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WARNING LETTER

Pat's Exotic Beverages, Inc. 07/10/2015

Pat's Exotic Beverages, Inc. - 10/07/2015


Recipient:
Pat's Exotic Beverages, Inc.


United States

Issuing Office:
New York District Office

United States


  

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

Public Health Service
Food and Drug Administration
 New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433 

 

October 7, 2015
 
 
WARNING LETTER NYK-2015-48
 
 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Ms. Cordelia P. Lindsay
President
Pat’s Exotic Beverages, Inc.
2919 Tiemann Avenue
Bronx, NY 10469-3321
 
Dear Ms. Lindsay:  
 
We inspected your juice processing facility, located at 2919 Tiemann Avenue, Bronx, NY 10469-3321 on January 21, 2015 – February 11, 2015. The inspection revealed serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation [21, Code of Federal Regulations (CFR) Part 120].  At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, listing the violations found at your firm.
 
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 this part, renders the juice products adulterated within the meaning of Section 402(a)(4) of the Food, Drug and Cosmetic Act [21 U.S.C. § 342(a)(4)]. Accordingly, your tamarind, carrot, carrot-lime, carrot-beet, and cucumber 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. You may find the Act, FDA’s juice HACCP regulations, and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda.gov.
 
Additionally, review of your labels revealed violations that render these products misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343].
 
We acknowledge receipt of your response, dated February 23, 2015. Your response included various documents, including revised HACCP plans and other HACCP related documentation. However, review of the documentation revealed that your response was not adequate, as further described in this letter.  
 
These violations include, but are not limited to, the following:
 
Juice HACCP
 
1.    You must include in your hazard analysis and HACCP plan control measures that will consistently produce, at a minimum a 5-log reduction of the pertinent microorganism for at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, to comply with 21 CFR Part 120.24(a). The "pertinent microorganism" is defined as "the most resistant microorganism of public health significance that is likely to occur in the juice,” 21 CFR 120.24(a). Your firm does not have evidence that the pasteurization treatment performed on your juice products (i.e., carrot juice, carrot-lime juice, carrot-beet juice, cucumber juice, and tamarind juice) achieves a minimum 5-log reduction of the most pertinent organism. Your firm failed to produce any validation studies required by 21 CFR 120.11 showing your process to be adequate. Further, as a result of several instances of botulism poisoning from refrigerated carrot juice, the Agency recommends that a process be applied that will ensure that Clostridium botulinum growth and toxin production will not occur should the juice, as offered for sale by the processor, be kept un-refrigerated in distribution or by the consumer. This guidance can be found at: http://www.fda.gov/Food/GuidanceRegulation/Guidance DocumentsRegulatoryInformation/Juice/ucm072481.htm.
 
We have reviewed your response and have determined that it is inadequate to correct the violations. You did not include in your response any documentation to verify that you have implemented a minimum 5-log reduction of the most pertinent organism process for your products. Your response indicates you plan to submit your plans to (b)(4), but there is no timeframe for doing so. Until your validation studies are completed, we cannot be assured that your pasteurization process is capable of achieving a minimum 5-log pathogen reduction of the most pertinent organism.
 
2.    You must apply a process directly to your juice that will consistently produce a minimum 5-log reduction of the pertinent microorganism for the shelf life of the product when stored under normal or moderate abuse conditions, to comply with 21 CFR 120.24(a). Although your revised HACCP plan dated February 19, 2015, for 100% fresh carrot juice used to manufacture carrot and carrot-beet juice products, lists that the juice is pasteurized, during the inspection of your facility our investigator observed your firm dumping peeled, whole, raw carrots in boiling water until the internal temperature of (b)(4) reached (b)(4), which was approximately (b)(4). Thereafter, the juice was then (b)(4) from the heated whole carrots, and then (b)(4) to (b)(4). The carrot juice was then used to make your carrot and carrot-beet juice products. Moreover, because carrots and beets are low acid foods, Clostridium botulinum is the pertinent microorganism, and therefore, your pasteurization conditions are not adequate to eliminate spores of this microorganism. In addition, there is no time/temperature step after the raw carrots are blended with other ingredients (i.e., thermally processed beet juice and sugar). Furthermore, your juice is (b)(4), which is inadequate to treat the container and headspace in order to address potential recontamination of the product through the packaging material. Therefore, your firm’s carrot and carrot-beet juice products are not processed with an adequate pasteurization step to ensure a minimum 5-log pathogen reduction.  Because botulism is a serious foodborne illness, FDA recommends that manufacturers of low acid juices adopt stronger control measures as described in the FDA Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low Acid Juices to ensure the safety of these types of products. As relayed in this guidance, “This objective could be achieved by any validated treatment method that is effective for this purpose, e.g., acidification of the juice to a pH of 4.6 or below, thermal treatment of the juice.”
 
We have reviewed your response and have determined that it is inadequate to correct the violation. Although you provided a document entitled “Pasteurization Record” with your response, you did not provide evidence to verify that you have implemented a pasteuriza- tion step with a minimum 5-log reduction for your juice products.
 
3.    You must have a HACCP plan that lists all of the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(b)(1). However, your firm’s revised HACCP plans for carrot juice dated February 19, 2015, and carrot-beet juice dated February 18, 2015, do not list the food safety hazard of allergens (i.e., milk). Your carrot juice and carrot-beet juice products contain milk, an allergenic ingredient that can cause serious allergic reactions in some individuals.
 
We have reviewed your response and have determined that it is inadequate to correct the violations noted. Although you revised your HACCP plans to address allergens, the plans do not specify the type of allergens (i.e., milk).
 
4.    Your HACCP plans must list all critical control points for each identified hazard, to comply with 21 CFR 120.8(b)(2). However, your firm’s revised HACCP plan dated February 11, 2015, for your cucumber juice does not list a critical control point for controlling the food safety hazard of metal fragments. Specifically, you have identified damage from your metal strainer as a significant hazard; therefore, you should identify a critical control point to control the food safety hazard of metal fragments.
 
5.    You must have a HACCP plan that lists the procedure(s) and frequency(ies) that will be used to monitor each of the critical control points to ensure compliance with the critical limits, to comply with 21 CFR 120.8(b)(4). However, your firm’s revised HACCP plans for carrot juice dated February 19, 2015, carrot-beet juice dated February 18, 2015, carrot-lime juice dated February 12, 2015, tamarind juice dated February 24, 2015, and cucumber juice dated February 11, 2015, list the following monitoring procedure(s)/ frequency(ies) that are not adequate to ensure compliance with the identified critical limits.
 
a.    Your monitoring procedure/frequency at the “(b)(4)” critical control point to control Clostridium botulinum in your carrot, carrot-beet, and carrot-lime juices, and E. coli in your cucumber and tamarind juices lists that you will (b)(4) the (b)(4), for every batch. However, you do not indicate the method used to monitor the temperature, where the temperature is to be taken, and what device is to be used. In addition, FDA recommends you continuously monitor both the time and temperature of the juice heat treatment to ensure that your process is achieving a minimum 5-log pathogen reduction. 
 
b.    Your monitoring procedure/frequency at the “(b)(4)” critical control point to control Clostridium botulinum in your carrot, carrot-beet, and carrot-lime juices, and E. coli in your cucumber and tamarind juices, lists that you will (b)(4) the (b)(4) for every batch. However, you do not indicate the method used to monitor the temperature, where the temperature is to be taken, and what device is to be used.
 
c.    Your monitoring procedure at the “(b)(4)” critical control point to control undeclared allergens in your carrot juice and carrot-beet juice products lists that you (b)(4) that the labels declare “nuts” for every batch. However, these products contain the allergen, milk; therefore, you should ensure that your label declares milk.
 
6.    Since you chose to include corrective actions in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 120.8(b)(5). However, your corrective action plans listed in your revised HACCP plans for carrot juice dated February 19, 2015, carrot-beet juice dated February 18, 2015, carrot-lime juice dated February 12, 2015, tamarind juice dated February 24, 2015, and cucumber juice dated February 11, 2015 are not appropriate.
 
a.    Your corrective action at the (b)(4)” critical control point states you will (b)(4) your product. However, it is unclear how you will determine whether to (b)(4) or (b)(4) the product. In addition, you do not state how you will correct the cause of the violation as required by 21 CFR 120.10(a).
 
b.    Your corrective action at the (b)(4)” critical control point states you will (b)(4) the product and (b)(4). However, it is unclear how you will determine whether to (b)(4) the product or (b)(4). In addition, you do not state how you will correct the cause of the violation as required by 21 CFR 120.10(a).
 
We have reviewed your response and have determined that it is inadequate to correct the violations noted. Although you revised your corrective actions in your HACCP plans at the (b)(4)” and “(b)(4)” critical control points, you still did not state how you will correct the cause of the violations.
 
Comment:
 
The monitoring procedure/frequency at the “(b)(4)” critical control point to control Clostridium botulinum in your carrot, carrot-beet, and carrot-lime juices, and E. coli in your cucumber and tamarind juices, lists that you will (b)(4) the (b)(4) temperature (b)(4) (i.e., “(b)(4)”). However, you do not indicate the method of (b)(4) the (b)(4) and what device is to be used. In addition, (b)(4) during refrigerated storage do not ensure that products are not exposed to elevated temperatures for extended time periods. Therefore, you may want to consider using a continuous monitoring device such as a continuous temperature data logger for monitoring refrigerated storage. Additionally, you may also want to conduct a daily check of the (b)(4) to ensure that proper temperatures have been maintained, and a daily check of the monitoring equipment itself to ensure that it is operating properly.
 
Misbranded Food
 
1.    Your “Pat’s Exotic Tamarind,” “Pat’s Exotic Beverage Carro-Beet,” “Pat’s Exotic Beverage Cucumber,” and “Pat’s Exotic Beverage Carrot/Lime” juice products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they purport to be beverages containing vegetable or fruit juice but fail to bear a percentage, as required by 21 CFR 101.30. For example, the products purport to be beverages containing fruit juice and/or vegetable juice, but the labels fail to bear a percentage declared by the words "Contains_ percent (or %)_ juice" or a similar phrase with the first blank filled in with the percentage of the juice and the second blank (if used) filled in with the name of the particular fruit or vegetable (e.g., "Contains 50 percent apple juice" or "50 percent juice") as required by 21 CFR 101.30(b)(1).
 
2.    Your “Pat’s Exotic Tamarind,” “Pat’s Exotic Beverage Carro-Beet,” “Pat’s Exotic Carrot,” “Pat’s Exotic Beverage Cucumber,” and “Pat’s Exotic Beverage Carrot/Lime” juice products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. For example,
  • The product labels fail to declare a “reference amount customarily consumed” (RACC) that is appropriate to the food as defined within 21 CFR 101.12. The “Pat’s Exotic Beverage Carro-Beet,” “Pat’s Exotic Beverage Cucumber,” and “Pat’s Exotic Beverage Carrot/Lime” product labels fail to declare a metric equivalent or the correct metric equivalent for the serving size. The “Pat’s Exotic Tamarind” and “Pat’s Exotic Carrot” product labels declare (230ml); however, the appropriate RACC for Carbonated and noncarbonated beverages, wine coolers, water is 8 fl. oz. (240 mL).
  • The “Pat’s Exotic Tamarind” and “Pat’s Exotic Carrot” product labels fail to declare transfat as required by 21 CFR 101.9(c)(2)(ii).
  • The “Pat’s Exotic Beverage Cucumber,” and “Pat’s Exotic Beverage Carrot/ Lime” juice product labels fail to declare the number of servings per container as required by 21 CFR 101.9(d)(3)(ii) and (b)(8).
  • The “Pat’s Exotic Beverage Carrot/Lime” and “Pat’s Exotic Beverage Cucumber” product labels fail to include the number of servings per container in accordance with 21 CFR 101.9(d)(3)(ii) and (b)(8).
3.    Your “Pat’s Exotic Beverage Cucumber” juice 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 a chemical preservative but does not bear labeling stating that fact. Specifically, the product contains the chemical preservatives sodium benzoate, sodium metabisulfite, and sodium sulfite but fails to bear labeling stating that fact in accordance with 21 CFR 101.22(j).
 
In accordance with 21 CFR 101.22(j), the label of a food to which a chemical preservative(s) is added shall bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g. “preservative,” “to retard spoilage,” “a mold inhibitor,” “to help protect flavor,” or “to promote color retention.
 
4.    Your “Pat’s Exotic Tamarind” and “Pat’s Exotic Carrot” juice products are misbranded within the meaning of Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because the product labels fail to include an appropriate statement of identity on the Principal Display Panel, as required under 21 CFR 101.3. Specifically, the products are identified on the label as “Pat’s Exotic Tamarind” and “Pat’s Exotic Carrot.”
 
5.    Your “Pat’s Exotic Beverage Cucumber” juice product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false and misleading. Specifically, the product label declares “No Preservative.” However, sodium benzoate, sodium metabisulfite, and sodium sulfite, which are preservatives, are declared in the ingredient statement. 
 
We offer the following comments about your product labels:
  • The “Pat’s Exotic Beverage Carro-Beet,” “Pat’s Exotic Beverage Cucumber,” and “Pat’s Exotic Beverage Carrot/Lime” product labels declare cholesterol in term of “grams (g)” instead of “milligrams (mg),” which is not in accordance with 21 CFR 101.9(c)(3).
  • The “Pat’s Exotic Beverage Cucumber” and “Pat’s Exotic Beverage Carrot/Lime” juice product labels declare 1% DV of protein; however, there is 0g of protein.
  • The “Pat’s Exotic Carrot” juice product declares “vanilla flavoring” and its sub-ingredients in the ingredients statement; however, it is not declared in accordance with 21 CFR 101.22.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, including, without limitation, injunction and seizure under sections 302 and 304 of the Act [21 U.S.C. §§ 332 and 334].
 
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act, the juice HACCP regulation (21 CFR Part 120), and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. You may wish to include in your response documentation such as your revised HACCP plans 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 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 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 January 21, 2015-February 11, 2015 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: Lillian C. Aveta, Compliance Officer, New York District Office, Food and Drug Administration, 158-15 Liberty Ave., Jamaica, NY 11433. If you have any questions about the content of this letter please contact Ms. Aveta at 718-662-5576 or E-mail at lillian.aveta@fda.hhs.gov.
 
                                                           
Sincerely,
/S/ 
Ronald M. Pace
District Director
New York District