Create-A-Pack Foods, Inc. 9/19/12

1. Your firm failed to process each thermally processed low-acid food packaged in hermetically sealed containers in conformity with at least the scheduled process as required by 21 CFR 108.35(c)(3)(i). For example, on 3/2/12, you filled (b)(4) Chocolate with temperatures between (b)(4)ºF into pouches; on 2/17/12 you filled (b)(4) Chocolate with temperatures between (b)(4)ºF into pouches; on 3/6/12 you filled (b)(4) Chocolate with temperatures between (b)(4)ºF into pouches; on 2/23/12 you filled (b)(4) Espresso with temperatures between (b)(4)ºF into pouches; and on 2/15/12 you filled (b)(4) Espresso with temperatures between (b)(4)ºF into pouches. Your scheduled processes for these products require a fill and hold time and temperature of (b)(4)ºF for (b)(4). We acknowledge your response indicates that you have submitted revised scheduled processes for these products which better reflect your batch processing and hot-fill operation, and we understand that you are monitoring and recording the fill temperature and the hold time and temperature during the manufacturing of these products. We will evaluate your firm’s adherence to the revised scheduled processes of these products during the next inspection.

2. Your firm failed to document the recording thermometer readings on the thermal processing records to ensure that the minimum process was met for the manufacture of your (b)(4) and (b)(4) syrup products as required by 21 CFR 113.100(a). For example, you manufactured the following (b)(4) products, but did not record the thermal process: (b)(4) Espresso, lot 12048; (b)(4) Espresso, lot 12017; (b)(4) Chocolate, lot 11325; and (b)(4) Chocolate, lot 12017. Also, you manufactured the following (b)(4) syrup products but did not complete the filler recorder temperature charts: lot 12068; lot 12039; lot 12067; and lot 12040. We acknowledge your firm’s corrective actions in that you have hired an outside service to fix, calibrate, verify and certify your chart recorders, and you have updated your records to include temperature monitoring from handheld devices for comparison. These corrective actions, as well as other record improvements, will be verified during the next inspection.

3. Your firm failed to maintain records to identify the initial distribution of the finished product to facilitate, when necessary, the segregation of specific food lots that may have become contaminated or otherwise rendered unfit for their intended use as required by 21 CFR 113.100(d). For example, you transferred lots of (b)(4) Espresso to your fulfillment center on 1/19/12 but did not retain lot traceability of that lot once it reached the fulfillment center. We acknowledge that your response indicates that you are tracking distribution of product to your order fulfillment center and also to the purchasing customers. These records will be verified during the next inspection. 

1. Your firm failed to provide FDA with the process and procedure information deemed necessary to determine the adequacy of the scheduled process as required by 21 CFR 108.25(c)(3)(ii). Specifically, your firm could not provide process information for obtaining commercial sterility of the cap and headspace during filling of your (b)(4) Water, (b)(4) products. At the time of the inspection, your firm’s procedure was to (b)(4). We acknowledge that your response indicates that you have modified your processes for your (b)(4) Water and (b)(4) products to include fill temperatures at a minimum of (b)(4)°F and (b)(4). We will verify your adherence to your current scheduled processes on file, specifically (b)(4), for your (b)(4) Water product (SID (b)(4)) and your (b)(4) varieties during the next inspection. In addition, at this time, there is no scheduled process on file for your (b)(4) Prune Juice product as the latest process (SID (b)(4)) was returned and deleted on April 6, 2012.

2. Your firm failed to test and examine containers often enough to ensure that the container suitably protects the food from leakage or contamination as required by 21 CFR 114.80(a)(4). For example, you manufactured numerous lots of (b)(4) Water, documenting cap failure with failure rates at times above (b)(4)%. This includes lots 10196, 10197, 10224, 10228, 10278, 10347, 10349, 11003, 11020, 11132, 11144, 11174, 11199, 11201 and 11308. In response to the high failure rate, you (b)(4). However, you continued to have seal failures on your product packaging and you continued to ship the affected product in interstate commerce. We acknowledge that your response indicates that you are currently conducting (b)(4) tests to monitor seal closures and that you have developed the specifications necessary to identify acceptable ranges in values. However, we consider (b)(4) tests inadequate to monitor container integrity and recommend evaluating seal integrity by using pull-up and security tests, which are more commonly used by industry for these types of containers.

3. As a commercial processor engaged in the processing of acidified foods, you must, not later than 60 days after registration and prior to the packing of a new product, provide FDA information as to the scheduled processes including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2). However, your firm has failed to file scheduled processes for the following (b)(4) brand acidified food products: (b)(4). We acknowledge that your firm submitted two scheduled processes for (b)(4) brand products (SID (b)(4) and SID (b)(4)); however, these processes were returned on March 28, 2012, and no revised processes have been received at this time.

4. Your firm failed to maintain records to identify the initial distribution of the finished product to facilitate, when necessary, the segregation of specific food lots that may have become contaminated or otherwise rendered unfit for their intended use as required by 21 CFR 114.100(d). For example, you transferred lots of (b)(4) acidified food products to your fulfillment center but did not retain lot traceability of those lots once they reached the fulfillment center. Those (b)(4) products include Vanilla, transferred on 1/3/12; Banana, transferred on 2/20/12; Orange, transferred on 1/12/12; Tropical, transferred on 2/18/12; Huckleberry, transferred on 2/21/12; Raspberry, transferred on 2/28/12; and Apple Cinnamon transferred on 3/23/12. We acknowledge that your response indicates that you are tracking distribution of product to your order fulfillment center and also to the purchasing consumers. These records will be verified during the next inspection.

1. Your firm failed to take corrective actions when a deviation from a critical limit occurred during the manufacture of (b)(4) Cherry Juice Concentrate as required by 21 CFR 120.10(a). For example, when you manufactured lot 12039 of (b)(4) Cherry Juice Concentrate in 32 oz. bottles on your (b)(4) heat exchanger and (b)(4) filler the (b)(4) exceeded the (b)(4) in your HACCP plan. You did not document a corrective action for this deviation. Furthermore, you distributed this product in interstate commerce. 

2. Your firm failed to implement your procedures, and to conduct them at the frequency at which they are to be performed, that are used to monitor each of the critical control points (CCPs) listed in your HACCP plan for your 100% cherry juice products as required by 21 CFR 120.8(a). For example, on 4/27/11 and on 5/11/11, you manufactured (b)(4) Cherry Juice Concentrate, only checking the (b)(4) as required under CCP (b)(4) of HACCP plan (b)(4) Also, you are not monitoring the (b)(4) machine to ensure the (b)(4). Your firm’s response states that you will monitor the (b)(4) of process. To ensure an adequate thermal process, we agree you need to revise your protocol to monitor the (b)(4) and that this parameter should be established within the context of a validated HACCP plan.

3. Your firm failed to validate your HACCP plan for 100% cherry juice products and your HACCP plan for 100% (b)(4) puree products as required by 21 CFR 120.11(b). You do not have documentation to ensure that your processes consistently treat your juice products with a 5-log reduction of public health organisms. Your firm’s response is inadequate because you failed to address the main concern of validating your 5-log reduction for both HACCP plans in order to be in compliance with this requirement of the regulation.

• “(b)(4): Cranberry has been shown to prevent urinary tract infections…in women.”

1. Your (b)(4) brand (b)(4) dietary supplement product is misbranded within the meaning of section 403(i)(2), 21 U.S.C. § 343(i)(2), of the Act in that your label fails to declare completely or accurately all of the ingredients used by your firm in the production of this product in accordance with 21 CFR 101.4(b). For example, the (b)(4) container label lists: “Fruit Pectin***Proprietary Herb Blend: Burdock (root), Milk Thistle (leaf), Nettle (leaf), Uva Ursi (leaf)***Creatine Monohydrate***Other Ingredients: Filtered Water, Fructose, Citric Acid, Natural Flavors, FD&C Yellow #6, FD&C Red #40 & Blue #2, Potassium Sorbate, Sodium Benzoate (as preservatives).” While the (b)(4) carton label lists: “Fruit Pectin***Proprietary Herb Blend: Burdock (root), Milk Thistle (leaf), Nettle (leaf), Uva Ursi (leaf)***Creatine Monohydrate***Other Ingredients: Filtered water, fructose, citric acid, natural flavor, vegetable juice for color, phosphoric acid, potassium sorbate, sodium benzoate.”

2. Your (b)(4) brand (b)(4) dietary supplement product is misbranded within the meaning of section 403(k) of the Act, 21 U.S.C. § 343(k), because the product bears or contains artificial coloring. The label of a food to which any coloring has been added shall declare the coloring in the statement of ingredients, 21 CFR 101.22(k). Specifically, your carton label and/or container label declares the ingredients FD&C Yellow No. 6, FD&C Red No. 40, FD&C Blue No. 2 and/or vegetable juice. For example, your product fails to declare the presence of FD&C Yellow No. 6, FD&C Red No. 40, and FD&C Blue No. 2 in the ingredient statement on the outer carton label. Additionally, your product fails to declare the presence of vegetable juice as a color additive on the finished container label.

• The (b)(4) sucrose solution, (b)(4) and (b)(4) brand (b)(4) dietary supplement product labels contain false statements. Specifically, these labels list water as “filtered” and “purified”; however, the water used in the manufacture of these products is not filtered or purified. 
• The (b)(4) Concentrate product label contains false and misleading statements. For example, the label lists the product as a “concentrate” but it is a single strength puree. Additionally, the label lists the product as “creamed” but the product is not creamed and does not contain cream.
• The ingredient statement for several varieties of the (b)(4) dietary supplements in bottles and pouches (i.e., Banana, Apple-Cinnamon, Raspberry, etc.) declares “(b)(4) ® (Fruit Juice, Natural Grain Dextrins)” as an ingredient. Based on prior inspections by FDA, (b)(4) consists of grape juice and rice dextrin; however, the label fails to identify these specific sub-ingredients as required by section 21 CFR 101.4(b).
• The (b)(4) Vanilla product label fails to include a complete domestic address or domestic phone number through which the responsible person, as described in section 761(b), may receive a report of a serious adverse event with such dietary supplement. 
• Label discrepancies exist between the container and carton label of your (b)(4) brand (b)(4) dietary supplement product. For example, the Amount per Serving values listed in the Supplement Facts panel of the container label are less than what is represented on the carton label. 
• Your (b)(4) brand (b)(4) contains false or misleading information regarding the presence of cranberry extract in the product. Cranberry or cranberry extract are not declared on either the container or the carton ingredient statements. A review of batch record 11002-001 at the time of inspection does not reveal cranberry or cranberry extract as an ingredient. The only ingredient listed to contain any cranberry derivative is component (b)(4) which is identified as “(b)(4),” not an extract as declared on your finished product labels. If this product does not contain cranberry extract, statements made in the labeling for these products asserting that such product contains cranberry extract are false and misleading.