Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm620697.htm
Timestamp: 2019-04-19 04:22:20+00:00

Document:
The U.S. Food and Drug Administration conducted an inspection of your facility, located at 4091 West 11th Avenue, Suite C, Eugene, Oregon, from March 26, 2018, through April 4, 2018. Based on the inspection and a review of the product labels, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You may find the Act and related regulations through links in FDA's home page at www.fda.gov.
We received a letter from you dated April 24, 2018, written in response to the Form FDA 483, Inspectional Observations, issued to you at the close of the inspection. We address your response below, in relation to each of the noted violations.
iii. 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, as required by 21 CFR 111.70(b)(3).
b. You failed to establish in-process production 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, and, as necessary, for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.70(c)(1).
c. You failed to establish specifications for dietary supplement labels (labeling specifications) and for packaging that may come in contact with dietary supplements, as required by 21 CFR 111.70(d).
d. 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 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).
We have reviewed your response dated April 24, 2018. You indicated you will establish component specification, in-process specifications, labeling specifications, packaging specifications, and finished product specifications by July-August 2018. We are unable to assess the adequacy of any corrective actions you have made for this violation because you have not provided documentation of the corrections.
Once you have established component specifications and before using a component, you must conduct at least one appropriate test or examination to verify the identity of the dietary ingredient prior to its use, as required by 21 CFR 111.75(a)(1)(i). Further, you must 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).
h. Written instructions for corrective action plans to use when a specification is not met [21 CFR 111.210(h)(5)].
We have reviewed your response dated April 24, 2018. You indicated that this would be corrected by June 2018. We are unable to assess the adequacy of any corrective actions you have made for this violation because you have not provided documentation that you have prepared and are following a written master manufacturing record for each formulation of dietary supplement that you manufacture.
3. Your batch production records (BPRs) did not include complete information relating to the production and control of each dietary supplement batch that you manufacture, and did not include all information required in a BPR, as required by 21 CFR 111.255(b) and 21 CFR 111.260.
We reviewed your response dated April 24, 2018, and determined it is inadequate. In your response you provided a template Batch Report (Rev. 2 4/5/18); however, it does not include complete information relating to the production and control for a specific batch of dietary supplement produced, as required by 21 CFR 111.255(b). For example, the batch report template did not include the identity of the equipment used in producing the batch; (b)(4) identifier that you assigned to each component; a statement of the actual yield; the results of any testing or examination performed during the batch production, or a cross-reference to such results; or documentation, at the time of performance, of packaging and labeling operations, actions taken by quality control personnel, any required material review and disposition decision, or any reprocessing, as required by 21 CFR 111.260.
We reviewed your response dated April 24, 2018. We are unable to evaluate your response due to lack of supporting documentation. Your response states that (b)(4); however, you did not provide how the equipment is being cleaned in the interim or documentation to support the new cleaning products you have ordered or how you have determined that these cleaning products are adequate and safe.
5. You failed to make and keep records for repackaging and relabeling operations, as required by 21 CFR 111.430(a). Specifically, during the inspection, you were unable to provide to our investigator documentation to support the re-bottling operation for Multi-Vitamin & Mineral Complex capsules, Lot 1708019.
6. You failed to establish and follow written procedures for the requirements related to product complaints, as required by 21 CFR 111.553. Specifically, during the inspection your firm provided our investigator with a standard operating procedure document titled, “Customer Complaint Procedure/Log.” However, this document does not provide how you fulfill the requirements of a review and investigation of a product complaint, in accordance with 21 CFR 111.560.
Additionally, you provided documentation of a complaint receivedfor Immune Boost 120 V-Caps 1710004 Exp. 11/20, but the document does not describe how you reviewed or investigated the product complaint. We note that you must make and keep a written record of every product complaint that is related to good manufacturing practice, in accordance with 21 CFR 111.570(b)(2).
1. Your Back to Health brand B-50 Complete, Multi-Standard/Multi Vitamin & Mineral Complex, Milk Thistle, and MSM-Glucosamine-Chondroitin products are misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the labels fail to include a statement of identity as a “dietary supplement,” as required by 21 CFR 101.3(a) and (g).
2. Your Back to Health brand Extra Strength Milk Thistle product is misbranded within the meaning of section 403(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. The “Suggested Usage” states, “Take 1-2 capsules daily with meals,” but the serving size lists “1 Capsule.” The serving size listed should be two capsules.
i. Incorrectly lists chromium, manganese and molybdenum as minerals with a “Daily Value not established.” Dietary ingredients with daily values must be listed in accordance with 21 CFR 101.36(b)(2)(iii). Daily Values are listed in 21 CFR 101.9(c)(8)(iv).
ii. The unit of measure is incorrectly listed for copper and manganese; the unit of measure should be milligrams and not micrograms, per 21 CFR 101.9(c)(8)(iv).
iii. Vanadium is incorrectly listed within the listing of (b)(2)-dietary ingredients. Vanadium is a (b)(3)-dietary ingredient and must be placed below the listing of (b)(2)-dietary ingredients, per 21 CFR 101.36(b)(3) and (e)(6)(ii).
iv. The product label incorrectly declares beta carotene. A statement of the percent of Vitamin A that is present as beta-carotene may be declared voluntarily in accordance with 21 CFR 101.36(b)(2)(i)(B)(3). When the vitamins and minerals are listed in a single column, the statement must be indented under the information on the Vitamin A, per 21 CFR 101.9(c)(8)(vi).
b. Your Back to Health brand B-50 Complete, Multi-Vitamin & Mineral Complex, and Iron Chelate Support products: Each product label lists (b)(2)-dietary ingredients in an incorrect order per 21 CFR 101.36(b)(2)(i)(B).
i. Each product label fails to bear a heavy bar below the last listed (b)(2)-dietary ingredient, per 21 CFR 101.36(e)(6)(ii).
ii. Each product label lists the term Vitamin B5 in the Supplement Facts label; this is not an authorized synonym for use in the Supplement Facts label.
i. The product label incorrectly lists the order of the dietary ingredients Vitamin B1, Vitamin B2, Vitamin B6 and Vitamin B12, in accordance with 21 CFR 101.9(c)(8)(v) and 101.36(b)(2)(i)(B).
ii. The product label fails to declare the common or usual names of each ingredient used, as required by 21 CFR 101.36(b)(3) and 21 CFR 101.4. Specifically, probiotic (188 Million CFU’s) is not the common or usual name of an ingredient.
e. Your Back to Health brand B-50 Complete and Iron Chelate Support products: The B-50 Complete product label fails to declare the source of the thiamine, niacin, and pyridoxine; likewise, the Iron Chelate Support product label fails to declare the source of the Vitamin B12. The source of a dietary ingredient must be declared per 21 CFR 101.36(d).
FDA reviewed your product labels collected during the inspection for Healing Salve, Human Growth Hormone, and Advanced DHEA. The claims on the labels establish that the products are drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or to affect the structure or function of the body.
Your Healing Salve, Human Growth Hormone, and Advanced DHEA products are not generally recognized as safe and effective for the above referenced uses and, therefore, they are “new drugs” under section 201(p) of the Act [21 U.S.C. § 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 U.S.C. §§ 331(d) and 355(a)].
FDA reviewed your product labels collected during the inspection for the companion animal products CranUTi and Horse Calm. The claims on the product labels establish that these products are intended for use in the cure, mitigation, treatment, or prevention of disease in animals, which makes them drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. Further, as discussed below, these products are unapproved new animal drugs and introducing or delivering these products for introduction into interstate commerce violates the Act.
Examples of some of the claims on your product labels that provide evidence that your products are intended for use as animal drugs are listed below.
In addition, the product name, CranUTi is an implied claim for treatment of urinary tract infection (UTI).
Because your CranUTI and Horse Calm products are intended to cure, mitigate, treat, or prevent disease in animals, they are drugs within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. Moreover, these products are new animal drugs, as defined by section 201(v) of the Act [21 U.S.C. § 321(v)], because they are not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. They are not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. Therefore, these products are unsafe within the meaning of section 512(a) of the Act [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)]. The introduction or delivery for introduction into interstate commerce of these adulterated drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
This letter is not intended to be an all-inclusive list of the 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 your firm complies with the Act and FDA regulations. We note that similar violations were observed on previous FDA inspections.
You should take prompt action to correct the violations cited in this letter. Failure to do so may result in regulatory action being initiated without further notice, including, without limitation, seizure and/or injunction.
Please notify this office in writing within fifteen (15) business days from the date you receive this letter describing the specific steps you have taken to correct the noted violations, and to prevent these violations from recurring or other similar violations from occurring. You should include documentation of corrective actions you have taken to date. 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 your firm will not be able to complete corrective actions before you respond, please state the reason for the delay and include a timetable for implementation of those corrections.
Your B-50 Complete and MSM-Glucosamine-Chondroitin product labels bear the FDA disclaimer statement, but the statement is not placed in accordance with 21 CFR 101.93(d). Specifically, the disclaimer statement is not placed adjacent to the structure/function claims without intervening material or linked to the claims with a symbol at the end of each such claim that refers to the same symbol placed adjacent to the disclaimer statement.
Your B-50 Complete product label includes intervening material in the Other Ingredient statement; “Bob’s Red Mill” is intervening material. Likewise, your Back to Health Multi-Vitamin & Mineral Complex product label contains intervening material, that is, the terms “VITAMINS” and “MINERALS.” All information appearing on the information panel of the product label should appear in one place without other intervening material in accordance with 21 CFR 101.36 and 21 CFR 101.2(e).
You state in SOP QS-006 Raw Material Receiving, “For organic material INC accepts the identity tests from the manufacturer. The organic status of the company and the material is checked against the FDA Organic Integrity Data Base and the certifying agency is noted.” FDA is not responsible for the Organic Integrity Database or regulate organic standards. The organic status of the company or component is not part of the identity testing required under 21 CFR 111.75(a). We note that under 21 CFR 111.75(a)(1)(i), you cannot rely on the identity test results from your supplier for dietary ingredients.
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 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 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Your firm’s response should be sent to: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Jessica L. Kocian, Compliance Officer. If you have any questions regarding this letter, please contact Compliance Officer Jessica Kocian at 425-302-0444.

References: § 343
 § 321
 § 321
 § 321
 § 321
 § 321
 § 360
 § 351
 § 331
 § 379
 § 379