Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm529991.htm
Timestamp: 2019-04-21 15:09:21+00:00

Document:
The United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 704 West Meeker Street, Kent, Washington, on March 24, 25, and 29, 2016, and April 5 and 15, 2016. During the inspection we collected labeling for your products. Based on our inspection and subsequent review of your firm’s labeling, we found serious violations of the Federal Food, Drug and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.
The FDA reviewed your website at the Internet address www.biomedbalance.com in November 2016 and determined that you take orders there for the products Chaga, Eye Health, Hepatocel Plus, Reishi, Coriolus, Healthy Joint, Horny Goat Weed, and GlucoResistance. In addition, the FDA reviewed some of your product labels and your “BioMed Balance Beauty Naturally A Division of NutriResearch Inc pamphlet” that you include in product shipments to customers. The claims on your product labels and website and in your pamphlet establish that these products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 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.
The products listed above 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 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. §§ 321(d) and 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Your products Chaga, Eye Health, Hepatocel Plus, Reishi, Coriolus, Horny Goat Weed, GlucoResistance, and Healthy Vision 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, Chaga, Eye Health, Hepatocel Plus, Reishi, Coriolus, Horny Goat Weed, GlucoResistance, and Healthy Vision fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
Our investigators observed the following significant violations of FDA’s Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111), which render your Cordyceps Sinensis and Red Cordyceps Extract products adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)]. Additionally, even if your Healthy Vision product did not have therapeutic claims which make it an unapproved new drug and misbranded drug, Healthy Vision would be an adulterated dietary supplement under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] for the reasons described below.
The following observations were noted on the Form FDA 483, Inspectional Observations, issued to you on April 15, 2016. We received your response dated April 25, 2016, and have addressed relevant information from your response below.
You failed to establish and follow written procedures to fulfill the requirements relating to product complaints, as required by 21 CFR 111.553. Specifically, your firm has not established written procedures for the review and investigation of product complaints. Once you establish the required written procedures relating to product complaints, 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).
We have reviewed your response letter dated April 25, 2016, and find your response to be inadequate because the written procedure you provided fails to establish written procedures that fulfill the requirements applicable to the review and investigation of product complaints. Specifically, your written procedure fails to designate a qualified person to review all product complaints to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications, and your procedure does not require that quality control personnel must review and approve decisions about whether to investigate a product complaint, in accordance with 21 CFR 111.560.
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 [21 CFR 111.70(b)(3)].
b. You failed to establish in-process specifications for any point, step, or stage in the MMR where control is necessary to help 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 (label specifications) and for packaging that may come in contact with dietary supplements (packaging specifications), as required by 21 CFR 111.70(d).
d. You failed to 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 the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e).
Once you have established the required specifications, you must verify that the specifications are met, in accordance with 21 CFR 111.73.
We have reviewed your response letter dated April 25, 2016. We are unable to evaluate the adequacy of your corrective action because you failed to provide specific information to demonstrate that you have established the required specifications, as identified in 21 CFR 111.70.
f. Written instructions of 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 MMR [21 CFR 111.210(h)(1)].
4. You failed to prepare a batch production record (BPR) every time you manufactured a batch of dietary supplement, as required by 21 CFR 111.255(a). Specifically, you do not prepare a BPR as part of your production process.
We have reviewed your response letter dated April 25, 2016, but we are unable to evaluate the adequacy of your corrective action. In your response you provided a document titled Exhibit A for the purpose of demonstrating the MMR you intend to use to comply with MMR requirements, and your response asserts that the same document will be used “to comply the batch production record every time we manufactured a batch of dietary supplement.”However, the document provided does not include all information required as part of a BPR. Example of some of the missing information includes the identity of equipment and processing lines used in producing the batch; the date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in the production of the batch; the unique identifier that you assign to each component; and the identity and weight or measure of each components used (21 CFR 111.260).
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 a disposition decision, and for approving or rejecting any processing, as required by 21 CFR 111.103. Specifically, you have not established any quality control procedures.
Once you have established your written quality control procedures, you must implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.65.
We have reviewed your response letter dated April 25, 2016, but we are unable to evaluate the adequacy of your corrective action. Your response asserts that you have established written procedures for quality control to meet the identity, purity, strength, and composition of the finished products, but the documentation you provided with your response does not include written procedures for quality control operations that include actions for conducting a material review, making a disposition decision, and approving or rejecting any reprocessing.
You failed to establish and follow written procedures for returned dietary supplements, as required by 21 CFR 111.503. Specifically, you do not have written procedures for returned dietary supplements. During our inspection, our investigators observed returned products that were held in a small room at the back of your processing facility. These dietary supplements were not clearly identified as returned products and were not held or tagged to preclude redistribution. The investigators observed one box containing 36 bottles of unlabeled dietary supplements, along with returned boxes of dietary supplements with 2018 and 2019 expiration dates.
We have reviewed your response letter dated April 25, 2016, but we are unable to evaluate the adequacy of your corrective action. Your response states that you have established written procedures for certain situations in which dietary supplements are returned, but your response does not provide written procedures establishing the storage, tracking, and disposition of returned product. In addition, you did not advise what, if anything, you have done with the returned products our investigators observed during the inspection.
You failed to establish and follow written procedures for fulfilling the requirement for equipment and utensils, including written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.25(a). Specifically, you have not established a written accuracy check or calibration procedure for your floor and desktop scales.
We have reviewed your response letter dated April 25, 2016, but we are unable to evaluate the adequacy of your corrective action. Your response stated that you have established written procedures for calibrating floor and desktop weighing scales, but you provided no documentation to demonstrate whether and how such procedures have been established.
You failed to use equipment and utensils that are of appropriate design, construction, and workmanship to ensure them to be suitable for their intended use and to be adequately cleaned and properly maintained, as required by 21 CFR 111.27(a). Specifically, we observed white labels covering various holes of the capsule counting machine. These labels are moved depending on the desired number of capsules per bottle and appear to leave a residue behind after they are removed. We observed this machine being utilized in counting “Healthy Vision” capsules on March 24 and 25, 2016, prior to bottling.
You failed to establish and follow written procedures for packaging and labeling operations, as required by 21 CFR 111.403. Specifically, you have not established written procedures for labeling operations, and the labeling operations observed during the inspection identified significant discrepancies between your formula worksheet and the product label for your Healthy Vision, Cordyceps Sinensis, and Red Cordyceps Extract.
Once you have established the required procedures, you must establish, before packaging and labeling, packaging and labels for each batch of dietary supplement to determine whether the packaging and labels conform to the MMR, as required by 21 CFR 111.410(c).
Additionally, even if your Healthy Vision product did not have therapeutic claims which make it an unapproved new drug and misbranded drug, the product would be adulterated under section 402(c) of the Act [21 U.S.C. § 342(c)] because the product bears or contains color additives which are unsafe within the meaning of section 721(a) of the Act [21 U.S.C. § 379(a)]. Subject to limited exceptions, section 721(a) deems a color additive to be unsafe unless its use is in conformity with the color additive's listing regulation. Specifically, your Healthy Vision product declares Astaxanthin and Anthocyanins on the product label, which are not approved for use as color additives as they are used in this product.
Your Healthy Vision, Cordyceps Sinensis, and Red Cordyceps Extract products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the labels fail to list the name and place of business of the manufacturer, packer, or distributor. Specifically, the statement of the place of business fails to include the city for the Red Cordyceps Extract product and the zip code for all three products, in accordance with 21 CFR 101.5(d).
a. Your Healthy Vision product label fails to include the part of the plant from which Sabucus Nigra Extract is derived.
b. Your Cordyceps Sinensis and Red Cordyceps Extract product labels fail to include the part of the plant from which the cordyceps sinensis extract is derived.
a. The Cordyceps Sinensis and Red Cordyceps Extract product labels declare “Polysaccharide” and “Polysaccharides”, respectively, but fail to list the name of the individual Polysaccharide(s).
b. The Red Cordyceps Extract product label declares “S.B. Extract” but fails to list the common or usual name of this ingredient.
c. The Cordyceps Sinensis and Health Vision product labels indicate vegetarian capsules. However, the labels fail to declare the capsule ingredients.
4. Your Red Cordyceps Extract product is misbranded within the meaning of sections 403(s)(2)(A)(ii)(I) and 403(q)(5)(F) of the Act [21 U.S.C. §§ 343 (s)(2)(A)(ii)(I) and 343(q)(5)(F)] in that it fails to include the quantitative amount by weight per serving size of all the dietary ingredients as required by 21 CFR 101.36. Specifically, the product label fails to include the quantitative amount by weight of Standardized Polysaccharides; as noted previously, this ingredient must be listed by the common or usual name. We also note that if the “Standardized Polysaccharides” constituents of the Cordyceps Sinensis Extract product, then the common or usual name of the “Standardized Polysaccharides” should be indented under “Cordyceps Sinensis Extract” with the quantitative amount per serving.
Your Healthy Vision product is misbranded within the meaning of section 403(q)(5)(F) of the Act [U.S.C. § 343(q)(5)(F)] in that the label fails to declare Vitamin C in accordance with 21 CFR 101.36(c)(1). This dietary ingredient contained in the proprietary blend must be declared in accordance with 21 CFR 101.36(b)(2) and dietary ingredients contained in the proprietary blend that are listed under 21 CFR 101.36(b)(3) are to be indented under the term “Proprietary Blend” and listed under the column of names described in 21 CFR 101.36(b)(2)(i)(B).
Your Healthy Vision and Cordyceps Sinensis products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the labels do not include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).
Your Red Cordyceps Extract dietary supplement 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 include a domestic address or domestic phone number through which the responsible person, as described in section 761(b) of the Act [21 U.S.C §379AA-1], 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 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.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations and implement lasting corrective action of these violations may result in regulatory action without further notice, including, without limitation, seizure and injunction.
1. Any expiration date, shelf life, or “Best by” date you place on a product label should be supported by stability data [72 Fed. Reg. 34752, 34856 (Jun. 25, 2007)]. The term “shelf life dating” includes expiration dating and “best if used by” dating [72 Fed. Reg. 34752, 34912 (Jun. 25, 2007)]. You informed our investigator that you use expiration dates on your finished product labels; however, you did not have stability testing data to support this date.
2. Records must be maintained that demonstrate that products are not manufactured from, processed with, or does not otherwise contain prohibited cattle materials [21 CFR 189.5(c)(1)]. During the inspection your firm stated that the soft gel caps used for herbal oil products are derived from bovine products or by-products; however, your firm was not able to provide any documentation to support the materials are free from bovine spongiform encephalopathy (BSE). Your firm also stated you do not have any established specifications for animal-derived ingredients to ensure they are BSE free.
Please notify this office in writing within fifteen 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, or other similar violations, from occurring again. You should include documentation of corrective actions you have taken to date. If your firm’s planned corrections will occur over time, please state the reason for the delay and include a timetable for implementation of those corrections.
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 reply should be sent to: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Patricia A. Pinkerton, Compliance Officer. Refer to the identification number WL SEA 17-02 when replying. If you have any questions regarding any issues in this letter, please contact Compliance Officer Patricia Pinkerton by telephone at 425-302-0428.

References: § 321
 § 321
 § 352
 § 331
 § 342
 § 342
 § 342
 § 379
 § 343
 § 343
 § 343
 § 343
 §379