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WARNING LETTER

Summit Beverage Group, LLC May 02, 2016

Summit Beverage Group, LLC - 05/02/2016


Recipient:
Summit Beverage Group, LLC


United States

Issuing Office:
Baltimore District Office

United States


  

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

Public Health Service
Food and Drug Administration
 Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707
 
WARNING LETTER
CMS#472341
 
May 2, 2016
 
Via UPS
 
Mr. Geoffrey S. Soares, C.E.O.
Summit Beverage Group, LLC
211 Washington Ave.
Marion, VA 24354
 
Dear Mr. Soares:
 
The United States Food and Drug Administration ("FDA" or "we") inspected your facility located at 211 Washington Ave, Marion, VA 24354 on May 4-8, and 15, 2015. Our inspection of your facility revealed that you failed to comply with the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, found in Title 21 of the Code of Federal Regulations, Part Ill (21 CFR Part 111). These violations cause your dietary supplement products "Urban Detox Pomegranate Cherry," "Urban Detox Goji Berry," and "Urban Detox Prickly Pear" to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Insofar as you intend to market your "function: Alternative Energy Strawberry Guava," "function: Alternative Energy Tropical Citrus," and "function: Alternative Energy Acai Grape" products as dietary supplements, these products are also adulterated within the meaning of section 402(g)(1) of the Act.
 
However, this letter should not be interpreted to mean that FDA agrees with the characterization of your "function: Alternative Energy Strawberry Guava," "function: Alternative Energy Tropical Citrus," and "function: Alternative Energy Acai Grape" products as dietary supplements. In fact, the labels for your "function: Alternative Energy Strawberry Guava," "function: Alternative Energy Tropical Citrus," and "function: Alternative Energy Acai Grape" products that we collected during our inspection revealed that these products are represented for use as conventional foods.1 The product labels bear "Supplement Facts" panels, however the label contains the statement "Function: Alternative Energy ... you've never tasted an energy drink this refreshing and delicious." This statement implies that these products are used as beverages, i.e., for taste and refreshment. In addition, according to your product labels, the 500 ml products have an 8 fl. oz. serving size (240 ml), which makes up a fairly significant part of the entire daily drinking fluid intake of an average person in the United States. Finally, the products are packaged in a similar manner to other beverage products.
 
Section 201(ff)(2)(B) of the Act provides that dietary supplements do not include products represented for use as conventional foods [21 U.S.C. § 321(ff)(2)(B)].  If your "function: Alternative Energy Strawberry Guava," "function: Alternative Energy Tropical Citrus," and "function: Alternative Energy Acai Grape" products are labeled as dietary supplements, they cannot also be represented for use as conventional foods because a product intended for use as a conventional food is not a dietary supplement. Such labeling would misbrand the products within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling would be false or misleading. Further, the introduction or delivery for introduction into interstate commerce, or causing thereof, of such misbranded products is prohibited under section 301(a) of the Act, 21 U.S.C. § 331(a).
 
The inspection also revealed that you have serious deviations from regulations for acidified foods (Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR Part 108) and Part 114, Acidified Foods (21 CFR Part 114). Accordingly, we have determined that your firm's acidified food products are 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)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. As an acidified foods processor, you are required to comply with the Act and the federal regulations relating to the processing of acidified foods and current good manufacturing practices. The Emergency Permit Control regulation was issued, in part, pursuant to section 404 of the Act (21 U.S.C. § 344). A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and mandatory requirements of 21 CFR Part 114.
 
You may find the Act and FDA's regulations through links on FDA's home page at www.fda.gov.
 
Our investigators' observations were presented to you on a Form FDA 483, lnspectional Observations, at the conclusion of the inspection on May 15, 2015. We have received your written responses dated July 3 and December 17, 2015, related to our investigators' observations noted on the Form FDA 483, Inspectional Observations, and address  your responses to each observation below.
 
Your significant violations are as follows:
 
Adulterated Dietary Supplements
 
To the extent you intend to market your products as dietary supplements, specific violations of 21 CFR Part III observed during the inspection include the following:
 
1.    You failed to take appropriate steps when dietary supplements did not conform to established specifications, as required by 21 CFR 111.77(a). Under that provision, when in-process specifications established under 21 CFR 111.70(c) are not met, quality control personnel must reject the dietary supplement unless such personnel approve a treatment, an in-process adjustment, or reprocessing that will ensure the quality of the finished dietary supplement. Our investigators found several instances where out-of-specification (OOS) results were obtained during in-process testing of dietary supplement products and your quality control personnel did not take the steps required by 21 CFR 111.77(a). Specifically,
 
a)  Your "Daily Beverage Batching Record" documents for March 2015 showed the following OOS results:
 
i.    Your "function: Alternative Energy Strawberry Guava" product, Batch Number 1562, did not meet specifications for (b)(4)
ii.    Your "function: Alternative Energy Tropical Citrus" product, Batch Number 1561, did not meet specifications for (b)(4)
iii.    Your "function: Alternative Energy Strawberry Guava" product, Batch Number 1563, did not meet specifications for (b)(4)
iv.    Your "function: Urban Detox Pomegranate Cherry" product, Batch Numbers 1559 and 1560, did not meet specifications for (b)(4)
v.    Your "function: Alternative Energy Acai Grape" product, Batch Numbers 1564 and 1565, did not meet specifications for (b)(4)
vi.    Your "function: Alternative Energy Tropical Citrus" product, Batch Number 1566, did not meet specifications for (b)(4)
 
b)  Your "FINISHED PRODUCT TESTING RECORD START-UP AND EVERY HOUR" documents for March 2015 showed the following OOS results:
 
i.    Your "function: Alternative Energy Strawberry Guava" product, Batch Numbers 1561, 1562 and 1563, did not meet specifications for (b)(4). Furthermore, these batches did not meet all three specifications at each (b)(4) check.
ii.    Your "function: Urban Detox Pomegranate Cherry" product, Batch Number 1559, did not meet specifications for (b)(4)
iii.    Your "function: Alternative Energy Acai Grape" product, Batch Number 1565, did not meet specifications for (b)(4)
 
We acknowledge that your response, dated July 3, 2015 included (b)(4). Additionally, we acknowledge that your response, dated December 17, 2015, stated that you have not run any dietary supplement products since the last FDA inspection and have therefore not been able to implement corrective actions. Before you resume your operations, you must be in full compliance with all applicable laws and regulations, including 21 CFR Part 111.
 
2.    You failed to establish all of the specifications that are required by 21 CFR 111.70.
Specifically,
 
a)  You failed to establish component specifications that are necessary to ensure that specifications for the purity, strength, and composition of the dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2).
Specifically:
 
•    The Master Manufacturing Record (MMR) for your "function: Alternative Energy Acai Grape" product identifies "(b)(4)" as an ingredient that requires potency testing. However, the MMR does not specify a potency test for this ingredient, and the field for "Spec potency" is blank.
 
•    The Master Manufacturing Record (MMR) for your "function: Alternative Energy Strawberry Guava" product identifies "(b)(4)" and "(b)(4)" as ingredients that require potency testing. However, on the MMRs for these products, the fields for "Spec potency" are blank. Furthermore, your firm does not perform testing of the "(b)(4)" ingredient.
 
•    The Master Manufacturing Record (MMR) for your "function: Alternative Energy Tropical Citrus" product identifies "(b)(4)" as an ingredient that requires potency testing. However, on the MMR for this product the field for "Spec potency" is blank.
 
b)  You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of each dietary supplement you manufacture, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of dietary supplement, as required by 21 CFR 111.70(e). Specifically, your "Function Dietary Supplement Finished Product Sampling Plan" states (b)(4). However, the "specification limits" field is blank. Your Regulatory Compliance Officer stated to our investigators that she reviews the finished product testing results by verifying that she has received a result for each finished product batch, but that she does not verify that specifications are met because there are no specifications.
 
Once you have established the above specifications, you must verify that the established specifications are met in accordance with 21 CFR 111.73 and 21 CPR 111.75(c), and you must make and keep records in accordance with 21 CPR 111.95(b).
 
We acknowledge that your response, dated July 3, 2015 indicated that you were in the process of getting specifications for these products. However, this same issue was cited previously on the Form FDA-483 issued to your firm on May 7, 2014. Additionally, we acknowledge that your response, dated December 17, 2015, stated that you have not run any dietary supplement products since the last FDA inspection and have therefore not been able to implement corrective actions. Before you resume your operations, you must be in full compliance with all applicable laws and regulations, including 21 CPR Part 111.
 
3.    Your batch production records (BPRs) failed to include complete information relating to the production and control of each batch as required by 21 CFR 111.255(b) and 21 CFR 111.260. Specifically, our investigators observed that of the 19 BPRs for your "function" line of dietary supplement products that were selected for review by our investigators, none of the BPRs included the following required information:
 
a)  An actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the MMR [21 CFR 111.260(k)(2)];
 
b)  Documentation that quality personnel approved and released, or rejected, the batch [21 CFR 111.260(1)(3)]
 
We acknowledge that your response, dated July 3, 2015, included (b)(4).
 
However, the (b)(4) does not require an actual or representative product label be included or an appropriate cross-reference specified. Additionally, we acknowledge that your response, dated December 17, 2015, stated that you have not run any dietary supplement products since the last FDA inspection and have therefore not been able to implement corrective actions. Before you resume your operations, you must be in full compliance with all applicable laws and regulations, including 21 CFR Part 111.
 
Acidified Food Violations
 
1)  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). Specifically, your firm has failed to file a scheduled process with FDA for the following acidified food product that you manufacture: Loves Beet Juice.
 
Our inspection also revealed that your firm manufactures a variety of beverages that may be considered acidified food products. Your firm is responsible for determining which regulations apply to the products that you manufacture, including whether any of these products are considered to be acidified foods, as defined in 21 CFR 114.3(b), subject to the applicable provisions of21 CFR parts 108 and 114. Accordingly, your firm should determine or have determined for you whether any additional products that you manufacture are acidified foods, and comply with the applicable requirements of21 CFR 108 and 114 including registration and process filing for those products that are determined to be acidified foods.
 
Scheduled process information for acidified or low-acid canned foods must be submitted on Form FDA 2541a (Process Filing for all Processing Methods Except Low Acid Aseptic). More information on filing can be found in the publication "Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods," available at: www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistrationf/AcidifiedLACFRegistration/ucm2007437.htm.
 
ln addition, our evidence indicates that your firm has manufactured acidified food products since at least January 2015 without registering your firm's information with FDA as required by 21 CFR 108.25(c)(1).
 
2)  Your firm failed to have scheduled processes established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods, as required by 21 CFR 114.83. Specifically, the scheduled processes for the following acidified food product was not established or evaluated by a process authority: Loves Beet Juice.
 
These acidified food violations are repeated from our previous inspection of your firm that ended May 7, 2014.
 
This letter is not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for ensuring that all of your products are in compliance with the statutes and regulations administered by FDA. You should take prompt action to correct these violations and prevent their reoccurrence. Failure to promptly correct these violations may result in regulatory action by FDA without further notice. Such action includes seizure of your products and/or injunction.
 
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the above violations and prevent them from recurring. Please include any documentation of your corrective actions. If you cannot complete all corrective actions within 15 working days, state the reason for the delay and the time within which these actions will be completed. In addition, due to the repeat nature of the violations listed above, we request that you and/or your representatives appear for a meeting at FDA's Baltimore District Office. We have tentatively scheduled June 9, 2016 at 1PM as the meeting date and time at FDA's Baltimore District Office. The Baltimore District office is located at 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If that date and/or time does not work, please suggest an alternative. At the meeting please be prepared to discuss in detail the steps you and your firm have taken to address all of the observations cited during our May 2015 inspection. Documentation, updated procedures, photographs or other relevant information will be useful to explain the corrections you have implemented or plan to take.
 
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. Are-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance 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 there-inspection and assessing and collecting there-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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection related costs.
 
Your written response should reference Warning Letter 472341 and be directed to: Mr. Ernest F. Bizjak, Compliance Officer, U.S. Food and Drug Administration, Baltimore District Office, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have any questions, please do not hesitate to contact Mr. Bizjak by calling (301)796-4081 or sending an email to ernest.bizjak@fda.hhs.gov.
 
Sincerely yours,
/S/
Evelyn Bonnin
District Director
Baltimore District Office
______________________________________________________________
 
1 See "Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages," available at http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm381189.htm.