Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm404345.htm
Timestamp: 2019-04-23 02:20:35+00:00

Document:
On May 9 through May 28, 2013, the U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility located at 13859 Redwood Avenue, Chino, California. During the inspection, our investigators found significant violations of the Current Good Manufacturing Practice (CGMP) regulations 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 the dietary supplements manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that the dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
Additionally, our investigators collected and reviewed the labels for your (b)(4) and (b)(4) dietary supplement products during the inspection of your facility. Based on our review of your labels, we have determined that your (b)(4) dietary supplement product is promoted for conditions that cause it to be a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your label establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease.
Our investigators’ observations were noted on form FDA-483, Inspectional Observations, which was issued to you on May 28, 2013. We also received your written responses, dated June 14, 2013, September 16, 2013, and November 7, 2013, and address your written responses below.
You may find the Act and the FDA’s regulations through links on FDA’s home page at http://www.fda.gov.
Your (b)(4) product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a “new drug” under section 201(p) of the 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 discussed in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the 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 that the drug is safe and effective.
Furthermore, your (b)(4) product is offered for a condition that is 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 this drug safely for its intended purposes. Thus, this drug is misbranded within the meaning of section 502(f)(1) of the Act, in that its labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
1. You failed to 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). Specifically, you did not conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient.
We received your responses dated June 14, 2013, September 16, 2013, and November 7, 2013. While we recognize the corrective actions that you have taken to address the requirement to verify the identity of your dietary ingredient, (b)(4), your responses do not adequately address all of the requirements. Specifically, in your response dated November 7, 2013, you provided a Raw Material Specification Sheet for (b)(4), which indicates that you used (b)(4) as a test to verify the identity of your dietary ingredient. However, your response is inadequate because you have not demonstrated that you are ensuring that (b)(4) is an appropriate, scientifically valid method, as required by 21 CFR 111.75(h)(1). We are therefore unable to determine the adequacy of your proposed corrective actions at this time.
2. 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). Specifically, you did not establish specifications for each component that you use in the manufacture of your dietary supplements.
We received your responses dated June 14, 2013, September 16, 2013, and November 7, 2013. While we recognize the corrective actions that your firm has taken to address the requirement to establish specifications for your components, your responses do not adequately address all of the requirements. Specifically, in your response dated November 7, 2013, you provided your (b)(4) Raw Material Specification sheet. However, your (b)(4) Raw Material Specification sheet does not include specifications for identity and component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the component are met, and limits on those types of contaminations that may adulterate or may lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.70(b).
3. You failed to ensure that the tests and examinations you use to determine whether specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1). Specifically, your “Master Incoming Material Specification Sheet” states that (b)(4) was used as the “Test/Exam Method” for (b)(4) and (b)(4), which are dietary ingredients used in the manufacture of your (b)(4) dietary supplement product. However, you have not demonstrated that (b)(4) is an appropriate, scientifically valid test to identify these dietary ingredients.
We received your responses dated June 14, 2013, September 16, 2013, and November 7, 2013. While we recognize the corrective actions that your firm has taken to address the requirement to ensure the tests you use to determine whether specifications are met are appropriate, scientifically valid methods, your responses do not adequately address all of the requirements. Specifically, you provided (b)(4) as the methodology to verify the identity of the dietary ingredients (b)(4) and (b)(4). However, your response did not demonstrate that (b)(4) is an appropriate, scientifically valid test to verify the identity of these dietary ingredients.
4. You failed to prepare and follow a written master manufacturing record (MMR) 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, you informed our investigator that you have a blank MMR, which is then used as a batch record when a dietary supplement order is received. However, you must prepare and follow a written MMR 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).
We received your responses dated June 14, 2013, September 16, 2013, and November 7, 2013. While we recognize the corrective actions that you have taken to address the requirements for your MMRs, your responses do not adequately address all of the requirements. Specifically, you did not provide written instructions for procedures for sampling and a cross reference to procedures for tests or examinations, as required by 21 CFR 111.210(h)(2).
5. Your quality control personnel failed to ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplements and that the dietary supplements are packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.105. Specifically, your quality control unit approved for distribution (b)(4) capsules of your (b)(4) dietary supplement product (b)(4) after test results reported that the strength of your dietary supplement product did not meet your finished product specifications. Your quality control operations for laboratory operations associated with the production and process control system must include ensuring that all tests and examinations required under 21 CFR 111.75 are conducted, as required by 21 CFR 111.110(b).
We received your responses dated June 14, 2013, September 16, 2013, and November 7, 2013. While we recognize the corrective actions that you have taken to address the requirements for quality control personnel, your responses do not adequately address all of the requirements. Specifically, you did not provide documentation showing that your quality control personnel are ensuring that all tests and examinations required under 21 CFR 111.75 are conducted prior to releasing your dietary supplement products, in accordance with 21 CFR 111.110(b). We are therefore unable to determine the adequacy of your proposed corrective actions at this time.
1. Your (b)(4) is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that the product label fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
2. Your (b)(4) is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343 (s)(2)(C)] because the label fails to identify the part of the plant from which (b)(4) is derived in accordance with 21 CFR 101.4(h)(1).
The listing of dietary ingredients includes (b)(4) and (b)(4) but (b)(4) and (b)(4) are not common or usual names for these dietary ingredients.
This letter may not list all the violations at your facility or that exist in connection with your products or their labeling. 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. You are responsible for ensuring that your products are in compliance with the Act and all applicable FDA regulations, including the CGMP regulation for dietary supplements. You should take prompt action to correct the violations cited in this letter and prevent their recurrence. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
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 re-inspection-related costs. A re-inspection 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-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 re-inspection-related costs.
You should notify this office in writing within fifteen (15) working days of receiving this letter of the steps you have taken to correct the violations described above and to prevent similar violations in the future. Your response should include documentation to show that correction has been achieved. If corrective action cannot be completed within 15 days, state the reason for the delay and the time frame within which the corrections will be completed.
Refer to the Unique Identification Number FEI # 3004130952 when replying. If you have any questions about the content of this letter please contact: Dr. William Vitale at 949-608-2919.

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