Inspections, Compliance, Enforcement, and Criminal Investigations

Dr. Hettie Morgan 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. Hettie Morgan
5136 Chateau Dr.
San Diego, California 92117

Email address: (b)(4) (b)(6)
888-319-4283

www.hydrigelinjections.com

Re: lnterfall Hydrogel Injection (Polyacrylamide)
Refer to CMS 460239

Dear Dr. Morgan:

The United States Food and Drug Administration (FDA) has learned that your firm is marketing the lnterfall Hydrogel Injection, which is composed of 100% Polyacrylamide, 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), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body.

The FDA has reviewed your firm's website, www.hydrigelinjections.com, and determined that lnterfall Hydrogel Injection is being marketed as a soft tissue filler for use "in the face, lips, and buttocks to increase their size and make them more aesthetically pleasing," and for breast, genital, and whole body shaping.

A review of our records reveals that your firm has not received clearance or approval before offering its device for sale in the US, which is a violation of the law. Therefore, the lnterfall Hydrogel Injection is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does 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 device is 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 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 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 the device is described on the Internet at: http://www.fda.gov/MedicalDevices/DeviceRequlationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

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 460239 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:
Dr. Hettie Morgan
3875 Seven Trees Blvd., I-205
San Jose, CA 95111
 

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