FDA WARNING_LETTER - InvaDerm, Inc. - October 17, 2024

InvaDerm, Inc., located in Somerset, New Jersey, received an FDA warning letter following an inspection conducted from October 15 to 17, 2024. The letter, issued on June 3, 2026, identifies major regulatory violations regarding the company"s distribution of unapproved new drugs. According to the FDA, InvaDerm is responsible for introducing products into the U.S. market that are intended for medical use—such as diagnosing or treating diseases—but lack the required federal approval. Under the regulatory framework of the Federal Food, Drug, and Cosmetic (FD&C) Act, these products are considered "new drugs" and cannot be legally sold without an approved application confirming their safety and effectiveness. To reach compliance, the FDA requires InvaDerm to immediately cease the marketing of all unapproved prescription drugs manufactured at its facility. The company must investigate the root causes of these violations and implement corrective measures to prevent future occurrences. InvaDerm is required to submit a written response within 15 working days detailing their plan for compliance, including documentation of any corrective actions and updates to their electronic drug registration files. Failure to rectify these issues promptly may lead to legal consequences, including product seizures, injunctions, or the withholding of export certificates.