Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm367832.htm
Timestamp: 2019-04-19 18:43:08+00:00

Document:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your firm, Y.S. Health Corp., located at 411 Kingston Court, Mt. Prospect, Illinois, from December 6, 2012 to January 30, 2013. The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, 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 (FD&C Act) [21 U.S.C. § 342(g)(1)], in that the dietary supplement products have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements.
Additionally, our investigator collected and reviewed labeling of your products. We also reviewed your website at www.yshealth.com in May 2013. Based on our review, we have concluded that certain of your products are unapproved and/or misbranded drugs in violation of Sections 403, 505(a), 502(c), and 502(f)(1) of the FD&C Act [21 U.S.C. §§ 343, 355(a), 352(c), and 352(f)(1)]. Introduction of these products into interstate commerce is prohibited under Section 301(d) and/or 301(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 331(a)]. You may find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.
We received a written response from you dated February 15, 2013 concerning our investigator’s observations noted on the Form FDA-483, Inspectional Observations, issued to you. FDA also acknowledges the receipt of your procedures and forms as corrections to the observations. We address each of these documents, in relation to each of the noted violations.
Drug products intended for topical (external) analgesic indications, such as the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains are covered under the Tentative Final Monograph (TFM) for OTC External Analgesics (48 FR 5852, February 8, 1983). However, Arth 2000+ Cream is not eligible for consideration under this TFM because its formulation includes “Kre-Celazine,” which is promoted by labeling statements as a patented formula having therapeutic value and therefore is considered an active ingredient under 21 CFR § 201.66(b)(2). While the labeled active ingredient, menthol, is included in the TFM, “Kre-Celazine” is not an active ingredient that is included in the OTC Drug Review for any indication. In addition, the labeled indications “rheumetoid (sic) arthritis,” “inflammation,” and “repairs damaged joints” are not addressed in the external analgesics TFM. We are not aware of any products with such a formulation and labeling as Arth 2000+ Cream existing in the U.S. marketplace at the inception of the OTC Drug Review or that has otherwise been determined through rulemaking as eligible for inclusion in that review. Furthermore, we are not aware of any evidence establishing that Arth 2000+ Cream, as formulated and labeled, is generally recognized as safe and effective as an OTC external analgesic drug product. Therefore, Arth 2000+ Cream is a new drug within the meaning of Section 201(p) of the FD&C Act [21 U.S.C. § 321(p)]. We are not aware of Arth 2000+ Cream being the subject of an approved application. As a new drug without an approved application, the current marketing of Arth 2000+ Cream violates Section 505(a) of the FD&C Act [21 U.S.C. Arth 2000+ Cream § 355(a)].Introduction of such product into interstate commerce is prohibited under § 301(d) of the FD&C Act [21 U.S.C. § 331(d).
To the extent Arth 2000+ Cream is, or could be labeled to be, an over-the-counter (OTC) drug, it is also misbranded under Section 502(c) of the FD&C Act [21 U.S.C. § 352(c)] because it does not contain the required labeling information in an OTC Drug Facts Panel in accordance with 21 CFR § 201.66.
The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under Section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
Kre-Celazine, which is the main ingredient of Arth2000, a complex material consisting of bonding Kre-Alkalyn has been medically and clinically proven to reduce pain and rapidly improves joint…mobility along with reducing inflammation.
These 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 FD&C Act [21 U.S.C. § 321(p)]. A new drug may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in Section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]; see also Section 301(d) of the FD&C Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate the drug is safe and effective.
Furthermore, your products HiBee Heart’n Brain Ultimate Omega-3, Arth 2000+ For Joint Flexibility & Pain Relief (180 capsules), and Arth 2000+ Cream (for its rheumatoid arthritis indication) are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for the intended purposes. Thus, these drugs are misbranded within the meaning of Section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)], in that their labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of Section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
Our inspection of your facility revealed the following significant violations of the CGMP requirements for dietary supplements. These violations cause your dietary supplement products to be adulterated under Section 402(g)(1) of the FD&C Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions which do not meet the CGMP regulations for dietary supplements. Additionally, even if your HiBee Heart’n Brain Ultimate Omega-3 and Arth 2000+ For Joint Flexibility & Pain Relief (180 capsules) products did not contain disease claims in their labeling that cause the products to be unapproved new drugs under Section 505(a) of the FD&C Act [21 U.S.C. § 355(a)], they would still be adulterated dietary supplements within the meaning of Section 402(g)(1) because they have been prepared, packed, or held under conditions which do not meet the CGMP regulations for dietary supplements.
1. Your firm failed to make and keep written procedures for the responsibility of quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103 and 21 CFR 111.140(b)(1). Your firm’s quality control personnel must approve for release, or reject, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution, as required by 21 CFR 111.127(h). You must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement (21 CFR 111.127(h) and 111.140(b)(2)). In addition, you must establish and follow written procedures for the responsibilities of the quality control operations (21 CFR 111.103). However, you provided no written procedures for, or documentation of, the approval for release of your dietary supplements by the quality control personnel.
We have reviewed your response dated February 15, 2013, which includes written procedures you provided for your quality control department. The response is inadequate because it is not specific to your firm, products, equipment, and its processes and operations, and the response does not provide the necessary instructions for your quality control personnel to execute their respective functions and responsibilities. For example, the procedures do not list established specifications, or what the specific procedure or instruction is when quality control rejects a batch and conducts an investigation.
2. You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of a dietary supplement that is specific to the labeling and packaging operations you perform, as required by 21 CFR 111.205(a). Your (b)(6) stated to our investigator during the inspection that your firm does not establish MMRs for any of the firm’s products.
The record fails to include or cross-reference the location of a representative label for the product, as required in 21 CFR 111.210(g).
Your record references “yield” specifications but fails to list what the specifications are, as required in 21 CFR 111.210(h)(1).
Your record fails to include written procedures for sampling and a cross-reference to procedures for tests or examinations, as required in 21 CFR 111.210(h)(2).
Your record fails to provide written instructions on corrective action plans for use when a specification is not met, as required by 21 CFR 111.210(h)(5). Further, your corrective action plan does not identify the exact specification(s) that are not met and written steps to take to when a specification is not met.
3. Your firm failed to make and keep written records for the production and process control system requirements that apply to packaging, labels, and for products that you receive for packaging or labeling as a dietary supplement, as required by 21 CFR 111.180(b)(3)(i). Specifically, you failed to maintain any documentation of the examination of packaging, labels, or products received for the packaging and labeling of products you received as dietary supplements.
We have reviewed your response, dated February 15, 2013, and determined it to be inadequate. Your response included a blank “receiving materials records” form. We cannot evaluate this record and determine if it is adequate to comply with the requirements under 21 CFR 111.165 and 21 CFR 111.180(b)(3) without it being filled out and without having other documents you referenced (e.g., COA, invoice, packing list, etc.).
4. Your firm failed to establish specifications to provide sufficient assurance that products your firm receives from a supplier for packaging and labeling as dietary supplements are adequately identified and are consistent with your purchase order, as required by 21 CFR 111.70(f). Specifically, you did not provide our investigator with established product specifications for products you received for packaging and labeling as dietary supplement.
We have reviewed your response, dated February 15, 2013, and determined it to be inadequate. Your response indicated that you have a written guideline with criteria for accepting or rejecting labels, but you provided no such document with your response that would provide the necessary instructions for your personnel to execute their respective functions and responsibilities.
5. Your firm did not establish written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, your firm receives bulk packaged dietary supplement product for packaging and labeling, but you have no written procedures for holding and distributing operations.
We have reviewed your response, dated February 15, 2013, and determined it to be inadequate. Your response includes written procedures for holding and distributing operations and a “product holding evaluation” sheet. However, a review of your written procedures revealed that they are inadequate to meet the requirement of 21 CFR 111.453 in that you do not provide specific instructions on how and where your products, packaging, and labels are to be held and what measures are provided in your instruction to prevent mix-up (e.g., use of labels to prevent mix-ups; use of placards to designate a product, package, or label is under quarantine and specific exact locations where quarantine products are stored; designated exact staging and holding areas specific to the layout of your facility; etc.).
6. Your firm failed to establish written procedures for packaging and labeling operations, as required by 21 CFR 111.403. Specifically, your firm provided no written procedures for all products you receive for packaging and labeling as a dietary supplement. You have no written procedures for performing packaging and labeling operations, including procedures for accepting or rejecting labels.
We have reviewed your response, dated February 15, 2013, and determined it to be inadequate. Your response includes “Packaging and Labeling Procedures and its checklist.” However, a review of your written procedures and checklist reveals that they are inadequate to meet the requirement of 21 CFR 111.403 in that you do not provide, for example, specific instructions on how rolls of labels are applied to products from what equipment; whether label reconciliation is performed by your employee, with specific instructions; and if 100% examination of correct labels are performed manually with the eyes of the employee or by appropriate electronic or electromechanically equipment during or after completion of finishing operations (see 21 CFR 111.410).
7. You did not establish written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Specifically, you have not established written procedures for the review and investigation of product complaints.
We have reviewed your response, dated February 15, 2013, and determined it to be inadequate. Your response indicates you have a “general written procedure for the handling of product complaints,” but you did not provide it for our review. Rather, you attached “an updated procedure” for handling product complaints in the form of “Customer Complaints Form” and “Returned Product Evaluation” documents, but these documents do not meet the written procedures requirement under 21 CFR 111.553. For example, while it appears this document will be used to collect information regarding customer complaints, it provides no written procedures for your firm to follow to review and investigate product complaints.
Your HiBee Royal 1500, HiBee Rocky Mountains Bee Propolis 500mg, ROCKY HEALTH Mega Albumin 1000, HiBee Heart’n Brain Ultimate Omega 3 and Arth 2000+ (180 caps) products are misbranded within the meaning of Section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event associated with such dietary supplement.
Your HiBee Royal 1500, HiBee Rocky Mountains Bee Propolis 500mg, ROCKY HEALTH Mega Albumin 1000, HiBee Heart’n Brain Ultimate Omega 3 and Arth 2000+ (180 caps) products are misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act [21 U.S.C. § 343(s)(2)(B)] because the labels fail to identify the products as dietary supplements, as required by 21 CFR 101.3(g). 21 CFR 101.3(g) requires that a dietary supplement be identified by the term “dietary supplement” as part of the product’s statement of identity, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product.
Your ROCKY HEALTH Mega Albumin 1000 product is misbranded within the meaning of Section 403(q)(5)(F) of the FD&C Act [21 U.S.C. § 343(q)(5)(F)] in that the nutrition information does not comply with 21 CFR 101.36.
Nutrition information with the title “Supplement Facts” is not declared and the nutrition information is not enclosed in a box using hairlines as required by 21 CFR 101.36(e)(1) and (e)(2), respectively.
Each of the dietary ingredients listed on the label above and beneath it are not separated by a hairline rule centered between the lines of text, as required by 21 CFR 101.36(e)(5).
The label does not include any of the bars required by 21 CFR 101.36(e)(6)-(7) to separate sections of the Supplement Facts panel.
The names of some of the dietary ingredients listed in the Supplement Facts panel are not listed according to the nomenclature specified in 21 CFR 101.9 or in 21 CFR 101.36(b)(2)(i)(B)(2), and they are not listed in their correct order in accordance with 21 CFR 101.36(b)(2)(i)(B). For example, Vitamin D is incorrectly listed between Vitamin B12 and Vitamin E and the proper nomenclature is thiamin (Vitamin B1) and not Vitamin B1 (thiamine Mononitrate).
The dietary ingredient Vitamin B-6 is declared on your label as 0.10 mcg. You incorrectly list the daily value as 5% based on the amount and established RDI. Vitamin B-6 must not be declared as zero because the amount corresponds to less than 2 percent of the RDI for vitamins and minerals under the criteria of 21 CFR 101.36(b)(2) and 21 CFR 101.9(c), and as required by 21 CFR 101.36(b)(2)(i).
Further, your ROCKY HEALTH Mega Albumin 1000 product is also misbranded within the meaning of Section 403(q)(1)(A) and (B) of the FD&C Act [21 U.S.C. § 343(q)(1)(A) and (B)] because the product label fails to list the subheading “Serving Size” and “Servings Per Container,” as required by 21 CFR 101.36(b)(1)(i) and (ii), respectively.
Your Arth 2000+ For Joint Flexibility & Pain Relief (180 Caps) is misbranded within the meaning of Section 403(q)(5)(F) of the FD&C Act [21 U.S.C. § 343(q)(5)(F)] in that the nutrition information does not comply with 21 CFR 101.36.
and its quantitative amount by weight per serving must be listed in the “Supplement Facts” panel as required by 21 CFR 101.36(b)(3)(ii).
Further, your Arth 2000+ For Joint Flexibility & Pain Relief (180 Caps), HiBee Heart’n Brain Ultimate Omega and ROCKY HEALTH Mega Albumin 1000 are misbranded within the meaning of Section 403(i)(2) of the FD&C Act [21 U.S.C. § 343(i)(2)]. For example, your Arth200+ For Joint Flexibility & Pain Relief declares the ingredients Kre-Celazine® Pictogen™, and MYT™, but these ingredients are not declared by their common or usual names, which is required by 21 CFR 101.36(b)(3) and 21 CFR 101.4. And, your HiBee Heart’n Brain Ultimate Omega and ROCKY HEALTH Mega Albumin 1000 do not declare the capsule and softgel ingredients as required by 21 CFR 101.4.
Further, your Arth 2000+ For Joint Flexibility & Pain Relief (180 Caps) is misbranded within the meaning of Section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)], in that the label fails to identify the part of the plant (e .g., root, leaves) from which botanical dietary ingredients in the product is derived, as required by 21 CFR 101.4(h)(1). For example, your product lists the ingredient, boswellia extract, but does not identify the part of the plant used.
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 your firm complies with all requirements of federal law and 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/or injunction.
Within fifteen (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 all corrective actions within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Section 743 of the FD&C 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 FD&C 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 FD&C Act. Accordingly, FDA may assess fees to cover reinspection-related costs.
Your response should be directed to Rosemary Sexton, Compliance Officer, Food and Drug Administration, 550 W. Jackson Blvd., 15th floor, Chicago, IL 60661. Refer to the Unique Identification Number (CMS case # 393929) when replying. If you have any questions about the content of this letter, you may contact Ms. Sexton at 312-596-4225 or via email at rosemary.sexton@fda.hhs.gov.

References: § 342
 § 201
 § 321
 § 355
 § 301
 § 331
 § 352
 § 201
 § 331
 § 321
 § 355
 § 331
 § 352
 § 331
 § 342
 § 355
 § 343
 § 343
 § 343
 § 343
 § 343
 § 343
 § 343
 § 379
 § 379