Inspections, Compliance, Enforcement, and Criminal Investigations

Dr. Ashley Minas 5/29/15

  

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

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993

WARNING LETTER

May 29, 2015

Dr. Ashley Minas
Minasian Medical Centre
No 31 Adranik Street
Meghri Town, Sunik
377910 Armenia

Email address: (b)(4) (b)(6)
+347.1473336

www.consultdrminas.com

Re: lnterfall Hydrogel (100% Polyacrylamide) and Teosyal (Hyaluronic Acid) Products
Refer to CMS# 460244

Dear Dr. Minas:

The United States Food and Drug Administration (FDA) has learned that your firm is marketing lnterfall Hydrogel products, which are composed of 100% Polyacrylamide, and Teosyal products, which are composed of cross-linked and non-cross linked Hyaluronic Acid, in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

Under section 201(h) of the Act, 21 U.S.C.§ 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or any function of the body.

The FDA has reviewed the website, www.consultdrminas.com. and determined that lnterfall Hydrogel products are being marketed as a dermal filler for shaping the face, genitals, mammary glands, and buttocks; elimination of deep deforming scars; and endoprosthetics of vocal chords in cases of paralytic stenosis of the larynx, as well as for a number of other indications. Additionally, Teosyal is being marketed as an aesthetic medicine which is "among the top 3 fillers in the world today. "

A review of our records reveals that your firm has not received clearance or approval before offering its devices for sale in the US, which is a violation of the law. Therefore, the lnterfall Hydrogel and Teosyal products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C.§ 360j(g). The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce these devices 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 is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b) The kind of information that your firm needs to submit in order to obtain approval or clearance for these devices is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the products may be legally marketed.

Given the serious nature of the violations of the Act, the lnterfall Hydrogel and Teosyal products marketed by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention. your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter.

Please notify this office in writing within fifteen (15) 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 your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. 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 firm's response should be comprehensive and address all violations included in this Warning Letter.

Your firm's response should be sent to:

Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Field Inspections Support Branch
White Oak Building 66, Rm 2609
10903 New Hampshire Ave.
Silver Spring, MD 20993

Refer to the identification number CMS 460244 when replying. We remind you that only written communication is considered official. If you have any questions about the contents of this letter, please contact: LaShanda M. Long at 1-301-796-5465 or 1-301-847-8137 (fax).

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm's responsibility to ensure compliance with the applicable laws and regulations administered by FDA.
 

Sincerely yours,
/S/
Jan B. Welch, MHS, MT (ASCP) SBB
Acting Director
Office of Compliance
Center for Devices and
     Radiological Health

CC:
Minasian Medical Centre,
43 Moldovakan str.,
Nork Massiv II,
Yerevan,
Republic of Armenia (CIS),
Postal Code: 375062
 

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