FDA Warning Letter to Respilon Production S.R.O. (2026-04-20) — 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 issued a Warning Letter to Respilon Production S.R.O. on 2026-04-20 citing: CGMP/OTC/Finished Pharmaceuticals/Adulterated. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/respilon-production-sro-719705-04202026
Argus analysis
Respilon Production S.R.O. (MARCS-CMS 719705, FEI 3018892481) received an FDA Warning Letter dated April 20, 2026 from the Center for Drug Evaluation and Research (CDER). The letter cites: CGMP/OTC/Finished Pharmaceuticals/Adulterated. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on May 5, 2026.
Nonprescription/OTC letters typically cite the relevant OTC monograph under 21 CFR Part 330 (or the newer OTC monograph order process under the CARES Act) alongside 21 USC 352 misbranding provisions. Common findings involve active ingredients, dosing, or labeling claims that fall outside the applicable monograph's permitted conditions.
FDA Warning Letters typically specify a 15-working-day response window for the recipient to detail corrective actions. Compliance teams at peer companies in the same CGMP (Current Good Manufacturing Practice) category commonly use a newly published letter as a prompt to re-check their own procedures against the same citation, and to watch fda.gov for a close-out letter confirming the cited firm's corrective action was accepted — or, absent one, for escalation to import alert, injunction, or product seizure.
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 Respilon Production S.R.O. MARCS-CMS 719705 — April 20, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Reference #: 320-26-69 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Roman Zima Recipient Title Chief Executive Officer Respilon Production S.R.O. Prikop 843/4 Brno 602 00 Jihomoravsky Czechia Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-69 April 20, 2026 Dear Mr. Zima: 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 May 2, 2025, request and subsequent correspondence, 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, Respilon Production S.R.O, FEI 3018892481, at Prikop 843/4, Brno, Jihomoravsky, Czech Republic. 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 our review of records and other information you 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 conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)). Your response to our request for records under section 704(a)(4) indicated that you do not test the identity of each incoming component used in the manufacture of your drug products, such as (b)(4) , before manufacturing. In addition, you failed to test each shipment of (b)(4) for (b)(4) contamination before use. Identity testing for (b)(4) and certain other high-risk drug components includes a limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits for levels of (b)(4) . Because you did not perform adequate identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to ensure the acceptability of these components for use in the manufacturing of your drug product. See FDA’s guidance document (b)(4) for help in meeting the CGMP requirements when manufacturing drugs containing ingredients at hi…
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
- Is the FDA warning letter to Respilon Production S.R.O. 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/respilon-production-sro-719705-04202026.
- 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.
- 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.
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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 Warning Letter to Respilon Production S.R.O. (2026-04-20) — CGMP/OTC/Finished Pharmaceuticals/Adulterated. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-respilon-production-s-r-o-2026-04-20-cgmp
"FDA Warning Letter to Respilon Production S.R.O. (2026-04-20) — CGMP/OTC/Finished Pharmaceuticals/Adulterated." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-respilon-production-s-r-o-2026-04-20-cgmp.
Argus HQ Research. "FDA Warning Letter to Respilon Production S.R.O. (2026-04-20) — CGMP/OTC/Finished Pharmaceuticals/Adulterated." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-respilon-production-s-r-o-2026-04-20-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_respilon_production_s_r_o_2026_04_20_cgmp_2026,
title = {FDA Warning Letter to Respilon Production S.R.O. (2026-04-20) — CGMP/OTC/Finished Pharmaceuticals/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-respilon-production-s-r-o-2026-04-20-cgmp},
note = {Accessed: July 13, 2026}
}