Inspections, Compliance, Enforcement, and Criminal Investigations

Iso-Tex Diagnostics, Inc 3/2/15

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Center for Drug Evaluation and Research
Silver Spring, MD 20993-0002 

 

WARNING LETTER
March 2, 2015
 
Thomas J. Maloney, President
Iso-Tex Diagnostics, Inc.
1511 Country Road 129
Friendswood, TX 77546
 
Dear Mr. Maloney:
 
This letter is in reference to your firm’s manufacturing and marketing of a misbranded and unapproved new drug, Volumex (Albumin Iodinated I-131 Serum) 0.025 mCi/mL, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). 
 
Although FDA has approved Megatope (Albumin Iodinated I-131 Serum) 1 mCi/mL under NDA 017837, we are not aware of an approved application or supplemental application for Volumex 0.025 mCi/mL, which has a different strength from the FDA-approved product.  Manufacturing and marketing this product or other new drugs without an approved application violates the Act.
 
The labeling of this product provides that it is “indicated for use in determinations of total blood and plasma volumes and in protein turnover studies.”  Additionally, under the Precautions Section, it states that “radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.”  As labeled, this product is a drug within the meaning of Section 201(g)(1)(B) and (C) of the Act [21 U.S.C. §§ 321(g)(1)(B) and (C)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body of man or other animals.  Further, this drug product, as manufactured by your firm, is a “new drug” within the meaning of Section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for its 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 it is the subject of an application approved by FDA under either Section 505(b) or (j) of the Act [21 U.S.C. § 355(b) or (j)]. 
 
Additionally, because the above product is a prescription drug within the meaning of Section 503(b)(1) of the Act [21 U.S.C. § 353(b)(1)], adequate directions cannot be written so that a layman can use these products safely for their intended uses.  See 21 CFR § 201.5. Consequently, its labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under Section 502(f)(l) of the Act [21 U.S.C. § 352(f)(1)]. Because your product lacks the required approved application, it is not exempt under 21 CFR § 201.115 from the requirements of Section 502(f)(1) of the Act. The introduction or delivery for introduction into interstate commerce of this misbranded product therefore violates Section 301(a) of the Act [21 U.S.C. § 331(a)].
 
The violations cited in this letter are not intended to be an all-inclusive list of the violations.  You are responsible for (1) investigating and determining the causes of the violations identified above; (2) preventing their recurrence or the occurrence of other violations; and (3) assuring that your firm complies with all requirements of Federal law and FDA regulations.
 
Moreover, you have incurred user fee obligations pursuant to Section 736(a) of the Act [21 U.S.C. § 379h(a)] that remain outstanding. As a result, Section 736(e) of the Act [21 U.S.C. § 379h(e)] precludes FDA from accepting for filing human drug applications submitted by you or your affiliates until all outstanding fees have been paid. The obligations will be treated as a claim of the United States Government, and will accrue fees and interest until satisfied in full. See Section 736(h) of the Act [21 U.S.C. § 379h(h).]
 
You should take prompt action to correct the violations cited in this letter. Within fifteen working days of receipt of this letter, please notify this office in writing whether you plan to cease the violative activities described in this letter. Indicate:
  • whether you no longer manufacture the products referenced in this letter;
  • the reasons for, and the date on which, you ceased manufacture; 
  • the name and address of any other manufacturer, supplier, or distributor of the product that you are aware of;
  • your progress updating FDA’s Drug Registration and Listing System in accordance with 21 CFR 207.30(a)(2). See (http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm); and
  • whether you have paid your overdue user fee payments.
 
Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. If you do not believe that your marketing of the product cited in this letter is in violation of the Act, please include your reasoning and any supporting information for our consideration.
 
Your written response should be sent to the following address: 
 
LCDR Judy Park, Pharm.D.
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Compliance
Office of Unapproved Drugs and Labeling Compliance
Prescription Drugs Branch
Regulatory Status and Labeling Team
Building 51, Room 5162
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
 
Please send an additional desk copy of your written response to the following address:
 
Libero Marzella, M.D., Ph.D.
Food and Drug Administration
Center for Drug Evaluation and Research
Office of New Drugs
Division of Medical Imaging Products
5901-B Ammendale Road
Beltsville, MD 20705-1266
 
If you have any questions about the content of this letter, please contact LCDR Judy Park at (301) 796-2265.
 
Sincerely,
/S/
Kalah Auchincloss, J.D., M.P.H.
Director (acting)
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance

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