FDA Cites InvaDerm, Inc. in 2026-06-03 Warning Letter — Electronic Drug Registration and Listing System (eDRLS)/Violations
Letter issued · posted to fda.gov .
Subject as published: Electronic Drug Registration and Listing System (eDRLS)/Violations
TL;DR
At a glance: FDA's Center for Drug Evaluation and Research (CDER) issued a Warning Letter to InvaDerm, Inc. on 2026-06-03 regarding Electronic Drug Registration and Listing System (eDRLS)/Violations. The letter references 21 CFR 201.128. The verbatim letter is published on fda.gov.
Argus analysis
InvaDerm, Inc. received a Warning Letter from FDA's Center for Drug Evaluation and Research (CDER), dated 2026-06-03, regarding Electronic Drug Registration and Listing System (eDRLS)/Violations. The letter follows an FDA inspection and is classified by Argus HQ as critical severity, consistent with the matters detailed in the letter body below.
The published letter cites 21 CFR 201.128. Warning Letters citing these sections generally concern the matters detailed in the letter body below. The full citation language and supporting observations are in the verbatim letter linked below — Argus HQ does not add citations beyond what FDA published.
FDA Warning Letters carry a 15-business-day response window for the recipient to detail corrective actions. Peer compliance teams in the same product category typically use a letter like this one as an external audit trigger, checking whether their own quality system has documented coverage for the cited sections and whether their CAPA log would withstand the same line of inspection questioning.
Severity context
Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
Regulatory background
FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER InvaDerm, Inc. MARCS-CMS 713177 — June 03, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Dilip Solanki Recipient Title CEO InvaDerm, Inc. 25 Worlds Fair Drive Somerset , NJ 08873-1344 United States dilip.solanki@inva-derm.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER June 3, 2026 RE: CMS 713177 Dear Mr. Solanki: 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). Unapproved New Drug Violations 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 produ…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- What is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
- Has InvaDerm, Inc. had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for InvaDerm, Inc. as of 2026-06-16. Argus ingests new FDA enforcement records daily.
- What FDA violations was InvaDerm, Inc. cited for?
- The FDA Warning Letter to InvaDerm, Inc. (issuing office: Center for Drug Evaluation and Research (CDER)) cites: Electronic Drug Registration and Listing System (eDRLS)/Violations. Classification: Warning Letter.
- When did FDA issue the warning letter to InvaDerm, Inc.?
- FDA issued the letter (MARCS-CMS 713177) on 2026-06-03 and posted it publicly on fda.gov on 2026-06-16.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Cites InvaDerm, Inc. in 2026-06-03 Warning Letter — Electronic Drug Registration and Listing System (eDRLS)/Violations. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-invaderm-inc-2026-06-03-warning-letter
"FDA Cites InvaDerm, Inc. in 2026-06-03 Warning Letter — Electronic Drug Registration and Listing System (eDRLS)/Violations." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-invaderm-inc-2026-06-03-warning-letter.
Argus HQ Research. "FDA Cites InvaDerm, Inc. in 2026-06-03 Warning Letter — Electronic Drug Registration and Listing System (eDRLS)/Violations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-invaderm-inc-2026-06-03-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_invaderm_inc_2026_06_03_warning_letter_2026,
title = {FDA Cites InvaDerm, Inc. in 2026-06-03 Warning Letter — Electronic Drug Registration and Listing System (eDRLS)/Violations},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-invaderm-inc-2026-06-03-warning-letter},
note = {Accessed: July 13, 2026}
}