- Medical Supply Liquidators Llc
- Issuing Office:
- Kansas City District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
8050 Marshall Drive, Suite 205
Lenexa, Kansas 66214
Telephone: (913) 495-5100
Ref: CMS# 434012
Scott W. Twaddle, Owner/Officer
Medical Supply Liquidators LLC
210 South Prairie View Drive, # 612
West Des Moines, Iowa 50266
Dear Mr. Twaddle:
On June 10 through June 19, 2014, United States Food and Drug Administration (FDA) investigators conducted an inspection of your facility located at 10500 Hickman Road, Suite F, Clive, Iowa 50325. During this inspection, our investigators documented the presence of various drug products such as injectable Vitamin B12. Our investigators also documented the presence of various medical devices such as needles, syringes, and needle-syringe combinations, labelled "Rx Only''.
Based on the information collected during the
inspection at your faci
lity, you distribute unapproved new
drugs in violation of sections
1(d) and 505(a)
of the Fede
Drug, and Cosmeti
c Act (the Act) [21 U.S.C.
(d) and 355(a)]. Furthermore, by
g misbranded drugs into
interstate commerce, you are in
lation of sect
of the Act [21 U.S.C.
You can find the Act
tions from links on FD
age at www.fda.gov.
Based on the information collected during the inspection, you distribute the following prescription drugs, including but not limited to the products listed below:
• Vitamin B12 Cyanocobalamin injection USP 1000 mcg/mL, 10mL and 30mL vials
• Vitamin B12 Methylcobalamin injection USP1000 mcg/mL, 10 mL and 30mL vials
As labeled, the above products are drugs 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 they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and because they are intended to affect the structure or function of the body. Further, these drugs, as marketed by your firm, 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 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 into or delivered for introduction into interstate commerce unless an application approved by FDA under either section 505(b) or (j) of the Act (21 U.S.C. § 355(b) or (j)) is in effect for the drug. There are no FDA-approved application(s) on file for the drugs listed above. The marketing of these drugs or other applicable drugs without an approved application constitutes a violation of these provisions of the Act.
Because the above drugs are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use them safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. Because your drugs lack a required approved application, they are 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 these drugs therefore violates section 301 (a) of the Act [21 U.S.C. § 331(a)].
You should discontinue distributing all of your unapproved drugsat all facilities immediately. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending new drug applications listing your facility as a distributor until the above violations are corrected. Are inspection maybe necessary.
FDA has also determined that your firm was selling and marketing the Oasis (MVI) 3 cc Leur Lock syringe without clearance or approval. Therefore, the Oasis (MVI) 3 cc Luer Lock syringe is adulterated under section 501 (f)(1)(B) of the Act [21 U.S.C.§351 (f)(1)(B)], because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act [21 U.S.C. § 360e(a)], or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act [21 U.S.C. § 360j(g)]. The Oasis (MVI) 3cc Luer Lock syringe is also misbranded under section 502(o) of the Act [21 U.S.C. § 352(o)], because you did not notify the Agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act [21 U.S.C. § 360(k)]. For a device requiring premarket approval, the notification required by section 510(k) of the Act [21 U.S.C. § 360(k)] is deemed satisfied when a PMA is pending before the Agency. 21 CFR 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
Additionally, FDA has determined that your firm is marketing and selling the Dual Channel Tens -7000 5 mode device which is restricted to sale by or on the order of a health care practitioner as well as prescription needles and syringes, including but may not be limited to: Terumo Disposable Hypodermic Needle, BD Single use Hypodermic Syringe, Exelient Disposable Syringes and Hypodermic Needles, Nipro Disposable Syringe with or without Needle, and Oasis (MVI) 3 cc Leur Lock syringe to end users without a prescription. We are aware that the State of Iowa issued Notification to Cease and Desist letters that found your firm to be illegally distributing and dispensing prescription-only medical devices and drugs through its website www.medicalsupplyliquidators.com. The shipping of prescription devices and/or drugs violates Iowa state law because your firm does not have a wholesale drug or pharmacy license, nor does it have any licensed practitioners that would be authorized to receive such prescription devices and/or drugs.
Therefore the prescription devices that you are offering for sale are misbranded under section 502(f)(1) [21 U.S.C. § 352(f)(1)], in that the labeling for these devices fail to bear adequate directions for use for the purposes for which it is intended.
You should immediately cease activities that result in the misbranding or adulteration of the devices discussed above.
Your firm should take prompt action to correct the violations addressed in this Warning Letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your response should be comprehensive and address all violations included in this Warning Letter.
Your response should be sent to: Amy E. Devine, Compliance Officer, U.S. Food and Drug Administration, Kansas City District, 8050 Marshall Drive, Suite 205, Lenexa, Kansas 66214-1524. Please refer to CMS# 434012 when replying. If you have any questions about the contents of this letter, please contact Compliance Officer Devine at the above address or at 913-495-5147.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with all applicable laws and regulations administered by FDA.
Cheryl A. Bigham
Kansas City District