2026-06-02 FDA Warning Letter: Revlon Group Holdings, LLC Cited for CGMP/OTC Finished Pharmaceuticals/Adulterated
Letter issued · posted to fda.gov .
Subject as published: CGMP/OTC Finished Pharmaceuticals/Adulterated
TL;DR
The short version: FDA's Center for Drug Evaluation and Research (CDER) issued a Warning Letter to Revlon Group Holdings, LLC on 2026-06-02 regarding CGMP/OTC Finished Pharmaceuticals/Adulterated. The letter references 21 CFR 211.84(d)(1), 21 CFR 211.84(d)(2). The verbatim letter is published on fda.gov.
Argus analysis
Revlon Group Holdings, LLC received a Warning Letter from FDA's Center for Drug Evaluation and Research (CDER), dated 2026-06-02, regarding CGMP/OTC Finished Pharmaceuticals/Adulterated. The letter follows an FDA inspection and is classified by Argus HQ as critical severity, consistent with Current Good Manufacturing Practice violations under 21 CFR Part 211 (drugs) or Part 600 (biologics).
The published letter cites 21 CFR 211.84(d)(1), 21 CFR 211.84(d)(2). Warning Letters citing these sections generally concern Current Good Manufacturing Practice violations under 21 CFR Part 211 (drugs) or Part 600 (biologics), typically covering component testing, cleaning validation, laboratory controls, or investigation of out-of-specification results. 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
CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
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 Revlon Group Holdings, LLC MARCS-CMS 722596 — June 02, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS Reference #: 320-26-89 Product: Drugs Recipient: Recipient Name Mr. David Hamilton Recipient Title Vice President of Operations Revlon Group Holdings, LLC 1501 Williamsboro St. Oxford , NC 27565 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-89 June 2, 2026 Dear Mr. Hamilton: Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our September 8, 2025 request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility, Revlon – Oxford Facility, FEI 1021184, at 1501 Williamsboro St., Oxford, as well as subsequent correspondence. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations, parts 210 and 211 (21 CFR, parts 210 and 211). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your response to our 704(a)(4) request do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(B)). Following review of records and other information provided pursuant to section 704(a)(4) of the FD&C Act, significant violation were observed including, but not limited to, the following: 1. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 21 CFR 211.84(d)(2)). Your firm manufactured (b)(4) , an OTC (b)(4) drug product labeled to contain the active drug ingredient (b)(4) . You currently manufacture (b)(4) OTC drug product labeled to contain the active drug ingredient (b)(4) . These drug products listed above are labeled to contain the inactive ingredient talc. Both talc and asbestos are naturally occurring minerals that may be found in close proximity in the earth. Asbestos is a potential contaminant in talc and is a known human carcinogen when inhaled. 1,2 Your (b)(4) drug product, (b)(4) , is considered a higher-risk drug as it pertains to patient safety regarding asbestos contamination of talc due to the risk of inadvertent inhalation. You have not demonstrated that you appropriately tested incoming talc drug components used in the manufacture of your (b)(4) drug products for identity, purity, strength, and quality. In response to our 704(a)(4) request, you originally indicated that you did perform testing for asbestos in talc before release for use in drug product manuf…
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 regulatory background for a CGMP — Current Good Manufacturing Practice warning letter?
- CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
- 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 Revlon Group Holdings, LLC had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Revlon Group Holdings, LLC as of 2026-06-09. Argus ingests new FDA enforcement records daily.
- What FDA violations was Revlon Group Holdings, LLC cited for?
- The FDA Warning Letter to Revlon Group Holdings, LLC (issuing office: Center for Drug Evaluation and Research (CDER)) cites: CGMP/OTC Finished Pharmaceuticals/Adulterated. Classification: CGMP — Current Good Manufacturing Practice.
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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). 2026-06-02 FDA Warning Letter: Revlon Group Holdings, LLC Cited for CGMP/OTC Finished Pharmaceuticals/Adulterated. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-revlon-group-holdings-llc-2026-06-02-cgmp
"2026-06-02 FDA Warning Letter: Revlon Group Holdings, LLC Cited for CGMP/OTC Finished Pharmaceuticals/Adulterated." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-revlon-group-holdings-llc-2026-06-02-cgmp.
Argus HQ Research. "2026-06-02 FDA Warning Letter: Revlon Group Holdings, LLC Cited for CGMP/OTC Finished Pharmaceuticals/Adulterated." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-revlon-group-holdings-llc-2026-06-02-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_revlon_group_holdings_llc_2026_06_02_cgmp_2026,
title = {2026-06-02 FDA Warning Letter: Revlon Group Holdings, LLC Cited for CGMP/OTC Finished Pharmaceuticals/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-revlon-group-holdings-llc-2026-06-02-cgmp},
note = {Accessed: July 13, 2026}
}