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2013 > V-SAB Medical Labs, Inc. 4/26/13
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Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning
Letters
Inspections, Compliance, Enforcement, and Criminal Investigations
V-SAB Medical Labs, Inc. 4/26/13
Public Health Service
Food and Drug Administration
60 Eighth Street, NE
Atlanta, GA 30309
Telephone: 404-253-1161
Department of Health and Human Services
April 26, 2013
VIA UNITED PARCEL SERVICE
WARNING LETTER
13-ATL-15
Rashid A. Buttar, D.O.
President and Chief Operating Officer
V-SAB Medical Labs, Inc.
20905 Torrence Chapel Rd.
Suite #204
Cornelius, NC 28031
Dear Dr. Buttar:
This letter is in reference to the inspection conducted of your firm, V-SAB Medical Labs, Inc., on
May 22, 2012 through June 20, 2012 and your firm’s manufacture, marketing, and distribution
of the topically administered products: Trans-D Tropin, TD-DMPS, and Progesterone-3/.3. Your
products are manufactured, marketed, and distributed in violation the Federal Food, Drug, and
Cosmetic Act (“the Act”) as described herein.
You promote the aforementioned products on your websites, which include www.drbuttar.com,
www.TransD.com, and www.balancenutraceutical.com, as well as in YouTube videos and during
radio appearances. These websites and media demonstrate that your products are intended for
the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or are intended to
affect the structure or function of the body of man. Therefore, your products are drugs as
defined by section 201(g) of the Act, [21 U.S.C. §321(g)]. Examples of the claims for your
products include, but are not limited to, the following:
Trans-D Tropin
The following statements are located in your Trans-D Tropin product brochure located on your
website, www.TransD.com, through which you sell Trans-D Tropin:
“Trans-D Tropin is the world’s first and only Transdermal Growth Hormone Releasing
(GHRH) Analog. . . . Recent studies show statistically significant increases in hGH levels
from baseline, after treatment with Trans-D Tropin.”
“You are a candidate for Trans-D Tropin® if you have: Chronic Pain (e.g. Arthritis) . . .
Blood Sugar Abnormalities (hypoglycemia or hyperglycemia) [,] Elevated LDL Cholesterol
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[,] Reduced HDL Cholesterol . . . Emotional Instability and/or Depression . . . Reduced Sex
Drive [,] Reduced Sexual Potency/Performance”
“What are some of the Benefits of Trans-D Tropin? Doctors and Patients report . . . Faster
healing and quicker recovery from acute injuries and after surgical procedures . . .
Reduction in chronic pain from old injuries . . . Renewed interest in sex with enhanced
performance and ability . . . Decrease in anxiety, stress and depression. . . Decrease in
occurrence of general illness due to strengthened immune system”
TD-DMPS
The following statement is located on your TD-DMPS product container label:
“Indications: May be used by your physician for heavy metal detoxification.”
Progesterone-3/.3
The following statements are located in your Progesterone-3/.3 product container label and
product brochure, respectively:
”Indications: For use in female hormonal imbalances.”
“Progesterone 3/.3 is indicated in female patients that may be experiencing symptoms of
estrogen dominance and/ or adrenal exhaustion. In addition, patients may benefit from the
administration of Progesterone 3/.3 if they are seeking to increase bone mass density . . .
prevent or reduce the symptoms of fibrocystic breast disease and uterine fibroids, reduce
the symptoms of PMS, improve and maintain the uterine lining (as is beneficial in
endometriosis . . . alleviate depression and anxiety . . .”
Furthermore, your various websites contain links to articles and videos about the purported
utility of your products. When such references are used commercially by the seller of a product
to promote the product to consumers, such references may become evidence of the product’s
intended uses. A citation of a publication or reference in the labeling of a product is considered
to be a claim about the disease treatment or prevention if the citation refers to a disease use,
and if the citation implies treatment or prevention of a disease in the context of the labeling as
a whole. The following are examples of articles or papers used on your websites to market your
products:
Buttar, Rashid A. The Inter-relationship between Growth Hormone, IGF – 1, and Cancer.
Available from https://www.transd.com/growth-Hormone-IGF-1-cancer.php1.
Buttar, Rashid A. Position Statement regarding Dr. Buttar’s TD-DMPS® Treatment
Protocol. Available from http://www.drbuttar.com/patient-resources.html2.
Bernhoft, Robin and Buttar, Rashid. Autism: A Multi-System Oxidative and Inflammatory
Disorder. Townsend Letter. 2008 April; 86-90. Available from
http://www.drbuttar.com/patient-resources.html3.
The intended uses of your products, Trans-D Tropin, TD-DMPS, and Progesterone-3/.3, make
clear that they are drugs as defined in section 201(g)(1) of the Act [21 U.S.C. §321(g)
(1)]. Moreover, these products are new drugs as defined in section 201(p) of the Act [21 U.S.C.
§321(p)] because your drugs are not generally recognized as safe and effective for use under
the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of
the Act [21 U.S.C. §355(a)], a new drug may not be introduced or delivered for introduction
into interstate commerce unless an approved application is in effect for it. 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. The introduction of a drug into interstate commerce that is in violation of
505 is a violation of section 301(d) of the Act [21 U.S.C. §331(d)].
Your products, Trans-D Tropin, TD-DMPS, and Progesterone-3/.3, are also misbranded within
the meaning of section 502(f)(1) of the Act [21 U.S.C. §352(f)(1)], in that the labeling fails to
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bear adequate directions for use. Trans-D Tropin, TD DMPS, and Progesterone .3/3 are
considered prescription drugs under section 503(b)(1) of the Act [21 U.S.C. §353(b)(1)] and
are not exempt under 21 C.F.R. §§201.100(c)(2) and 201.115 from the requirement that their
labeling bear adequate directions for use because these products lack approved applications.
The introduction of a misbranded drug into interstate commerce is a violation of section 301(a)
and/or 301(k) of the Act [21 U.S.C. §§331(a) and/or 331(k)].
In addition, our investigator(s) identified significant violations of current good manufacturing
practice (CGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations,
Parts 210 and 211. These violations cause your drug products to be adulterated within the
meaning of section 501(a)(2)(B) of the Act [21 U.S.C. §351(a)(2)(B)] in that the methods used
in, or the facilities or controls used for, their manufacture, processing, packing, or holding do
not conform to, or are not operated or administered in conformity with, CGMP.
Our investigator(s) observed specific violations during the inspection, including, but not limited
to, the following:
CGMP Violations
1. Your firm does not have, for each batch of drug product, appropriate laboratory
determination of satisfactory conformance to final specifications for the drug product, including
the identity and strength of each active ingredient, prior to release (21 C.F.R. §211.165(a)).
For example, no analytical testing is performed to assess conformance to specifications
including the strength of each active pharmaceutical ingredient prior to releasing products for
distribution.
This is a repeat observation from the 2010 inspection.
2. Your firm failed to conduct at least one specific identity test to verify the identity of each
component (21 C.F.R. §211.84(d)(1)).
For example, your firm did not conduct a specific identity test for the progesterone component
lot (b)(4) used to manufacture Progesterone-3/.3, lot 12065.751, on March 5, 2012. During
the inspection, your lab director confirmed that your firm does not have the instrumentation
needed to perform specific identity testing and indicated that (b)(4) was conducted for this
component. However, you had no documentation of the (b)(4) test results for progesterone. In
your response, provide your plans (e.g., using a contract laboratory) for performing this specific
identification test on each incoming component lot, and provisions for addressing inadequate
documentation of testing performed by your laboratory.
3. Your firm failed to establish an adequate written testing program designed to assess the
stability characteristics of drug products and to use results of such stability testing to determine
appropriate storage conditions and expiration dates (21 C.F.R. §211.166(a)).
For example, all of your products are labeled with a 1-year expiration date; however, there is
no stability data to support this expiration dating.
This is a repeat observation from the 2010 inspection.
4. Your firm failed to establish laboratory controls that include scientifically sound and
appropriate specifications, standards, sampling plans, and test procedures designed to assure
that components, drug product containers, closures, in-process materials, labeling, and drug
products conform to appropriate standards of identity, strength, quality, and purity (21 C.F.R.
§211.160(b)).
For example, your test methods for the determination of total aerobic counts in topically applied
products do not include instructions for preparation of media, provisions for the use of positive
and negative controls, growth promotion testing, or instructions that require the use of suitable
oxygen-permeable bags for incubating your plates.
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In addition, you have not established adequate specifications for objectionable microorganisms
in your drug products based on the products intended use. For example, your topical products
should be free of Staphylococcus aureus and Pseudomonas aeruginosa. However, your firm
does not test for these organisms, and you have not performed an evaluation of your products
to determine the organisms that are objectionable for these products. This is a repeat
observation from the 2010 inspection.
Repeat citations from prior inspections indicate that your quality control unit is not exercising its
responsibilities, and may not have the appropriate authority to carry out its responsibilities. Due
to continuing CGMP issues at your firm, if you intend to continue to manufacture drug products
we recommend you engage a third party consultant with appropriate CGMP expertise to assess
your firm’s facility, procedures, processes, and systems to ensure that the drug products you
manufacture have their appropriate identity, strength, quality, purity and safety.
Your firm, V-SAB Medical Labs, distributes the before-mentioned unapproved new, misbranded,
and adulterated drugs in interstate commerce to other physicians and healthcare providers in
violation of sections 301(d) and 301(a) of the Act [21 U.S.C. §§331(d) and (a)]. You also hold
these drugs for use in your own medical practice, SA’Buttar Health and Medical, PC (d.b.a.
Center for Advanced Medicine and Research) in violation of section 301(k) of the Act [21 U.S.C.
§331(k)].
The issues and 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, with respect to the products specifically identified in this
letter and also with respect to all other products that you manufacture. It is your responsibility
to ensure that your firm complies with all requirements of federal law and FDA regulations. In
this regard, please note that products are misbranded under section 502(j) of the Act [21
U.S.C. §352(j)] if they are dangerous to health when used in the dosage or manner; or with the
frequency or duration prescribed, recommended, or suggested in the products’ labeling.
You should take prompt action to correct the violations addressed in this letter. Failure to
promptly correct these violations may result in legal action, without further notice, including,
without limitation, seizure and injunction. Other federal agencies may take this Warning Letter
into account when considering the award of contracts.
Please notify this office in writing within fifteen (15) working days from the date you receive
this letter of the specific steps you have taken to correct the noted violations. Include an
explanation of each step being taken to prevent recurrence of violations as well as any
documentation necessary to show that correction has been achieved. If corrective actions
cannot be completed within fifteen working days, state the reason for the delay and the time
within which you will complete the corrections. Additionally, if another firm manufactures the
product identified above, your reply should include the name and address of the
manufacturer. If the firm from which you receive the product is not the manufacturer, please
include the name of your supplier in addition to the manufacturer.
Your written response should be sent to Marie Mathews, Compliance Officer, U.S. Food and
Drug Administration, 60 Eighth Street NE, Atlanta, Georgia 30309. If you have any questions
about this letter please contact Ms. Mathews at (404) 253-1279 or by email at
[email protected].
Sincerely,
/S/
John R. Gridley, Director
Atlanta District
Cc
Dean Viktora CEO,
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AMT/Balance Distribution
20905 Torrence Chapel Road
Suite #204
Cornelius, NC 28031
Dean Viktora, CEO
AMT/Balance Distribution
9815-J Sam Furr Road
#230
Huntersville, NC 28078
Rashid Buttar, DO
19620 West Catawba Avenue
Suite 100
Cornelius, NC 28031
Page Last Updated: 05/20/2013
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Links on this page:
1. https://www.transd.com/growth-Hormone-IGF-1-cancer.php
2. http://www.drbuttar.com/patient-resources.html
3. http://www.drbuttar.com/patient-resources.html
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm352633.htm
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