Inspections, Compliance, Enforcement, and Criminal Investigations

Genus Medical Technologies 5/2/17

 

  

Black HHS-Blue FDA Logo

 

 

 
U.S. Food and Drug Administration
Kansas City District Office
8050 Marshall Drive – Suite 205
Lenexa, KS 66214
(913) 495-5100 



May 2, 2017

WARNING LETTER

DELIVERY VIA UPS
REF: CMS Case 506486

Mr. John E. Powers
President and Chief Executive Officer
Genus Medical Technologies, LLC
207 Chesterfield Towne Center
Chesterfield, Missouri 63005

Dear Mr. Powers:

From June 6 through June 8, 2016, investigators from the U.S. Food and Drug Administration (the FDA or the Agency) conducted an inspection of your own-label distribution facility, Genus Medical Technologies, LLC (“Genus” or “your firm”), located at 207 Chesterfield Towne Center, Chesterfield, Missouri 63005.

The inspection revealed that your firm causes the introduction or delivery for introduction into interstate commerce of unapproved new drugs—Vanilla SilQ Barium Sulfate Liquid Suspension, and Vanilla SilQ MD Barium Sulfate Powder for Suspension, both for use as contrast agents for radiographic studies—in violation of Sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act (the “FD&C Act” or “the Act”) [21 U.S.C. §§ 331(d) and 355(a)]. Other sponsors have obtained FDA approval for their barium sulfate oral suspension products for use as contrast agents in radiographic studies. Marketing unapproved barium sulfate products for such use, particularly in direct competition with the approved products, undermines the drug approval system, which is designed to prevent patients from being exposed to the risks associated with potentially unsafe, ineffective, and fraudulent drugs.


Furthermore, these drugs are misbranded under section 502 of the FD&C Act [21 U.S.C. § 352], and by causing the introduction or delivery for introduction of these products into interstate commerce, you are in violation of section 301(a) of the FD&C Act [21 U.S.C. §§ 331(a)]. This violation is concerning from a public health perspective because the labeling of the drugs you introduced into interstate commerce provides neither adequate directions for safe and effective use nor adequate warnings for such use.

Unapproved New Drug Violations

Based on labeling and other information collected during the inspection, you market the following prescription drugs, including but not limited to:

  • Vanilla SilQ Barium Sulfate Liquid Suspension 2.1% w/v 2.0% w/w (NDC 69307-1024), for use as a contrast agent in radiographic studies for oral and rectal administration; and
  • Vanilla SilQ MD Barium Sulfate Powder for Suspension 96 % w/w (NDC 69307-4096), for use as a contrast agent for radiographic studies for oral and rectal administration.

Both Vanilla SilQ and Vanilla SilQ MD, which are intended for use as contrast agents in radiographic studies, are drugs within the meaning of section 201(g)(1) of the Act [21 U.S.C. 321(g)(1)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans. Further, both products are “new drugs” within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Moreover, consistent with our letter to you dated January 5, 2016, we remain unpersuaded by the documentation submitted by your firm on September 25, 2015 purporting to establish that your products are “grandfathered” under section 201(p)(1). FDA’s criteria for determining “grandfather” status of a drug product includes establishing whether the specific product at issue being marketed today has the same formulation, strength, dosage form, routes of administration, indication, intended patient populations, and other conditions of use as a drug product marketed between January 1, 1907 and June 25, 1938. As stated in FDA’s January 5, 2016 letter, for FDA to determine “grandfather” status, a firm must provide copies of the product labeling that is shown to be from the period from January 1, 1907 and June 25, 1938, and this labeling must be the same as the labeling used today. You have not provided historic labeling for your product, leaving FDA unable to determine if your barium sulfate drug products qualify for the grandfather exemption. Accordingly, FDA does not consider your products “grandfathered” under section 201(p)(1), and as such, FDA does not consider your products exempt from “new drug” status.

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 application filed with FDA under section 505(b) or (j) of the Act [21 U.S.C. § 355(b) and (j)] is effective with respect to such drug. Based on our information, there are no FDA-approved applications on file for either of these drugs. The introduction or delivery for introduction (or the causing thereof) into interstate commerce of a new drug in violation of section 505 is prohibited under 301(d) of the Act [21 U.S.C. § 331(d)].

Misbranding Violations

Section 301(a) of the Act [21 U.S.C. § 331(a)] prohibits the introduction or delivery for introduction (or the causing thereof) into interstate commerce of a misbranded drug.
Genus Medical Technologies LLC Warning Letter FEI: 3011028213
Chesterfield, MO CMS Case: 506486

A drug is deemed to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. Under 21 CFR 201.5, “adequate directions for use” means directions under which a layman can use the drug safely and for the purposes for which it is intended. “Prescription drugs,” as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], are drugs that, because of their toxicity or potential for harmful effect, method of use, or collateral measures necessary to their use, are not safe for use except under the supervision of a practitioner licensed by law to administer them. Accordingly, adequate directions cannot be written for prescription drugs so that a layman can use them safely for their intended uses.

Due to the toxicity and other potential for harmful effect and the collateral measures necessary to their use, Vanilla SilQ and Vanilla SilQ MD are not safe for use except under the supervision of a licensed practitioner. In addition, Vanilla SilQ and Vanilla SilQ MD are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. For these reasons, they are prescription drugs as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], and adequate directions cannot be written so that a layman can use them safely for their intended uses. Consequently, the labeling of these drugs fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(l) of the Act [21 U.S.C. § 352(f)(1)].

Additionally, a drug is deemed to be misbranded under section 502(f)(2) of the Act [21 U.S.C. § 352(f)(2)] if its labeling fails to bear “adequate warnings against use in those pathological conditions . . . or application, in such manner and form, as are necessary for the protection of users . . . .” We note that FDA has reviewed and approved barium sulfate oral suspension drug products (NDA 208036 and NDA 208143) and determined that such products require warning information pursuant to 21 C.F.R. 201.57. This warning information includes the need to have emergency equipment and personnel immediately available and that intra-abdominal leakage may occur in certain conditions, such as GI fistula, ulcer, inflammatory bowel disease, appendicitis or diverticulitis, severe stenosis or obstructing lesions of the GI tract. Further, given these serious risks, it is especially concerning that the labeling of these products describe an additional rectal route of administration and similarly fails to provide adequate warnings for such use. The failure of Vanilla SilQ and Vanilla SilQ MD to include adequate warnings renders them misbranded under section 502(f)(2) of the FD&C Act [21 U.S.C. 352(f)(2)].

Further, a drug is deemed to be misbranded under section 502(a) of the Act [21 U.S.C. 352(a)] 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 an article’s labeling “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 materials in light of such representations.” The labels collected by the FDA investigators for both Vanilla SilQ and Vanilla SilQ MD misleadingly state that the products are manufactured by Genus Medical Technologies, when in fact the products are manufactured by (b)(4). Further, Vanilla SilQ and Vanilla SilQ MD are also misbranded because their labeling misleadingly fails to reveal material facts with respect to consequences that may result from the use of these products. As described above, barium sulfate oral suspension products may pose serious health risks to consumers. Furthermore, the expression of the net contents in two distinct measurements (w/v and w/w) in Vanilla SilQ’s label as described above may confuse practitioners about the strength of the product, rendering the labeling misleading.

Conclusion

The 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. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter by discontinuing the manufacturing and distribution of all of your unapproved drugs immediately, if you have not done so already. 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. Additionally, FDA may withhold approval of requests for export certificates or approval of pending new drug applications until the above violations are corrected. A re-inspection may be necessary to verify corrective actions have been completed.

FDA requests that you contact CDER’s Drug Shortages Staff immediately at drugshortages@fda.hhs.gov so that we can work with you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture, as required under 21 U.S.C. § 356c(a), and to allow FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.
 

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations. Your response should include an explanation of each step that has been taken or will be taken to correct the violations and prevent their recurrence. 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. Please include copies of any documentation demonstrating that corrections have been made. If you no longer distribute barium sulfate products, your response should indicate that, including the reasons that and the date on which you ceased production.

All firms are required to electronically update the listing of their products under section 510(j) of the FD&C Act to reflect discontinuation of the manufacture, repacking, relabeling, or salvaging for commercial distribution of a listed drug [21 CFR 207.57(b)]. Questions about electronic drug listing updates should be sent to eDRLS@fda.hhs.gov. In addition to the required update, firms can also notify the FDA of product discontinuation by sending a letter, signed by the firm’s chief executive officer and fully identifying the discontinued products, including the product NDC number, and stating that the manufacturing and/or distribution of the products have been discontinued. FDA plans to rely on its existing records, including its drug listing records, the results of any future inspections, or other available information when considering enforcement action.

Send your electronic reply to Miguel.Hernandez@fda.hhs.gov or mail your reply to:

Miguel Hernandez
Compliance Branch Director
U.S. Food and Drug Administration
Kansas City District Office
8050 Marshall Drive, Suite 205
Lenexa, Kansas 66214

Please identify your response with FEI: 3011028213

Sincerely,
/s/
Cheryl A. Bigham
District Director
Kansas City District
Genus Medical Technologies LLC Warning Letter FEI: 3011028213
Chesterfield, MO CMS Case: 506486
 

Page Last Updated: 05/30/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English