FDA WARNING_LETTER - Upspring, Ltd

On April 6, 2012, the FDA issued an amended Warning Letter to UpSpring, Ltd., regarding the unauthorized marketing of its Milkscreen Home Test for Alcohol in Breast Milk (Milkscreen Test) in the United States. The FDA determined the Milkscreen Test is a device under section 201(h) of the Act.

The device is adulterated under section 501(f)(1)(B) of the Act because UpSpring, Ltd. lacks an approved premarket approval (PMA) application or an approved investigational device exemption. It is also misbranded under section 502(o) of the Act because the firm failed to provide the required 510(k) premarket notification. A 510(k) application submitted in November 2010 was deleted from the FDA system after 180 manufacturer days due to the firm's failure to respond to a request for additional information.

UpSpring, Ltd. must take prompt action to correct these violations. Failure to comply may result in regulatory actions, including seizure, injunction, civil money penalties, and potential impact on federal contracts. The firm must respond in writing within fifteen business days, detailing specific corrective steps, a plan to prevent recurrence, and a timetable for implementation if corrections extend beyond fifteen days. The response should be sent to James L. Woods at the specified FDA address. This letter is not an exhaustive