Warner Herb Co. MARCS-CMS 586299 — February 21, 2020

WARNING LETTER

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• Delivery Method: United Parcel Service
• Product: Drugs

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• Recipient: John E. Warner; Owner; Warner Herb Co.; 7365 Highway 127 South; Crossville, TN 38572; United States

• Issuing Office: Office of Human and Animal Foods Operations-East; United States

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February 21, 2020

WARNING LETTER 586299

Dear Mr. Warner:

On May 20-23, 2019, investigators with the U.S. Food and Drug Administration (FDA) inspected your facility located at 7365 Highway 127 South, Crossville, Tennessee. Based on the inspectional findings, a subsequent review of your product labeling, including your “Medicinal Catalog,” collected during the inspection and your website at www.warnerherbs.com, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA’s website at www.fda.gov.

Unapproved New Drugs/Misbranded Drugs

FDA reviewed your “Medicinal Catalog” and website at the Internet address www.warnerherbs.com in January 2020 and has determined that you take orders there for the products AZ, C, DB, Devil’s Claw Root, Ginkgo Leaf, G-K-S, HB, P, P-SITES, TC, AL, AS, BRONC, CHO, ENDO, F, HY, PL, and PN. The claims on your website establish that the products are drugs under section 201(g)(1)(B) of the Act [21 United States Code (UCS) § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.

Examples of some of the claims, including claims about ingredients present in these products, that provide evidence that your products are intended for use as drugs include:

AZ:
• “ALZHEIMER’S”
“Echinacea Angustifolia Root, Pau D’Arco Bark, Gota Kola Herb, Spirulina Plant, Wild American Ginseng Root and Gingko Leaf.”
• Echinacea – (Angustifolia Root):
    o “[B]lood poisoning. . . eczema . . . peritonitis, infections. . . natural antibiotic, gargle for sore throat, colds.”
• Gota Kola Herb:
    o “[H]igh blood pressure”
• Spirulina Plant:
    o “[B]alances blood sugar. . .”
• Ginkgo Leaf:
    o “[R]educe clotting of blood. . .”

C:
• “CANCER”
“Sheep Sorrel Herb, Burdock Root, Slippery Elm Bark, Goldenseal Root, St. Johnswort (sic) Herb, Garlic Bulb, Red Root, Poke Root, Ginkgo Leaf, Red Clover Blooms, Chickweed herb.”
• Sheep Sorrel Herb:
    o “Cancer, diarrhea. . .inflammations, fevers. . .antiseptic. . . . Its [sic] the best anticancer herb of them all.”
• Red Root:
    o “Diabetes, asthma, chronic bronchitis. . . dysentery, whooping cough, tuberculosis, cancer.”
• Red Clover Blossoms:
   o “Syphilis. . . pellagra, leprosy, cancerous growths, cancer. . .”
• St. Johns Wort Herb:
   o “Anemia. . .diarrhea. . . jaundice. . . cancer, aids, excellent anti-depressant, depression.”
• Ginkgo Leaf:
   o “[R]educe clotting of blood. . .”

DB:
• “DIABETES”
“Blue Chohosh Root, Goldenseal root, Dandelion Root, , Star Grub Root, Queen of the Meadow Root, Uva Ursi Herb, Fenugreek Seed, Wild Sarsaparilla Root.”
• Blue Cohosh Root:
    o “[H]igh blood pressure, diabetes. . .”
• Dandelion Root:
    o [A]nemia. . . diabetes. . . low blood pressure. . .”
• Golden Seal (sic) Root:
    o “[N]eutratlizes poisons, all stomach disorders. . .diabetes, natural antibiotic.”

Devil’s Claw Root:
• “Arthritis”

Ginkgo Leaf:
• “[R]educe clotting of blood. . .”

G-K-S:
“Ginkgo Leaf, Kava Kava Root, and St. Johnswort (sic) herb”
• Ginkgo Leaf:
    o “[R]educe clotting of blood. . .”
• Kava Kava Root:
    o “Anti depressant. . . migraines. . . antipasmodic (sic).”
• St. Johns Wort Herb:
    o “Anemia. . .diarrhea. . . jaundice. . . cancer, aids, excellent anti-depressant, depression. . .”

HB:
• “HIGH BLOOD PRESSURE”
“Capsicum Fruit, Black Cohosh Root, Garlic Bulb, Gingko Leaf, Wild Cherry Bark, Goldenseal Root, True Blue Skullcap Herb, Turkey Rhubarb Root, Hawthorn Berries.”
• Capsicum Fruit (Cayenne)
    o “[R]heumatism, inflammations, pleurisy, antispasmodic. . . ulcerated stomach, yellow fever, all fevers.”
• Black Cohosh Root:
    o “[A]sthma, high blood pressure. . .”
• Garlic Bulb:
    o “[H]igh blood pressure, arteriosclerosis, natural antibiotic, yeast infections, parasites. . . fever, contagious disease, cancer, diarrhea.”
• Ginkgo Leaf:
    o “[R]educe clotting of blood. . .”
• Wild Cherry Bark:
    o “Coughs, colds, measles. . . fever, intestinal worms. . . tuberculosis.”
• Golden Seal (sic) Root:
    o “[N]eutratlizes poisons, all stomach disorders. . .diabetes, natural antibiotic.”
• True Blue Skullcap Herb:
    o “[N]euralgia aches and pains. . . shaking palsy. . .epilepsy. . .”
• Turkey Rhubarb Root:
    o “Contagious disease. . . constipation. . .”
• Hawthorn Berries:
    o “[H]ighblood (sic) pressure. . . rheumatism, arthritis, arteriosclerosis.”

P:
• “PAIN”

P-SITES:
• “PARASITES”

TC:
• “TUBERCULOSIS”
“Myrrh Gum, Skunk Cabbage Root, Wild Cherry Bark, Goldenseal Root, Burdock Root, Yellow Dock Root, Plantain Root, Slippery Elm Bark, and Wild Ginger Root.”
• Skunk Cabbage Root:
    o “Tuberculosis, chronic catarrh. . .pleurisy, epilepsy. . .”
• Myrrh Gum Bark:
    o “Excellent for pyorrhea, bronchial and lung diseases,. . . ulcers. . . gangrene. . . asthma, tuberculosis, ulcerated throat.”
• Wild Cherry Bark:
    o “Coughs, colds, measles. . . fever, intestinal worms. . . tuberculosis.”
• Golden Seal (sic) Root:
    o “[N]eutratlizes poisons, all stomach disorders. . .diabetes, natural antibiotic.”
• Yellow Dock Root:
    o “[A]nemia, acne. . .tumors, psoriasis. . .”
• Plaintain (sic) Root:
    o “Diarrhea. . .hemorrhage. . .tumors, ulcers. . .”
• Wild Ginger Root”
    o “[B]ronchitis. . .”

AL:
• “ALLERGIES”

AS:
• “ASTHMA”

BRONC
• “BRONCHITIS”

CHO
• “HIGH CHOLESTEROL”

ENDO
• “ENDOMETRIOSIS”

F
• “FLU”

HY
• “HYPOGLYCEMIA”

PL
• “PLEURISY”

PN
• “PNEUMONIA”

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 USC § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 USC §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 USC § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 USC § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your products AZ, C, DB, G-K-S, HB, TC, BRONC, CHO, ENDO, and PN are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your AZ, C, DB, G-K-S, HB, TC, BRONC, CHO, ENDO, and PN products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 USC § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 USC § 331(a)].

Adulterated Dietary Supplements

During the May 20-23, 2019 inspection of your facility, our investigators observed the following significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR 111). These violations render your dietary supplement products adulterated under section 402(g)(1) of the Act [21 (USC) § 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet the CGMP requirements for dietary supplements. Additionally, even if your AZ, C, DB, Devil’s Claw Root, Ginkgo Leaf, G-K-S, HB, P, P-SITES, TC, AL, AS, BRONC, CHO, ENDO, F, HY, PL, and PN products did not have therapeutic claims that make them unapproved new drugs and misbranded drugs, these products would be adulterated dietary supplements within the meaning of section 402(g)(1) of the Act because the products have been prepared, packed, or held under conditions that do not meet the CGMP requirements for dietary supplements.

We acknowledge receipt of your undated written response to the Form FDA 483, Inspectional Observations, issued to you on May 23, 2019. We address your response below in relation to each of the relevant violations.

The significant violations documented during the inspection include, but are not limited to, the following:

1. You did not perform manufacturing operations under conditions and controls that protect against the potential for contamination, as required by 21 CFR 111.365(a). For example, during the inspection our investigator observed:

a. On May 21, 2019, an employee bottling your B-CL dietary supplement (bottle Lot (b)(4)) in the (b)(4) Area traveled to the (b)(4) Area to (b)(4). The bottling employee (b)(4). The bottling employee then filled additional capsules with your B-CL dietary supplement (from bulk powder Lot (b)(4)) before leaving the (b)(4) Area and returning to the (b)(4) Area.

b. On May 21, 2019, an employee bottled your Saw Palmetto (bottle Lot (b)(4)), GKS (bottle Lot (b)(4)), and B-CL lot (bottle Lot (b)(4)) dietary supplements in the (b)(4) Area. The employee did not perform cleaning operations of the (b)(4) between these product runs.

We acknowledge receipt of your undated written response to the Form FDA 483, Inspectional Observations, issued to you on May 23, 2019. Your response indicates that employees were informed of certain actions to avoid contamination. However, we are unable to evaluate the adequacy of your response because your response does not provide documentation to demonstrate that you are performing manufacturing operations under conditions and controls that protect against the potential for contamination.

2. You did not establish product specifications 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 dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, you indicated that you have not established finished product specifications for the identity, purity, strength, and composition, and for limits on contamination that may adulterate, or that may lead to adulteration of the finished batch of dietary supplement. Additionally, our investigator observed that you have not established finished product specifications for your dietary supplement products including, but not limited to, B-CL, Gingko Leaf, P-SITES, PRO, and GKS, that you manufactured, packaged, labeled, and/or distributed.

We acknowledge receipt of your undated written response to the Form FDA 483, Inspectional Observations, issued to you on May 23, 2019. Your response indicates that employees were instructed “(b)(4)” and to take certain actions to reduce the possibility of cross contamination. However, we are unable to evaluate the adequacy of your response because your response does not address or demonstrate that you have established product specifications for the finished batch of dietary supplements you manufacture, as noted above.

3. You did not establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplement, including specifications to ensure that you used the specified packaging and that you applied the specified label, as required by 21 CFR 111.70(g). Specifically, you have not established packing and labeling specifications for your finished dietary supplement products, including, but not limited to, your Saw Palmetto, GKS, and B-CL products.

We acknowledge receipt of your undated written response to the Form FDA 483, Inspectional Observations, issued to you on May 23, 2019. Your response indicates that you are implementing a label inventory log and providing “(b)(4)” as corrective actions. However, we are unable to evaluate the adequacy of your response because your response does not address or demonstrate that you have established specifications for the packaging and labeling of the finished dietary supplements you manufacture, as noted above.

4. You did not establish component specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b). Specifically, you failed to establish the following component specifications:

a. Identity specification [21 CFR 111.70(b)(1)];
b. Component specifications, for each component that you use in the manufacture of a dietary supplement, that are necessary to ensure that specifications for the purity, strength, and composition of the dietary supplements manufactured using the components are met [21 CFR 111.70(b)(2)]; and
c. Specifications that establish the limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement [21 CFR 111.70(b)(3)].

Before using a component, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, as required by 21 CFR 111.75(a)(1)(i), unless you petition the agency under 21 CFR 111.75(a)(1)(ii) and the agency exempts you from such testing. You must also confirm the identity of other components and determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met, as required by 21 CFR 111.75(a)(2).

5. You did not establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103 and 21 CFR 111.140(b)(1). Specifically, our investigator observed that you do not have written procedures for responsibilities of the quality control operations, and you do not perform or document any of the required quality control operations for the processes you perform, such as material review and disposition decisions.

Once you have established your quality control written procedures, you must implement quality control operations in your manufacturing, packaging, labeling, and holding operations, as required by 21 CFR 111.65, and you must implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in a master manufacturing record, as required by 21 CFR 111.55. Quality control personnel must ensure that your manufacturing, packaging, labeling, and holding operations 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 111.105. Furthermore, you must have documentation, at the time of performance, of the quality control personnel review and approval for release, or rejection, of any packaged and labeled dietary supplement for distribution, as required by 21 CFR 111.127(h) and 111.140(b)(2).

We acknowledge receipt of your undated written response to the Form FDA 483, Inspectional Observations, issued to you on May 23, 2019. In your response, you indicate that you are in the process of developing such written procedures. However, we are unable to evaluate the adequacy of your response because you did not provide documentation to demonstrate that you have established such written procedures.

6. You did not prepare and follow a written master manufacturing record for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, your employee indicated that the firm does not have master manufacturing records for any of your dietary supplements.

We acknowledge receipt of your undated written response to the Form FDA 483, Inspectional Observations, issued to you on May 23, 2019. In your response, you indicate that you are in the process of developing master manufacturing records. However, we are unable to evaluate the adequacy of your response because you did not provide any documentation demonstrating that you have established such records.

7. You did not prepare a batch production record every time you manufactured a batch of dietary supplement, as required by 21 CFR 111.255(a). Specifically, your employee indicated that the firm does not have batch production records for any of your dietary supplements.

We acknowledge receipt of your undated written response to the Form FDA 483, Inspectional Observations, issued to you on May 23, 2019. In your response, you state that you are in the process of developing a “batch product log.” However, we are unable to evaluate the adequacy of your response because you did not provide any documentation demonstrating that you are preparing batch production records every time you manufacture a batch.

8. You did not establish written procedures for your packaging and labeling operations, as required by 21 CFR 111.403. Specifically, you do not have written procedures for your packaging and labeling operations. Such procedures must satisfy the requirements that apply to packaging and labels as specified in 21 CFR 111.410, including controlling the issuance and use of packaging and labels and reconciliation of any issuance and use discrepancies [21 CFR 111.410(b)]. We note that our investigator observed that you did not conduct label reconciliation of any issuance and use discrepancies for labels issued and used during labeling operations on May 21, 2019 for GKS (bottle Lot (b)(4)), and B-CL (bottle Lot (b)(4)).

We acknowledge receipt of your undated written response to the Form FDA 483, Inspectional Observations, issued to you on May 23, 2019. In your response, you state that “(b)(4)” and will be maintaining a log of outgoing and incoming labels “(b)(4).” However, we are unable to evaluate the adequacy of your response because you did not provide any documentation demonstrating that you have established such written procedures.

9. You did not collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). Specifically, you did not collect and hold reserve samples for the finished dietary supplement products that you distribute.

We acknowledge receipt of your undated written response to the Form FDA 483, Inspectional Observations, issued to you on May 23, 2019. In your response, you state that you are now maintaining reserve samples. However, we are unable to evaluate the adequacy of your response because you did not provide any documentation demonstrating that you are collecting and holding reserve samples.

10. You did not identify each unique lot within each unique shipment of components that you receive and any lot of components that you produce in a manner that allows you to trace the lot to the supplier, the date received, the name of the component, the status of the component (e.g., quarantined, approved, or rejected); and to the dietary supplement that you manufactured and distributed, as required by 21 CFR 111.155(d)(1). Specifically, you do not identify each unique lot within each unique shipment in a manner that allows you to trace the components you receive and/or produce. For example, during the inspection our investigator observed that:

a. approximately 28 of (b)(4) entries reviewed from your Receiving Log notepad for components received at your firm did not identify the supplier.
b. none of the approximately (b)(4) entries reviewed from your Receiving Log notepad for components received at your firm contained the date the components were received at your firm.
c. none of the approximately (b)(4) entries reviewed from your Receiving Log notepad for components received at your firm contained the status of the components (e.g., approved, quarantined, or rejected).
d. numerous different components received at your firm were noted to have been assigned the same internal lot number of the approximately (b)(4) entries reviewed from your Receiving Log notepad for components received at your firm.

We acknowledge receipt of your undated written response to the Form FDA 483, Inspectional Observations, issued to you on May 23, 2019. In your response, you state that you are in the process of developing a receiving log. However, we are unable to evaluate the adequacy of your response because you did not provide any documentation demonstrating that you are identifying each unique lot in a manner that allows you to trace the components you receive and produce to the distributed dietary supplement.

11. You did not identify each unique lot within each unique shipment of packaging in a manner that allows you to trace the lot to the supplier, the date received, the name of the packaging, the status of the packaging (e.g., quarantined, approved, or rejected); and to the dietary supplement that you distributed, as required by 21 CFR 111.160(d)(1). Specifically, during the inspection our investigator observed that you do not identify or log any unique lot of packaging materials (e.g., bottles and caps) received at your firm and used in the packaging of your finished dietary supplements.

We acknowledge receipt of your undated written response to the Form FDA 483, Inspectional Observations, issued to you on May 23, 2019. In your response, you state that you are in the process of developing a receiving log. However, we are unable to evaluate the adequacy of your response. You did not provide any documentation demonstrating that you are identifying each unique lot in a manner that allows you to trace the packaging you receive to the supplier, the date received, the name of the packaging, and the status of the packaging; and to the distributed dietary supplement.

Misbranded Dietary Supplements

Certain of your dietary supplement products, as discussed below, are misbranded within the meaning of section 403 of the Act [21 USC § 343] because they do not comply with the labeling requirements for dietary supplements as required by 21 CFR 101. Additionally, even if your AZ, C, DB, Devil’s Claw Root, Ginkgo Leaf, G-K-S, HB, P, P-SITES, and TC products are dietary supplements and/or were not unapproved new drugs/misbranded drugs, they would be misbranded within the meaning of section 403 of the Act and/or in violation of the following provisions of 21 CFR 101.

1. Your Warner’s brand AZ, BL-C, BOW-C, C, DB, Devil’s Claw Root, Ginkgo Leaf, G-K-S, HB, K, L, NA, P, PRO, P-SITES, TC, TEST-B, and Turmeric Root products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 USC § 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. Specifically:

a. The standardized common name of a botanical dietary ingredient as noted in Herbs of Commerce must be used in the Supplement Facts label, per 21 CFR 101.36(d) and 101.4(h). If no standardized common name exists, then the Latin binomial name must be indicated. For example, on your AZ product, you list Echinacea Angustifolia. This is the Latin binomial name. However, the Herbs of Commerce lists three common or usual names. One of these names should be listed rather than the Latin binomial name.
b. The term “star grub” in the Warner’s brand DB product does not appear to be a standardized common name.
c. These product labels fail to present nutrition information on the nutrition label using the title supplement facts in accordance with 21 CFR 101.36(e).
d. These product labels fail to enclose the supplement facts information in a box separate from other labeling material with the headings, hairlines, bolding, etc. as required by 21 CFR 101.36(e).

2. Your Warner’s brand TC and NA products are misbranded within the meaning of sections 403(s)(2)(A)(ii)(I) and 403(q)(5)(F) of the Act [21 USC §§ 343 (s)(2)(A)(ii)(I) and 343(q)(5)(F)] in that their labels fail to include the quantitative amount by weight per serving size of all the dietary ingredients as required by 21 CFR 101.36.

3. Your Warner’s brand BL-C, BOW-C, C, DB, Devil’s Claw Root, Ginkgo Leaf, G-K-S, HB, K, L, P, PRO, P-SITES, TEST-B, and Turmeric Root products are misbranded within the meaning of section 403(i)(2) of the Act [21 USC § 343(i)(2)] in that it is fabricated from two or more ingredients, and each ingredient is not declared on the label by the common or usual name, in accordance with 21 CFR 101.4 and 21 CFR 101.36. Specifically, the ingredient list does not declare the capsule ingredient as an “other ingredient,” in accordance with 21 CFR 101.4(g). Further, the declaration of “gelatin capsules” does not include the ingredients comprising the capsules.

4. Your Warner’s brand BL-C, BOW-C, C, DB, Devil’s Claw Root, Ginkgo Leaf, G-K-S, HB, K, L, NA, P, PRO, P-SITES, TC, TEST-B, and Turmeric Root products are misbranded within the meaning of section 403(q)(1)(B) of the Act [21 USC § 343(q)(1)(B)] because the labels fail to list the servings per container under the serving size on the left hand side of the nutrition label or fails to include this information as part of the net quantity of contents declaration in accordance with 21 CFR 101.36(b)(1)(ii).

5. Your Warner’s brand BOW-C product is misbranded within the meaning of section 403(q)(1)(A) of the Act [21 USC § 343(q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Your Serving Size is listed as “2 capsules” and your Directions state to “Take 2-4 capsules in the morning, 2-4 capsules at night.” Therefore, the correct serving size should be 4 capsules.

6. Your Warner’s brand L, NA, P-SITES, B-CL, BOW-C, G-K-S, K, P, PRO, C, HB, and DB products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 USC § 343(s)(2)(C)] because the labels fail to identify, in English, the part of the plant (e.g. root, leaves, entire or whole plant) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). Likewise, “herb” does not identify the specific part of the plant.

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist 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 you comply will all requirements of federal law, including FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time in which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

Section 743 of the Act, 21 USC § 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 non-compliance 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 USC § 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.

Please send your reply to correspondence to the ORAHAFEAST5FirmResponses@fda.hhs.gov mailbox. Any questions you may have regarding this process should be directed to Compliance Officer Zada L. Giles at (615) 366-7985.

Sincerely,
/S/

Kimberly L. McMillan
Acting Director, Division V
Office of Human and Animal Foods Operations-East