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WARNING LETTER

Aegle Nutrition LLC MARCS-CMS 546966 —

Recipient:
Recipient Name
John Ramsey
Aegle Nutrition LLC

1300 Hutton Drive, Suite 110
Carrollton, TX 75006
United States

Issuing Office:
Dallas District Office

United States

 

  

Black HHS-Blue FDA Logo

 

 

 
Office of Human & Animal Food Operations West, Division 3
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204 

 

July 6, 2018
 
Ref# CMS Case 546966
 
WARNING LETTER
 
UPS Overnight
 
John Ramsey, President
Aegle Nutrition, LLC
1300 Hutton Drive, Suite 110
Carrollton, Texas 75006
 
Dear Mr. Ramsey:
 
The U.S. Food and Drug Administration (FDA) inspected your facility, located at 1300 Hutton Drive, Suite 110, in Carrollton, Texas, where you manufacture a variety of dietary supplements, from November 28, 2017, through December 1, 2017. We then conducted a follow-up investigation from February 5 – 7, 2018, during which we obtained additional documents. The information obtained during the inspection and follow-up investigation revealed significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulation for dietary supplements, Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products 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)] because they have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements. 
 
Our investigator also identified significant violations of FDA’s Acidified Foods regulation, 21 CFR Part 114, which cause your acidified products to be adulterated within the meaning of section 402(a)(4) of 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. 
 
We have also reviewed the product labels of your Aegle Nutrition, LLC Tropical Oasis Ionized Trace Minerals, (b)(4), (b)(4) (grape flavor and strawberry melon flavor), Tropical Oasis Ultra Methyl B12, Tropical Oasis Premium Vitamin B12 products, and based on our review, we have concluded that these products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. 
 
You may find the Act and FDA regulations through links on the FDA’s home page at www.fda.gov.
 
Adulterated Dietary Supplements
 
The November 28, 2017 through December 1, 2017 inspection and February 5 – 7, 2018 follow-up investigation of your facility revealed the following significant violations of the CGMP requirements for dietary supplements:
 
1.    You failed to establish the following specifications for each component that you use in the manufacture of a dietary supplement:
  • Component specifications that are necessary to ensure that specifications for the identity purity, strength, and composition of dietary supplements manufactured using the components are met (21 CFR 111.70(b)(2));
  • Limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of dietary supplement to ensure the quality of the dietary supplement (21 CFR 111.70(b)(3)). 
Specifically, you have not established specifications for the identity, purity, strength, composition, and limits on contamination for the components that you use to manufacture your dietary supplements. During the inspection, you explained to our investigators that you rely on your supplier’s certificates of analyses for developing certain specifications, but these documents do not provide specifications for identity, purity, strength, composition, and limits on contamination that may adulterate or lead to adulteration of the finished batch of dietary supplement. Once you have established component specifications, you must determine whether those specifications were met, as required by 21 CFR 111.75(a). 
 
We acknowledge your response, dated December 15, 2017, in which you stated that your corrective action over the next (b)(4) months will include collecting samples from the highest volume suppliers and then sending them to a 3rd party lab for verification of purity, strength, composition, and contamination, and that you will use these results as new standards for (b)(4) Testing. Your response also stated that you will conduct additional testing as needed. We will verify the sufficiency of your corrective action during our next inspection.
 
2.    You failed to establish product specifications for each dietary supplement that you manufacture for the identity, purity, strength, and composition of the finished batch of dietary supplement, and for limits on those types of contamination that may adulterate, or lead to the adulteration of, the finished batch of dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, the documents you identified during the follow-up investigation as your master manufacturing records (MMRs) for your Tropical Oasis Ultra Methyl B12, Tropical Oasis Ionized Trace Minerals, and Tropical Oasis Vitamin B12 fail to provide specifications that ensure the identity, purity, strength, composition, or limits on contamination of the dietary supplements. Once you have established finished product specifications, you must, for a subset of finished dietary supplement batches that you identify through a sound statistical sampling plan (or for every finished batch), verify that your finished batch of dietary supplement meets product specifications for identity purity, strength, and composition, and for limits on contamination, as required by 21 CFR 111.75(c), and you must make and keep records of such specifications in accordance with 21 CFR 111.95(b)(1). 
 
We acknowledge your response, dated December 15, 2017; however, your response fails to demonstrate the sufficiency of your corrective actions in establishing product specifications.
 
3.    Your quality control personnel approved and released for distribution a batch of dietary supplement that did not meet established product specifications, in violation of 21 CFR 111.123(b)(2). Specifically, your quality control personnel reviewed the testing results and released two lots of dietary supplements that did not meet the specifications as outlined in your finished product specifications in your MMRs:
 
a.  Tropical Oasis Ultra Methyl B12, Lot Number TR92711701, was found to contain (b)(4) mcg of Vitamin B12, which does not meet the specification of (b)(4) mcg – (b)(4) mcg of Vitamin B12 as listed in the finished product specification in your MMR.   
b.  Tropical Oasis Vitamin B12, Lot Number TR51441701, was found to contain (b)(4) mcg of Vitamin B12, which exceeds the specification of (b)(4) mcg – (b)(4) mcg of Vitamin B12 as listed in the finished product specification in your MMR.   
 
We acknowledge your response, dated December 15, 2017; however, your response does not explain how you plan to ensure that your quality control personnel ensure that only products that meet established product specifications are approved and released for distribution.
 
4.    Your MMRs did not identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, and that the dietary supplement is packaged and labeled as specified in your MMR, as required by 21 CFR 111.205(b)(1). Specifically, your MMRs for Tropical Oasis Ultra Methyl B12 and (b)(4) did not include the specific information required under 21 CFR 111.210. In establishing MMRs for all your dietary supplements, your MMRs must include the following information as required by 21 CFR 111.210:
 
a.  Written specifications for each step, point or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR, as required by 21 CFR 111.210(h)(1).
b.  Written procedures for sampling and a cross-reference to procedures for tests or examinations, as required by 21 CFR 111.210(h)(2).
c.  Specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR, as required by 21 CFR 111.210(h)(3).
d.  Corrective action plans for use when a specification is not met, as required by 21 CFR 111. 210(h)(5).
e.  The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label, and the identity of each ingredient that will be declared on the ingredients list of the dietary supplement, as required by 21 CFR 111.210(d).
 
We acknowledge in your response, dated December 15, 2017, in which you stated that your master batch records have been updated to include label claim specifications. Your response fails to adequately address this violation because your updated MMRs do not include specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, and that the dietary supplement is packaged and labeled as specified in your MMR.
 
Acidified Foods
 
As an acidified food processor, you are also required to comply with the Act and the federal regulations relating to processing of acidified foods and CMPs. These regulations are described in 21 CFR Part 108, Emergency Permit Control, and 21 CFR Part 114, Acidified Foods. 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 the mandatory requirements of 21 CFR Part 114. 
 
During our inspection, the following CGMP violations of the Acidified Foods regulation were observed:
 
5.    As a commercial processor in the thermal processing of acidified foods, you must, not later than 60 days after registration and prior to the packing of a new product, provide the FDA information as to the scheduled processes including conditions for heat processing and control of pH, salt, sugar, and preservative level, 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 failed to file scheduled processes with FDA for the following products:       
  • (b)(4);
  • Tropical Oasis Ultra Methyl Vitamin B12;
  • Tropical Oasis Ionized Trace Minerals;
  • (b)(4);Tropical Oasis Vitamin B12. 
During the inspection, our investigator collected a sample of your Tropical Oasis Ultra Methyl B12. FDA analysis found that this is an acidified food product, with a pH values ranging from 3.02 – 3.17, and water activity values ranging from 0.978 – 0.98. 
 
We have reviewed your response, dated December 15, 2017, and acknowledge you have had some of your products re-evaluated by your new process authority, including the Tropical Oasis Ionized Trace Minerals, Tropical Oasis Vitamin B12, Tropical Oasis Ultra Methyl B12, (b)(4), and (b)(4). However, as of the date of this letter, you have not filed any of these scheduled processes with the FDA, and therefore, your response is inadequate. 
 
Scheduled process information for acidified foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic). More information on registration and filing can be found in the publication “Instructions for Establishment Registration and Process Filing for Acidified and Low-Acid Canned Foods,” available on FDA’s webpage at www.fda.gov.
 
6.    You did not fully reprocess, thermally process as a low-acid canned food under 21 CFR 113, or set aside for further evaluation as to any potential public health significance, a portion of food which deviated from a scheduled process, as required by 21 CFR 114.89. Specifically, your process authority letter, dated April 5, 2017, for (b)(4) requires you to process this product at a temperature of (b)(4)° - (b)(4)°F ((b)(4)° - (b)(4)°C) for (b)(4) minutes, and fill into 12 ounce containers at a temperature of (b)(4)° - (b)(4)°F ((b)(4)° - (b)(4)°C). However, on June 10, 2017 during the manufacture of (b)(4), lot number (b)(4), you filled the product into 1.7 ounce containers at a temperature of (b)(4)°F ((b)(4)°C). This fill temperature does not meet the fill temperature critical limits specified in your scheduled process. This a process deviation and must be evaluated by your firm’s process authority.
 
During the inspection, your Quality Manager stated to our investigator that the reason the fill temperature was lowered because the high fill temperature was compromising the integrity of the bottles. It was also stated to our investigator that your process authority provided verbal instructions to lower the fill temperature, but there were no records documenting this instruction. The fill temperature of (b)(4)°F has a very low lethality on acid tolerant pathogens.
 
We have reviewed your response, dated December 15, 2017, and acknowledge you have had (b)(4) re-evaluated by a new process authority. However, this response is not adequate because it does not address how you will document deviations from scheduled processes in the future, as required by 21 CFR 114.100(c).
 
7.    You failed to thermally process your acidified foods to an extent that is sufficient to destroy the vegetative cells of microorganisms of public health significance and those of nonhealthy significance capable of growing in the food, as required by 21 CFR 114.80(a)(1). Specifically, you manufactured three Tropical Oasis acidified food products without thermally processing the products:
  • Tropical Oasis Ionized Trace Minerals, Lot Number TR71941701
  • Tropical Oasis Vitamin B12, Lot Number TR51441701
  • Tropical Oasis Ultra Methyl B12, Lot Number Tr92711701
Furthermore, your process authority letters for these three products are incomplete in that the process authority states “Using the heat process, I have recommended,” but the process authority letter does not list any heat treatments on these three letters. 
 
We have reviewed your response, dated December 15, 2017, and acknowledge you have had some of your products evaluated by a new process authority. However, the new process authority letters for these three products also do not contain thermal process information, and contain the statement “Please note that each ingredient should be analyzed for potential microbial hazards. This is an estimated guideline.” As a manufacturer of acidified foods, it is your responsibility to ensure all scheduled processes for acidified foods are established by a qualified person with expert knowledge through appropriate training and experience in the acidification and processing of acidified foods, as required by 21 CFR 114.83. 
 
Misbranded Dietary Supplements
 
We have reviewed the product labels for your Tropical Oasis Ionized Trace Minerals, (b)(4), (b)(4) (grape flavor and strawberry melon flavor), Tropical Oasis Ultra Methyl B12, Tropical Oasis Premium Vitamin B12, and have determined that these products are misbranded dietary supplement under section 403 of the Act [21 U.S.C. § 343] in that they do not comply with the labeling requirements in 21 CFR Part 101.
 
1.    The Tropical Oasis Ionized Trace Minerals product is misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. 343 (q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. For example, the product label declares calcium, iron, zinc, iodine, phosphorus, magnesium, potassium, selenium, copper, manganese, chromium, molybdenum, and sodium as components of the Colloidal Minerals blend. As (b)(2)-dietary ingredients, these components along with their quantitative amounts per serving and percent daily values must be declared in the (b)(2)-dietary ingredient section of the Supplement Facts in accordance with 21 CFR 101.36(b)(2) and 101.36(c)(1).
 
2.    The (b)(4) (grape flavor and strawberry melon flavor), Tropical Oasis Ultra Methyl B12, Tropical Oasis Ionized Trace Minerals, and Tropical Oasis Premium Vitamin B12 products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the products are derived, as required by 21 CFR 101.4(h)(1).
 
3.    The (b)(4) (grape flavor and strawberry melon flavor) and (b)(4) products are misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the label bears or contains an artificial coloring, flavoring, or a chemical preservative, but does not bear labeling stating that fact. For example:
  • The (b)(4) product contains the ingredient “fruit punch,” but the label does not specify its function as a flavor.
  • The (b)(4) product contains chemical preservatives potassium sorbate and sodium benzoate but the label fails to include a separate description of their functions in accordance with 21 CFR 101.22(j).
  • The (b)(4) (grape flavor and strawberry melon flavor) product labels declare “natural color (vegetable)” in the ingredients statement. The term artificial color or artificial coloring means any ‘‘color additive’’ as defined in § 70.3(f) [21 CFR 101.22(a)(4)]. Because all added colors result in an artificially colored food, the label must not declare any added color as "natural."
4.    The (b)(4) (grape flavor and strawberry melon flavor) and (b)(4) products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. For example:
  • The (b)(4) (grape flavor and strawberry melon flavor) product labels declare the dietary ingredient Gaba, but this is not the common or usual name for this dietary ingredient. The ingredient should be listed as gamma-aminobutric acid.
  • The (b)(4) product label declares the term “Ticaloid,” which is not the common or usual name of an ingredient. Ticaloid is a registered trademark for gum blends, therefore the name of each gum should be listed.
5.    The (b)(4) product is misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.
 
This letter is not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm is in compliance with all requirements of the Act and all implementing regulations. You should take prompt measures to correct all violations described in this letter. Failure to promptly correct these violations may result in enforcement action by the FDA without further notice, including injunction or seizure. 
 
You should notify this office in writing within fifteen (15) business days from your receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent their recurrence. In your response, you should include documentation of your corrective actions. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrective actions before you respond, you should explain the reason for your delay and state when you will correct the remaining deficiencies. 
 
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 reinspection 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 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 Paul E. Frazier, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, TX 75204. If you have questions regarding any issues in this letter, please contact Mr. Frazier at 214-253-5340 or Paul.Frazier@fda.hhs.gov.
 
Sincerely,
/S/                                                                                   
Edmundo Garcia, Jr.
District Director
Program Division Director
Office of Human & Animal Food, WD3
 
   
Cc:      Texas Department of State Health Services
            Greg Wilburn, Inspection Unit Manager
            Food and Drug Inspections Branch
            1100 West 49th Street
            Austin, Texas 78756                                                  
 
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