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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Upspring, Ltd 4/6/12

  

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

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

 

WARNING LETTER
 
APR 6, 2012
Ms. Julie Jumonville
Chief Product Officer
UpSpring, Ltd
8627 N. Mopac Expressway #150
Austin, Texas 78759
 
Dear Ms. Jumonville:
 
This is an amended letter to the one issued on April 4, 2012. 
The Food and Drug Administration (FDA) has learned that your firm is marketing the Milkscreen Home Test for Alcohol in Breast Milk (Milkscreen Test) 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), the Milkscreen Test 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 to affect the structure or function of the body.
 
This device 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g).  The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm 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) 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/cdrh/devadvice/3122.html.  The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
 
(b)(4).  Your firm submitted a new 510(k) application in November 2010. This 510(k) was deleted from our system after 180 manufacturer days when your firm failed to respond to FDA’s request for additional information (hold) letter. As a result, your device does not have any marketing approval or clearance. It is a violation of the law to offer your device for sale without prior FDA marketing clearance.  
 
Your firm should take prompt action to correct the violations addressed in this 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 civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.  
 
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 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:
 
James L. Woods, W066, Office 5688
Deputy Director
Patient Safety and Product Quality
Office of Invitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring, MD 20993 
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility.  It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.  Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance. 
 
                                                                       
Sincerely yours,
/S/ 
Alberto Gutierrez, PhD
Director
Office of In-Vitro Diagnostics
    Evaluation and Safety
Center for Devices and Radiological Health