FDA WARNING_LETTER - Induction Therapies, LLC - June 29, 2021

The FDA issued a Warning Letter to Induction Therapies, LLC, on November 23, 2021, following an inspection from June 15-29, 2021, at their Louisville, KY facility. The inspection determined the firm manufactures Collagen P.I.N., a microneedling product identified as a medical device under section 201(h) of the Act.

The FDA's review of product labeling, including brochures, pamphlets, and the firm's website (Inductiontherapies.com), revealed the Collagen P.I.N. is intended for various medical applications, such as skin rejuvenation, treating acne scarring, rhytides, surgical scars, dyschromia, melasma, enlarged pores, and transdermal drug delivery.

The Collagen P.I.N. is being sold and distributed in the U.S. without required marketing approval, clearance, or authorization from the FDA. This renders the device adulterated under section 501(f)(1)(B) of the Act, as the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE). Additionally, the device is misbranded under section 502(o) of the Act because the firm failed to notify the FDA of its intent to introduce the device into commercial distribution, as required by section 510(k).

The FDA prohibits the introduction or delivery