Inspections, Compliance, Enforcement, and Criminal Investigations
USPlabs, LLC 12/4/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
December 4, 2012
UPS OVERNIGHT MAIL
Jacob Geissler, CEO and Co-Owner
10761 King William Drive
Dallas, Texas 75220
Dear Mr. Geissler:
From February 7 through 21, 2012, the U.S. Food and Drug Administration (FDA) inspected your facility located at the above-referenced address. During the inspection, our investigators evaluated the manufacturing of several of your products, which you label as dietary supplements, including Jack3d, OxyElite Pro, and Super Cissus.1
In addition to the inspection, our investigators reviewed the labeling for your products found on your website http://www.usplabsdirect.com in October 2012. Based on our review, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and the referenced regulations through links on FDA's homepage at www.fda.gov.
Unapproved New Drug Violations
Based on our review of the labeling of your product, Super Cissus, from your website at www.usplabsdirect.com, and information your firm provided during the inspection, we have concluded that this product is promoted for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Act [21 U.S.C. § 321 (g)(1)(B)]. The claims on your labeling establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your product with these claims violates the Act.
Your labeling contains disease claims including:
• "Cissus quadrangularis, has been found to reduce LDL .... In an eight-week randomized, double blind, placebo-controlled study ... obese subjects taking Cissus experienced reductions in ... LDL .... "
Your product Super Cissus is not generally recognized as safe and effective for the above referenced uses and, therefore, it is also a new drug under section 201 (p) of the Act [21 U.S.C. § 321 (p)]. A new drug may not be legally marketed in the United States without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C.§ 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.
Furthermore, your product is 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 layman can use this drug safely for their intended uses. Thus, this product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that its 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 Act [21 U.S.C. § 331 (a)].
Adulterated Dietary Supplements
In addition, even if your product listed above was not an unapproved new and misbranded drug, it and the other products distributed under your firm's label would be adulterated dietary supplements within the meaning of section 402(g)(1) of 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 the requirements set forth in the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations, Part 111, (21 CFR Part 111).
Based on the records reviewed during this inspection, your firm sends raw materials to contract manufacturers who manufacture (b)(4) dietary supplements including Jack3d, OxyElite Pro, Prime, and Super Cissus various packaging configurations and flavors, and then return the finished products to USPlabs for distribution under your firm's own label. As a dietary supplement distributor that contracts with another contract manufacturer to manufacture dietary supplement under your firm's name, your firm is ultimately responsible for complying with the requirements relating to manufacturing operations [see 72 Fed. Reg. 34752, 34790; June 25, 2007]. Your firm has an obligation to know what and how manufacturing activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution.
Furthermore, we received your firm's written responses with attachments from Lorena Macias, Quality Assurance and Quality Control Director, dated March 14 and June 1, 2012, to the Form FDA 483 (inspectional observations) that was issued to your firm at the conclusion of the inspection on February 21, 2012. We respond to your firm's written responses, below.
Specific violations are as follows:
1. Your firm failed to establish and follow written procedures, as required by 21 CFR 111.553, for the review and investigation of product complaints, as required by 21 CFR 111.560(c). Specifically, your firm's revised procedures related to product complaints in your written procedures entitled "Consumer Complaints (QA-020)" submitted in your March 14, 2012 response to the FDA-483 do not account for the requirements of 21 CFR 111.560(c) in that the procedures do not provide written instructions that quality control personnel review and approve decisions about whether to investigate a product complaint and review and approve the findings and follow-up action of any investigation performed.
2. Your firm failed to establish product specifications for the identity and purity of the finished batch of 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). For each dietary supplement you have manufactured, it is your firm's responsibility to establish product specifications for limits on those types of contamination that may adulterate, or that may lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.70(e). As stated in the final rule (72 FR 34752 at 34837; June 25, 2007), "the manufacturer has the responsibility to determine what types of contamination are likely or certain to contaminate a given product and to determine what types of tests to conduct and when to test for such contamination." Based on information in your supplier's COAs for certain raw materials, chemicals and pesticides are likely or certain to contaminate these raw materials; however, your firm did not establish specifications related to chemicals and pesticides for products that contain these raw materials, including Jack3d Lemon Lime, OxyElite Pro, and Prime.
Your firm's March 14 and June 1, 2012 responses, including attachments, were reviewed and determined to be inadequate. The product specification sheets you provided for many of your dietary supplement products, including Jack3d Lemon Lime, OxyElite Pro, and Prime were inadequate because the product specifications sheets failed to include identity and purity specifications for these products. You also failed to include any specifications related to chemical and pesticides listed on these sheets.
3. Your firm's quality control operations for the master manufacturing record (MMR) failed to include reviewing and approving all master manufacturing records and all modifications to the master manufacturing records, as required by 21 CFR 111.123(a)(1). Specifically, our review of your Jack3d Master Formula revealed that it was not approved by your quality control operations.
Your firm's March 14 and June 1, 2012 responses were reviewed and determined to be inadequate. Your response included your firm's Standard Operating Procedures (SOP) # QA-036, Finished Dietary Supplement Formula and MMR Approval, which indicates that your contract manufacturers submit all product formulas and master manufacturing records for review and approval. However, your response did not include an MMR reviewed and approved for Jack3d.
4. Your firm did not conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1)(i). Your firm supplies its contract manufacturer with raw materials, including dietary ingredients, which are used by another manufacturer in the manufacture of your firm's dietary supplements; however, our investigators found that you did not conduct at least one test or examination to verify the identity of such dietary ingredients, as required by 21 CFR 111.75(a)(1). Instead, your firm relied on Certificates of Analysis (COA) from your suppliers. A COA from a supplier may not be used to verify the identity of any component that is a dietary ingredient [see 21 CFR 111.75(a)]. Specifically, your firm supplies (b)(4) dietary ingredients to its contract manufacturer for the use in production of two of your own label dietary supplement products, Jack3d and OxyELITE Pro. Your firm routinely receives and accepts (b)(4) incoming dietary ingredients into its facility with accompanying Certificates of Analysis and does not verify the identity of these dietary ingredients before sending them to the contract manufacturer for use in the manufacture of your own label dietary supplement products.
Before using a component that is a dietary ingredient, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you have petitioned FDA for an exemption from such testing, consistent with the requirements in 21 CFR 111.75(a)(1)(ii), and FDA has granted such petition. Your firm has not petitioned FDA for such an exemption.
Furthermore, if you would like to rely on a certificate of analysis from the supplier of the components (other than dietary ingredients) you receive for use in your firm's dietary supplement products to confirm the identity of such components, you must comply with the requirements in 21 CFR 111.75(a)(2)(ii).
5. Your firm's quality control personnel failed to approve or reject all processes, written procedures, controls, tests and examinations, and deviations from or modifications to them, that may affect the identity, purity, strength, or composition of a dietary supplement, as required by 21 CFR 111.105(a). For example, your firm's quality control personnel did not approve testing methods for (b)(4)
Your firm's March 14 and June 1, 2012 responses were reviewed and determined to be inadequate. You indicated that your Quality Assurance and Quality Control Director will review all test methods, but you did not provide any supporting documentation that any test methods were actually reviewed by your Director.
6. Your firm's master manufacturing record (MMR) for the dietary supplement product Jack3d failed to identify specifications for the points, steps, or stages 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 your MMR, as required by 21 CFR 111.205(b)(1). In addition, your firm's MMR for this product failed to establish controls and procedures to ensure that each batch of dietary supplements that you manufacture meets the specifications identified, as required by 21 CFR 111.205(b)(2). Your firm's MMR for this dietary supplement product, failed to include the following information required by 21 CFR 111.210:
• A complete list of components to be used, as required by 21 CFR 111.210(b). For example, the sodium copper chlorophyll in is listed on your product label, but not on the MMR.
• A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finished manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made, as required by 21 CFR 111.210(f);
• A description of the packaging and a representative label or a cross-reference to the physical location of the actual or representative label, as required by 21 CFR 111.210(g).
• Written instructions, including 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 master manufacturing record, as required by 21 CFR 111.210(h)(1);
• Procedures for sampling and a cross reference to procedures for tests and examinations, as required by 21 CFR 111.210(h)(2);
• Specific actions necessary to perform and verify points, steps, or stages 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. For your manual operations, such actions include the following:
o One person to weigh or measure a component and another person to verify the weight or measure, as required by 21 CFR 111.210(h)(3)(ii)(A); and
o One person adding the component and another person verifying the addition, as required by 21 CFR 111.210(h)(3)(ii)(B);
• The written instructions in your master manufacturing records did not include corrective action plans to use when a specification is not met, as required by 21 CFR 111.210(h)(5).
The above violations cited in this letter are not meant to be an all-inclusive list of violations in your products and their labeling. It is your responsibility to ensure that your products are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations cited in this letter and prevent their recurrence. Failure to do so may result in enforcement action by FDA without further notice, such as seizure and/or injunction.
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)). 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.
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 noncompliance 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 from your receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions or steps towards long term corrective actions. If you cannot complete all corrective actions before you respond, you should explain the reason for your delay and state when you will correct the remaining deficiencies.
Your written response should be sent to Thao Ta, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, TX, 75204. If you have questions regarding any issues in this letter, please contact Mr. Ta at (214)253-5217.
Reynaldo R. Rodriguez, Jr.
1 On April 24, 2012, we sent your firm a warning letter concerning the use of 1,3 dimethylamylamine HCL (dimethylamylamine), which is declared on the labeling for your products, Oxy Elite Pro and Jack 30, as a dietary ingredient. Your firm, through its attorney, responded to the April 2012 warning letter on May 17, 2012 and provided supplemental information on September 28, 2012. FDA is currently considering the information in your correspondence and intends to respond in a separate letter.