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Inspections, Compliance, Enforcement, and Criminal Investigations
Kanec USA, Inc. 10/8/10
Department of Health and Human Services
Food and Drug Administration555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
Ebere J. Ikejiani, President Azubueze Ikejiani, Vice President Kanec USA, Inc. 5061 South State Road 7, U602 Davie, Florida 33314
The United States Food and Drug Administration (FDA) conducted an inspection of your facility at the address referenced above on March 31, 2010, and April 1, 5, 8, and 19, 2010. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act (the Act), as described in more detail below.
UNAPPROVED, MISBRANDED, AND PRESCRIPTION DRUGS
Your products, "STUD Capsule For Men" and "XOX For Men," are labeled as dietary supplements. However, as you were informed, FDA confirmed through laboratory analysis that "STUD Capsule For Men" contains sildenafil. You were also informed that FDA confirmed through laboratory analysis that "XOX For Men" contains both sildenafil and tadalafil. Sildenafil and tadalafil are phosphodiesterase type-5 (PDE-5) inhibitors and are the active pharmaceutical ingredients in the prescription drugs Viagra and Cialis, respectively, which are approved for erectile dysfunction. According to section 201 (ff)(3)(B), 21 U.S.C. § 321 (ff)(3)(B), dietary supplements cannot contain an article that is approved as a new drug under section 505 of the Act unless that article was marketed as a dietary supplement or food prior to FDA approval of such drug. FDA approved Viagra as a new drug on March 27, 1998, and sildenafil was not marketed as a dietary supplement or as a food before this date. FDA approved Cialis as a new drug on November 21, 2003, and tadalafil was not marketed as a dietary supplement or as a food before this date. As such, "STUD Capsule For Men" and "XOX For Men" are not dietary supplements.
Rather, "STUD Capsule For Men" and "XOX For Men" are drugs as defined by section 201(g)(1) of the Act, 21 U.S.C. §321 (g)(1). Statements on your products labels describe their intended uses. Specifically, the labels of "STUD Capsule For Men" and "XOX For Men" state, "[W]orks in as quickly as 45 minutes and helps increase sexual pleasure and improve sexual performance." This statement makes clear that "STUD Capsule For Men" and "XOX For Men" are intended to affect the structure or function of the human body and/or prevent, treat, or cure disease conditions. Accordingly, "STUD Capsule For Men" and "XOX For Men" are drugs, as defined by Section 201(g)(1) of the Act, 21 U.S.C. § 321(g)(1).
Moreover, these products are "new drugs" under section 201(p) of the Act, 21 U.S.C. §321(p), because they are not generally recognized as safe and effective for their labeled uses. Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of "STUD Capsule For Men" and "XOX For Men" without approved applications violates these provisions of the Act.
Furthermore, your products are "prescription drugs" as defined at section 503(b)(1)(A) of the Act, 21 U.S.C. §353(b)(1)(A), in that their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary to their use, are not safe for use except under the supervision of a practitioner licensed by law to administer them. Indeed, all PDE-5 inhibitors that have been approved for marketing by FDA are limited by an approved new drug application to use under the professional supervision of a practitioner licensed by law to administer such drugs.
"STUD Capsule For Men" and "XOX For Men" are misbranded under Section 502(f)(1) of the Act because their labeling fails to bear adequate directions for use. "Adequate directions for use" mean directions under which the layman can use the drug safely and for the purposes that it is intended. 21 C.F.R. §201.5. Sildenafil and tadalafil are the active ingredients of prescription drugs, and prescription drugs can only be used safely at the direction and under the supervision of a licensed healthcare practitioner. Therefore, adequate directions for use by laymen cannot be written for "STUD Capsule For Men" or "XOX For Men." Because no approved FDA application is in effect for either product, they are not exempt from this labeling requirement under 21 C.F.R. 200.100. As such, these products are misbranded under section 502(f)(1) of the Act, 21 U.S.C. §352(f)(1).
Additionally, under section 502(a) of the Act, 21 U.S.C. §352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201 (n) of the Act, 21 U.S.C. §321 (n), provides that, in determining whether a drug's labeling or advertising "is misleading, there shall be taken into account . not only representations made or suggested . but also the extent to which the labeling or advertising . fails to reveal facts material in light of such representations ." The labeling of "STUD Capsule For Men" and "XOX For Men" bear the phrase "Herbal Supplement" and do not declare that they contain sildenafil or tadalafil. The undeclared ingredients in your products may pose a serious health risks because patients with underlying medical issues may take one of your products without knowing that it can cause serious harm or interact, in dangerous ways, with other drugs. For example, sildenafil or tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin), and can lower blood pressure to dangerous levels. Further, FDA analysis of "STUD Capsule for Men" revealed that the product contained more than 200mg per capsule of sildenafil-- more than 8-times the normal starting dose of the approved product. Doses in this range are expected to result in an increased incidence of side effects and an amplification of the adverse event profile in healthy patients. For example, the incidences of dyspepsia and blue vision are higher at 150mg than at 100mg. Similarly, the vasodilatory effects of sildenafil are greater at doses above 100mg, with the incidence of dizziness and hypotension increasing from 100mg to 800mg. The failure to disclose the presence of sildenafil or tadalafil renders your products' labeling false and misleading. Therefore, the labels of these products are false and misleading, thereby causing them to be misbranded under section 502(a) of the Act, 21 U.S.C.
The inspection also revealed significant violations of CGMP regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations Parts 210 and 211, thereby causing the drug products manufactured by your firm to be adulterated within the meaning of section 501 (a)(2)(B) of the Act, 21 U.S.C. § 351(a)(2)(B).
We have reviewed your firm's response of April 27, 2010, and note that it lacks sufficient corrective actions for these deviations. Specific violations observed during the inspection include, but are not limited, to the following:
1. Your firm has not established a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products [21 C.F.R. § 211.22(a)]. For example, your firm has failed to establish a Quality Control Unit (QCU) with written procedures that define its responsibilities and procedures. In your response, you state that you will develop and implement the procedure, "Standard Operating Procedures for Cleaning, Raw Materials Testing, Weighing of Materials, Mixing of Raw Materials, Content Uniformity Analysis, and Weight Variation of Finished Products-Capsules." Your response is inadequate because you have not provided the referenced procedures in this document or a timeframe for implementation. In addition, your response fails to address the requirement for written procedures describing the responsibilities of your QCU.
2. Your firm has not established scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, in-process materials, and drug products conform to appropriate standards of identity, strength, quality, and purity [21 C.F.R. § 211.160(b)]. For example, your firm does not conduct any testing of raw materials or the resultant drug product. In your response, you commit to developing written procedures for, "Raw Materials Testing, Weighing of Materials, Mixing of Raw Materials, Content Uniformity Analysis, and Weight Variation of Finished Products-Capsules." Your response is inadequate because it does not address the finished product testing for strength of the active ingredients. In addition, your response does not specify a timeline for completion of the corrective action.
3. Your firm does not have any written procedures for production and process controls designed to assure that the drug products you manufacture have the identity, strength, quality, and/or purity they purport or are represented to possess [21 C.F.R. § 211.100(a)]. For example, your firm has failed to validate any of your manufacturing processes or develop any written procedures for such processes. In your response, your firm has committed to create, "Standard Operating Procedures for Cleaning, Raw Materials Testing, Weighing of Materials, Mixing of Raw Materials, Content Uniformity Analysis, and Weight Variation of Finished Products-Capsules." In addition, your firm has proposed to develop a procedure for calculating theoretical and actual outputs for liquid drug products and has committed to validating this procedure. Your response is inadequate because your firm does not: (1) commit to validating your drug manufacturing processes; (2) commit to developing written procedures for your manufacturing processes; or (3) provide a timeframe for completing the proposed corrective actions.
4. Your firm has failed to prepare batch production and control records for each batch of drug product produced including, complete information relating to the production and control of each batch [21 C.F.R. § 211.188]. For example, your firm does not prepare any records to document production of your drug products. In your response, you state that "Batch records will be maintained for each production including the weight of empty capsules and filled capsules as well as calculations of theoretical and actual yields," and "batch production and quality control records files are to be maintained as required by the SOP being created and for all future processes." Your response is inadequate because you have not provided copies of any batch record or written procedures for maintaining your batch production and quality control records. In addition, your response does not describe a timeframe for completing the corrective actions.
In addition, you proposed corrective actions concerning deviations from food (supplement) and device regulations that we noted during the inspection. Please be advised that, as with your responses to the drug CGMP deficiencies, these promised corrective actions are also inadequate in that you have not provided us with enough information to make a reasonable evaluation of your compliance status.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. 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 assure that your firm complies with all requirements of federal law and FDA regulations, including those pertaining to your dietary supplement and medical device products.
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 injunction as the Act authorizes under sections 302 and 304 of the Act, 21 U.S.C. §§ 332 and 334. In addition, there is criminal liability for all violations of the prohibited acts described in section 301 of the Act, 21 U.S.C. §331 Other federal agencies may take this Warning Letter into account when considering the award of contracts. Additionally, FDA may withhold approval of requests for export certificates: or approval of pending new drug applications listing your facility as a manufacturer until the above violations are corrected. Furthermore, FDA may reinspect your facility to verify that corrective actions have been completed.
Within fifteen (15) working days of receiving this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations and the current status of the "STUD Capsule For Men" and "XOX For Men" nationwide recall, as well, as copies of related documentation. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you no longer manufacture or market any of your drug products, please indicate this in your response, including the reasons and the date on which you ceased production.
Please send your response to the attention of Matthew B. Thomaston, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have questions regarding any issue in this letter, please contact Mr. Thomaston at (407) 475-4728.
/S/ Emma R. Singleton Director, Florida District
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