Inspections, Compliance, Enforcement, and Criminal Investigations
Mobilia Fruit Farms Inc. 3/27/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
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
- 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.
- 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
- 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:
- 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).
- 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).
- 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.
- 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].
- 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.
- 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.
- 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.
- 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%).
- 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.