Warning Letter Record: Erkul Kozmetik Sanayi ve Ticaret A.S. (2026-06-02) — CGMP/OTC Finished Pharmaceuticals/Adulterated
Letter issued · posted to fda.gov .
Subject as published: CGMP/OTC Finished Pharmaceuticals/Adulterated
TL;DR
Key takeaway: FDA's Center for Drug Evaluation and Research (CDER) issued a Warning Letter to Erkul Kozmetik Sanayi ve Ticaret A.S. 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
Erkul Kozmetik Sanayi ve Ticaret A.S. 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 high 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
High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
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 Erkul Kozmetik Sanayi ve Ticaret A.S. MARCS-CMS 721964 — June 02, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS Reference #: 320-26-85 Product: Drugs Recipient: Recipient Name Ms. Fatma Faize Aktar Recipient Title General Manager Erkul Kozmetik Sanayi ve Ticaret A.S. Cihangir Mahallesi, Petrol Ofisi Caddesi No: 1 Avcilar / İstanbul Turkey Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-85 June 2, 2026 Dear Ms. Aktar: Your facility was 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 August 25, 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, Erkul Kozmetik Sanayi ve Ticaret A.S., FEI 3012641739, at Cihangir Mahallesi, Petrol Ofisi Caddesi No: 1, Avcilar, Istanbul, 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 violations 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 manufactures OTC (b)(4) drug products labeled to contain the active drug ingredient (b)(4) . These drug products are labeled and formulated to contain the inactive ingredient talc. For example, (b)(4) is composed of more than (b)(4) % 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 products containing talc are considered higher-risk drugs as they pertain to patient safety regarding asbestos contamination of talc due to the risk of inadvertent inhalation. You have not demonstrated that you have appropriately tested incoming talc-containing 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 indicate that you did not conduct identity testing on the talc yo…
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 FDA violations was Erkul Kozmetik Sanayi ve Ticaret A.S. cited for?
- The FDA Warning Letter to Erkul Kozmetik Sanayi ve Ticaret A.S. (issuing office: Center for Drug Evaluation and Research (CDER)) cites: CGMP/OTC Finished Pharmaceuticals/Adulterated. Classification: CGMP — Current Good Manufacturing Practice.
- When did FDA issue the warning letter to Erkul Kozmetik Sanayi ve Ticaret A.S.?
- FDA issued the letter (MARCS-CMS 721964) on 2026-06-02 and posted it publicly on fda.gov on 2026-06-09.
- Is the FDA warning letter to Erkul Kozmetik Sanayi ve Ticaret A.S. publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/erkul-kozmetik-sanayi-ve-ticaret-721964-06022026.
- What does a "high" severity rating mean for this letter?
- High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
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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). Warning Letter Record: Erkul Kozmetik Sanayi ve Ticaret A.S. (2026-06-02) — CGMP/OTC Finished Pharmaceuticals/Adulterated. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-erkul-kozmetik-sanayi-ve-ticaret-a-s-2026-06-02-cgmp
"Warning Letter Record: Erkul Kozmetik Sanayi ve Ticaret A.S. (2026-06-02) — CGMP/OTC Finished Pharmaceuticals/Adulterated." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-erkul-kozmetik-sanayi-ve-ticaret-a-s-2026-06-02-cgmp.
Argus HQ Research. "Warning Letter Record: Erkul Kozmetik Sanayi ve Ticaret A.S. (2026-06-02) — CGMP/OTC Finished Pharmaceuticals/Adulterated." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-erkul-kozmetik-sanayi-ve-ticaret-a-s-2026-06-02-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_erkul_kozmetik_sanayi_ve_ticaret_a_s_2026_06_02_cgmp_2026,
title = {Warning Letter Record: Erkul Kozmetik Sanayi ve Ticaret A.S. (2026-06-02) — CGMP/OTC Finished Pharmaceuticals/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-erkul-kozmetik-sanayi-ve-ticaret-a-s-2026-06-02-cgmp},
note = {Accessed: July 13, 2026}
}