InvaDerm, Inc.

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, InvaDerm, Inc. FEI 3010165760, at 25 Worlds Fair Drive, Somerset, NJ, from October 15 – 17, 2024. In addition, following FDA’s 2024 inspection, the Agency reviewed your firm’s products’ drug listings, including the current labeling which you submitted to FDA’s electronic Drug Registration and Listing System (eDRLS) and certified to be current at the time of your latest registration and listing update.

Your firm manufactures and is responsible for introducing or delivering for introduction into interstate commerce in the United States products that are unapproved new drugs in violation of sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. Sections 331(d) and 355(a), including: (b)(4) and (b)(4) and (b)(4) and (b)(4) (hereinafter InvaDerm products) . Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. Section 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. Sections 331(d) and 355(a).

Your InvaDerm products are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. Section 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.

Examples from your product labeling that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:

(b)(4)

Your InvaDerm products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above described conditions prescribed, recommended, or suggested in their labeling.

With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of violations identified above and for preventing their recurrence and the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of Federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal actions without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts. You should discontinue marketing all of the unapproved prescription drugs manufactured at your facility immediately. Additionally, FDA may withhold approval of requests for export certificates or approval of pending new drug applications listing your facility as a manufacturer until the above violations are corrected. A reinspection may be necessary to verify corrective actions have been completed.

Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm’s name and the unique identifier “CMS 713177” in the subject line of the email.