
  1. You must maintain sanitation standard operating procedures records that, at a minimum, document monitoring and corrections, to comply with 21 CFR 120.6(c). However, your firm did not maintain sanitation standard operating procedure records for the following areas of sanitation: the prevention of cross connections; maintenance of hand washing, hand sanitizing and toilet facilities; protection from adulterants; labeling, storage and proper use of toxic compounds; employee health conditions; and exclusion of pests.

In addition, your firm maintained sanitation standard operating procedure records that are not adequate for the“(b)(4).” Specifically, our review of several “(b)(4)” records revealed the following:

 
a.    On March 15, 2012, the portion of the record for the sanitizing of the (b)(4), used to manufacture Grape Juice, was not initialed as completed.
 
b.    On May 8, 2012, the portions of the record for the (b)(4) of the (b)(4) the correct concentration as a control measure, and the sanitation cycle of the (b)(4), used to manufacture Grape Juice, was not initialed as being completed.
 
c.    On May 14, 2012, the portion of the record for the (b)(4) remaining in the bottling area, used to manufacture Grape Juice, was not initialed as being completed.
 
d.    On July 30, 2012, the portion of the record for the sanitation cycle of the (b)(4), and the draining of sanitation solution from the system, after the manufacturing of Cherry Juice, was not initialed as being completed.
 
Labeling
 
  1. Your Grape Juice and Cherry Juice are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)], in that the labels fail to bear the nutrition information, as required by 21 CFR 101.9. For example,  
  • The Total Fat [21 CFR 101.9(c)(2)] and Sodium [21 CFR 101.9(c)(4)] contents are declared on the label; however, their Percent Daily Value is not declared as required by 21 CFR 101.9(c)(7)(ii).
  • You declare other nutrients (i.e. potassium) as provided in paragraph 21 CFR 101.9(f)(3) and make a nutrient content claim; however you fail to bear the statement, “Not a significant source of ____” (with the blank filled in with the name(s) of any nutrient(s) identified in 21 CFR 101.9(f) and calories from fat that are present in insignificant amounts).
  1. Your Grape Juice product is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], in that the label fails to bear the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5(a). 
  2. Your Grape Juice and Cherry Juice products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)], in that the labels fail to bear the net quantity of contents in accordance with 21 CFR 101.105(b)(2). Specifically, the labels for these products do not provide the net weight declaration in fluid ounces.
 
We acknowledge receipt of your letter dated, November 13, 2012, responding to the objectionable conditions cited on the FDA-483 Form, Inspectional Observations form issued at the close of our inspection on November 8, 2012. However, we have determined that your response is inadequate in that, although you state corrections will be achieved before February 1, 2013, you failed to include details of how each observation would be corrected and did not include any records for our review. In addition, your response did not include any reference concerning labeling deviations that were discussed with you during the course of the inspection and during the discussion with management meeting.
 
You should take prompt action to correct the violations described above. Failure to do so may result in regulatory action without further notice. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
 
Further, 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 related costs, 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.
 
We also note, and request that you address the following:
 
  1. The (b)(4) listed in your Grape Juice HACCP plan were not followed, as required by 21 CFR 120.8(a). Specifically:
  • Your HACCP plan for Grape Juice indicates that in the event there is a change in (b)(4), the HACCP plan would be (b)(4). On March 1, 2012 and March 2, 2012, changes were made to the (b)(4), through additions of (b)(4). A (b)(4) of your HACCP Plan was never conducted [FDA-483 Observation #3b].
  • Your HACCP plan for Grape Juice, identifies that a review of CCP records will be conducted (b)(4), and will be signed and dated by a formally (b)(4) individual. As of October 24, 2012, your firm had not implemented any (b)(4) procedures for your CCP listed in your plan [FDA-483 Observation #3c].
  • Your HACCP plan for Grape Juice identifies that a review of (b)(4) will be conducted (b)(4), and will be signed and dated by a formally (b)(4) individual. As of October 24, 2012, you have not implemented any (b)(4) procedures for your (b)(4) listed in your plan [FDA-483 Observation #3d].

 

  1. While the principal display panel on both your Grape Juice and Cherry Juice products bear the statement "100% PURE," this does not satisfy the requirement to bear a percent juice declaration.   The percentage must be declared by the words "Contains _ percent (or %) _ juice" or " _ percent (or %) juice," or a similar statement.
 
In addition,  if both products contain 100 percent juice and also contain non-juice ingredients (e.g. potassium metabisulfite) 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%  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 blanked filled in with a term such as "ingredient(s)," "preservative," or "sweetener," as appropriate (e.g., "100% juice with added sweetener"), except that when the presence of the non-juice ingredient(s) is declared as a part of the statement of identity of the product, this phrase need not accompany the 100% juice declaration [21 CFR 101.30(b)(3)].
 
  1. The label for your Grape Juice states “Every bottle of Mobilia Farms Pure Juices are grown, picked and squeezed by us, to provide you with the best tasting juice on the market”. Your firm’s “(b)(4)” document states that this product is manufactured from Grape Juice, single strength or Grape Juice from concentrate. You informed our investigator that the juice ingredient is purchased from a supplier; thus, the grapes are not grown and picked by your facility, as stated on the label.

 

  1. You provided our investigator with product labels and nutrient laboratory analysis conducted for your firm by (b)(4), for Grape Juice and Cherry Juice. A comparison of the data from the lab analysis revealed that the values differ from what is listed on your labels.

 

  1. Your HACCP plan “(b)(4)” section states that the Brix for your Grape Juice can range from (b)(4). Grape Juice must have at least the minimum Brix of 16. Any juice that is directly expressed from fruit or a vegetable (i.e. not concentrated or reconstituted) are considered to be 100% juice [21 CFR 101.30(h)(1)]. Per 21 CFR 101.30(h)(1), juices or juice beverages that are prepared from concentrate or reconstituted must meet a minimum brix value to be considered single-strength (100%).

 

  1. Your HACCP plan “(b)(4)” states in the “(b)(4)” that “(b)(4)” is used to treat the fruit. If (b)(4) is used in the manufacturing of your Cherry Juice and Concord Grape Juice products, then the ingredient must be declared as required by 21 CFR 101.4, unless it is exempted by 21 CFR 101.100. In accordance with 21 CFR 101.100(a)(4), any sulfiting agent that has been added to any food and has no technical effect in that food will be considered to be present in an insignificant amount only if no detectable amount of the agent is present in the finished food. A detectable amount of sulfating agent is 10ppm or more of the sulfite in the finished food.   
 
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 records, verification records, labels, 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 juice HACCP regulation (21 CFR Part 120), the Current Good Manufacturing Practice regulation (21 CFR Part 110), and the Food Labeling regulations (21 CFR, Part 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
Your written response should be sent to Richard C. Cherry, Compliance Officer at the address noted above. If you have questions regarding any issues in this letter, please contact Mr. Cherry  at 215-717-3075 or by e-mail at Richard.Cherry@fda.hhs.gov
                                                                        
Sincerely,
/S/
Kirk D. Sooter
District Director
Philadelphia District
 
cc:       
Kathleen M. Mobilia, Co-Owner
Mobilia Fruit Farms, Inc.
12073 East Main Road
North East, PA 16428
 
Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
Attention: Dr. Lydia Johnson, Director
2301 North Cameron Street
Harrisburg, PA 17110-9408