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WARNING LETTER

Nutrafill, LLC


Recipient:
Nutrafill, LLC


United States

Issuing Office:
Atlanta District Office

United States


  

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

Public Health Service
Food and Drug Administration
 
Atlanta District Office
60 8th St., NE
Atlanta, GA 30309 

December 18, 2015 

VIA UPS OVERNIGHT DELIVERY
 
Dallas L. Boley, Owner
Nutrafill, LLC
655 Crawford Street, NE
Dawson, GA 39842
WARNING LETTER
(16-ATL-05)
 
Dear Mr. Boley,
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 655 Crawford Street, NE on June 1-4, 2015. On June 18, 2015 a FDA Investigator also collected labels for products you manufacture including "Natural Solutions Manganese Plus," "The Medicine Man's Complete Nutrients for Liver," The Medicine Man's Ginkgo Biloba," and "The Medicine Man's Olive Leaf Extract." Based on the inspection and a review of your product labels, we have identified serious violations of the Federal Food, Drug, and Cosmetics Act (the Act). You can find the FDA regulations and the Act through links on FDA's home page at http://www.fda.gov.
 
We have reviewed your written response dated June 16, 2015, submitted in response to the FDA-483 issued to you at the close of the inspection. We have included some detailed comments regarding your response below.
 
UNAPPROVED NEW DRUG
 
We reviewed your product label for "Natural Solutions Manganese Plus" following an inspection of your facility at 655 Crawford Street, NE on June 1-4, 2015. The claims on your product label establish that the product is a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act.
 
Examples of some of the claims on your product label that provide evidence that your "Natural Solutions Manganese Plus" product is intended for use as a drug include:
 
"Natural Solutions Manganese Plus":
 
• "[I]s a powerful anti-inflammatory."
 
Your product is not generally recognized as safe and effective for the above- referenced use and, therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
 
ADULTERATED DIETARY SUPPLEMENTS
 
Even if your "Natural Solutions Manganese Plus" product did not have therapeutic claims which make it an unapproved new drug, the product would still be an adulterated dietary supplement within the meaning of section 402(g)(1) of the Act [21 U.S.C. §342(g)(1)] because the product has been prepared, packed, or held under conditions that do not meet the current good manufacturing practice ( cGMP) regulations for dietary supplements in Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111). Further, your "The Medicine Man's Ginkgo Biloba," "The Medicine Man's Olive Leaf Extract" and "The Medicine Man's Complete Nutrients for Liver" products are also adulterated within the meaning of section 402(g)(1) [21 U.S.C. § 342(g)(1)] of the Act for the reasons described above.
 
During the June 1-4, 2015 inspection our FDA Investigators observed the following serious violations of the cGMP regulations for dietary supplements (21 CFR Part 111 ):
 
1.    You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making disposition decisions, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103 and 21 CFR 111.140(b). Specifically, during our inspection, Mr. Thomas N. Burnett, III, General Manager (Mr. Burnett) informed our investigators that there are no written procedures for quality control.
 
Based on the information you provided in your response dated June 16, 2015, we are not able to assess the adequacy of your corrective action to establish written procedures for quality control. Although you indicate in the response that you will work with your consultant to draft and implement SOPs for the Quality Control Department, you did not provide supporting documentation to demonstrate that corrective action was taken. We intend to verify the adequacy of that corrective action and other corrective actions at a future inspection.
 
2.    You failed to establish specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(a). Specifically:
 
• You failed to establish specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b).
 
• You failed to establish in-process specifications for any point, step, or stage in the master manufacturing record where control is necessary to ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplements, as required by 21 CFR 111.70(c)(1).
 
• You failed to establish specifications for dietary supplement labels and for packaging that may come in contact with the dietary supplements, as required by 21 CFR 111.70(d).
 
• You failed to establish specifications for each dietary supplement that you manufacture for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e).
 
During the inspection, our Investigators found that your firm has not established product specifications for the identity, purity, strength, composition, and contamination limits of the finished product batches of your dietary supplements. Additionally, your firm has not established specifications for components, in-process manufacturing, labels and packaging. Once you have established the above specifications, you must determine whether the specifications have been met as required by 21 CFR 111.73. We also note that you must make and keep records for established specifications, as required by 21 CFR 111.95(b)(1).
 
Based on the information you provided in your response dated June 16, 2015, we are not able to assess the adequacy of your corrective action to establish specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement. Although you indicate in the response that you will work with your consultant to put in place specifications, you did not provide supporting documentation to demonstrate that corrective action was taken. We intend to verify the adequacy of that corrective action and other corrective actions at a future inspection.
 
3.    Your master manufacturing records (MMRs) for your "The Medicine Man's Ginkgo Biloba," "The Medicine Man's Complete Nutrients for Liver," and "The Medicine Man's Manganese Plus" products failed to include all of the information required by 21 CFR 111.210.
 
Specifically, your MMRs failed to include the following:
 
a.    A statement of an intentional overage amount of a dietary ingredient as required by 111.210(e);
 
b.    Written instructions, including specifications for each point, step 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 master manufacturing record, as required by 21 CFR 111.210(h)(1); and
 
c.    Procedures for sampling and a cross-reference to procedures for tests or examinations, as required by 21 CFR 111.210(h)(2).
 
Based on the information you provided in your response dated June 16, 2015, we are not able to assess the adequacy of your corrective action to modify your existing MMRs. Although you indicate in the response that you will work with your consultant to modify your existing MMRs, you did not provide supporting documentation to demonstrate that corrective action was taken. We intend to verify the adequacy of that corrective action and other corrective actions at a future inspection.
 
4.    Your batch production records (BPRs) do not contain all of the information required by 21 CFR 111.260. Specifically, your batch production records for your "The Medicine Man's Ginkgo Biloba" (b)(4), "The Medicine Man's Complete Nutrients for Liver" (b)(4), and "Natural Solutions Manganese Plus" (b)(4) do not include the following information required by 21 CFR 111.260:
 
a.    The date and time of maintenance, cleaning, and sanitizing of equipment and processing lines used in producing the batch, or cross-reference to records, as required by 21 CFR 111.260(c);
 
b.    The weight or measure of each component used as required by 21 CFR 111.260(e);
 
c.    Statements of actual yield and percentage of theoretical yields at appropriate phases of processing, as required by 21 CFR 111.260(f);
 
d.    Documentation that the finished dietary supplement meets specifications established in accordance with § 111.70(e) and (g), as required by 21 CFR 111.260(i); and
 
e.    Documentation at the time of performance that quality personnel approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaging or relabeled dietary supplement, as required by 21 CFR 111.260(1)(4).
 
Based on the information you provided in your response dated June 16, 2015, we are not able to assess the adequacy of your corrective action to your BPRs and disposition of product related to the BPRs that failed to meet BPR requirements. We intend to verify the adequacy of that corrective action and other corrective actions at a future inspection.
 
5.    You failed to use effective measures to protect against the inclusion of metal or other foreign material in components or dietary supplements, such as filters or strainers; traps; magnets, or electronic metal detectors, as required by 21 CFR 111.365(i).
 
Specifically, your firm uses (b)(4) to combine and mix dry raw ingredients, a (b)(4), and a (b)(4) to manufacture your dietary supplements. However, there are no measures used by your firm to ensure metal fragments have not been introduced into the product after the use of this equipment where metal contamination is reasonably likely to occur.
 
Based on the information you provided in your response dated June 16, 2015, we are not able to assess the adequacy of your corrective action to use effective measures to protect against the inclusion of metal or other foreign material in components or dietary supplements. Although you indicate in your response that you are "in the process of researching which in-line metal detector would be best for [your] operation" and that you "hope to have this capability in place by next inspection," you did not provide documentation of a means to protect your products against metal contamination in the intervening time period. We intend to verify the adequacy of that corrective action and other corrective actions at a future inspection.
 
MISBRANDED DIETARY SUPPLEMENTS
 
Even if your "Natural Solutions Manganese Plus" product was not an unapproved new drug, it would still be a misbranded dietary supplement under section 403 of the Act [21 U.S.C. § 343] because the product does not comply with the labeling requirements for dietary supplements. Further, your "The Medicine Man's Complete Nutrients for Liver," "The Medicine Man's Ginkgo Biloba," and "The Medicine Man's Olive Leaf Extract" products are also misbranded dietary supplements for the reason discussed above. The inspection revealed the following violations of labeling requirements for dietary supplements:
 
1.    Your "The Medicine Man's Complete Nutrients for Liver," "The Medicine Man's Ginkgo Biloba," "Natural Solutions Manganese Plus," and "The Medicine Man's Olive Leaf Extract" products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are contained in capsules, but the capsule ingredients are not listed on the labels, as required by 21 CFR 101.4(g).
 
2.    Your "The Medicine Man's Complete Nutrients for Liver," "The Medicine Man's Ginkgo Biloba," and "The Medicine Man's Olive Leaf Extract" products are misbranded within the meaning of section 403(q)(1)(A) ofthe Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the labels are incorrect. The terms "serving" or "serving size" for a dietary supplement are defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2, as the maximum amount recommended on the label for consumption per eating occasion. For example,
 
• The directions of use for "The Medicine Man's Complete Nutrients for Liver" product suggest the consumer "Take 1 capsule twice a day with meals," but the serving size lists "2 capsules." The serving size listed should be one capsule.
 
• The directions of use for "The Medicine Man's Ginkgo Biloba" product suggest the consumer "Take 1 capsule 2 to 3 times a day," but the serving size lists "3 capsules." The serving size listed should be one capsule.
 
• The directions of use for "The Medicine Man's Olive Leaf Extract" product suggest the consumer "Take 1 capsule 1 to 3 times a day, between meals" but the serving size lists "3 capsules." The serving size listed should be one capsule.
 
3.    Your "The Medicine Man's Complete Nutrients for Liver" 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 of your product does not comply with 21 CFR 101.36. For example, the label lists the nutrient Selenium, which is a dietary ingredient that has a Reference Daily Intake (RDI) [also referred to as "(b)(2)-dietary ingredients"] as established in 21 CFR 101.9(c). However, it is declared in the incorrect order on the Supplement Facts label. In accordance with 21 CFR 101.36(b)(3)(i), dietary ingredients for which FDA has not established RDI's or DRY's must be presented in a column that is under the column for (b)(2) ingredients
 
Additionally, the label of your product does not list the correct nomenclature for selenium, as required by 21 CFR 101.36(d). "Selenium picolinate" should be listed as selenium (as selenium picolinate).
 
4.    Your "The Medicine Man's Complete Nutrients for Liver" product is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)], in that the label fails to identify the part of the plant from which the botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 21 CFR 101.36(d)(1). For example, the product label fails to include the part of the plant from which the following ingredients are derived (as per your spelling): Reishi Mushroom, Shitake Mushroom, Maitake Mushroom, Schishandra, Poria Cocos Mushroom, Hericium Mushroom, Cordyceps Sinesis Mushroom, and Milk Thistle.
 
This letter is not intended to be an all-inclusive list of the violations that may exist at your facility or in connection with the products that your manufacture and distribute. It is your responsibility to ensure the products you manufacture and distribute are in compliance with all requirements of the Act and applicable FDA regulations.
 
You should take prompt action to correct all of the violations noted in this letter and establish and implement procedures that will prevent these and other violations in the future. Failure to implement lasting corrective actions may result in FDA taking regulatory action, such as seizure or injunction, without further notice.
 
In addition to the above violations, we further note the following:
 
• Your "The Medicine Man's Complete Nutrients for Liver" product indicates some ingredients (e.g., Licorice Root Extract (5%), Reishi Mushroom (12.5%)) are standardized to a particular constituent or class of constituents (e.g., glycyrrhizin, polysaccharides) but the specific constituent(s) are not included on your label.
 
• There are ingredients, such as "Schishandra", Shitake Mushroom and Cordyceps Sinesis Mushroom that are incorrectly spelled on "The Medicine Man's Complete Nutrients for Liver" label.
 
• Your "The Medicine Man's Complete Nutrients for Liver," "The Medicine Man's Ginkgo Biloba," and "The Medicine Man's Olive Leaf Extract" products fail to list the name and place of business of the manufacturer, packer or distributor in accordance with 21 CFR 101.5. Specifically, your "The Medicine Man's Complete Nutrients for Liver," "The Medicine Man's Ginkgo Biloba," and "The Medicine Man's Olive Leaf Extract" product labels are lacking the complete street address. The street address may be omitted if it is shown in a current city directory or telephone directory.
 
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 determining 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.
 
Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the steps you have taken or will take to correct the above noted violations and prevent their recurrence. In your response, please include the timeframe in which the corrections will be completed and provide any documentation that will effectively assist us in evaluating whether the corrective actions have been made and the adequacy of such. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the time within which you will complete the corrections.
 
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Janice L. King, Compliance Officer, at the address noted in the letterhead. If you have questions, please contact Mrs. King at 843-746-2990, x16 or write her at the noted address.
 
Sincerely,
/S/
Ingnd A. Zambrana
District Director
Atlanta District Office