- Delivery Method:
- United Parcel Service
- Medical Devices
Recipient NameAngelia L. Inscoe
- Induction Therapies, LLC
3600 Chamberlain Lane, Ste 336
Louisville, KY 40241
- Issuing Office:
- Center for Devices and Radiological Health
CMS # 616487
November 23, 2021
Dear Ms. Inscoe:
The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at 3600 Chamberlain Lane, Suite 336, Louisville, KY, from June 15 – June 29, 2021. During the inspection, an FDA investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of Collagen P.I.N., a microneedling product. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (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 intended to affect the structure or any function of the body.
The agency has reviewed the product labeling for the Collagen P.I.N, including brochures, pamphlets, and your firm’s website at Inductiontherapies.com. This review revealed statements that establish that the Collagen P.I.N. is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body, including:
• Per your firm’s brochure. “Collagen P.I.N. is a method of (b)(4).”
• Per your firm’s labeling, “Collagen P.I.N. is a Class 1 FDA registered medical device for Percutaneous Collagen Induction Therapy. This device should only be used by or under the supervision of a physician. Supervising Physician ultimately decides all protocols for treatments.”
• Per your firm’s combined labeling “Microneedling has recently been touted for a broad range of applications including skin rejuvenation, acne scarring, rhytides, surgical scars, dyschromia, melasma, enlarged pores, and transdermal drug delivery.”
• Per your firm’s combined labeling, “Microneedling is deemed a safe, minimally invasive and effective esthetic treatment for multiple dermatologic conditions including acne and other scars, rhytides and striae. It is also considered a valuable alternative to more invasive procedures such a laser skin resurfacing and deep chemical peeling.”
• Per your firm’s website, “SKIN CONCERNS - Collagen P.I.N, addresses most major skin concerns Including fine lines and wrinkles, aging, sun damaged skin, peri-oral rhytides. melasma, hyperpigmentation issues, acne scarring and rough texture just to mention a few. With only 3 to 6 treatments you can achieve long-term sustainable results when supported by the Induction Therapies product line.”
Our inspection, review of materials collected during the inspection, and review of your firm’s website, revealed that the Collagen P.I.N. is offered for sale and distributed in the United States without marketing approval, clearance, or authorization from FDA. Accordingly, the Collagen P.I.N. 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 Collagen P.I.N. 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). The introduction or delivery for introduction of this product into interstate commerce is prohibited under section 301(a) of the Act, 21 U.S.C. § 331(a).
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. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been corrected. Also, should FDA determine that your devices do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted. If you believe that your products are not in violation of the Act, please respond to FDA with your reasoning and any supporting information for our consideration.
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 (which must address systemic problems) 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.
If you have questions regarding any issues in this letter, please contact Compliance Officer Sean Moynihan at firstname.lastname@example.org. Please send your reply electronically to Gina Brackett, Director of Compliance Branch, at email@example.com.
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 applicable laws and regulations administered by FDA.
Joseph Matrisciano, Jr.
Program Division Director
Office of Medical Device and Radiological Health
Binita S. Ashar, MD, MBA, FACS
Office of Surgery and Infection Control Devices
Office of Product Quality and Evaluation
Center for Devices and Radiological Health