IDO Pharm Co., Ltd. — FDA Warning Letter, 2026-05-04: CGMP/OTC Finished Pharmaceuticals/Adulterated
Letter issued · posted to fda.gov .
Subject as published: CGMP/OTC Finished Pharmaceuticals/Adulterated
TL;DR
At a glance: FDA issued a Warning Letter to IDO Pharm Co., Ltd. on 2026-05-04 citing: CGMP/OTC Finished Pharmaceuticals/Adulterated. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ido-pharm-co-ltd-723449-05042026
Argus analysis
IDO Pharm Co., Ltd. (MARCS-CMS 723449) received an FDA Warning Letter dated May 4, 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 12, 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 IDO Pharm Co., Ltd. MARCS-CMS 723449 — May 04, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Electronic Mail - Return Receipt Requested Reference #: 320-26-74 Product: Drugs Recipient: Recipient Name Mr. Young Joo Kim Recipient Title Chief Executive Officer IDO Pharm Co., Ltd. 41 Beonnyeong-ro, 15 beon-gil Danwon-gu Ansan-si Gyeonggi-do 15616 South Korea Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-74 May 4, 2026 Dear Mr. Kim: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, IDO Pharm Co., Ltd., 3017021001, at 41 Beonnyeong-ro, 15 beon-gil, Danwon-gu District, Ansan-si, Gyeonggi-do, from November 10 to 13, 2025. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding 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). We reviewed your December 4, 2025, response to our Form FDA 483 in detail. During our inspection, our investigator observed specific violations including, but not limited to, the following. 1. Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). You manufacture multiple drug products labelled as (b)(4) . Inadequate (b)(4) System Validation Your firm did not establish procedures describing the operation, cleaning, maintenance, or validation of your (b)(4) system, which is used to make a component of your drug products. Hoses were observed to contain stagnant (b)(4) , and your (b)(4) tank contained visible particulate matter floating on the (b)(4) surface, including what appeared to be an insect. In your response, you state that you conducted an immediate inspection of the insanitary conditions in your (b)(4) system, storage tanks, piping, and hoses, and took corrective actions including draining and drying the hose containing stagnant (b)(4) . You state that you will establish a (b)(4) system procedure that includes cleaning frequency for tanks, draining and drying criteria for hoses, and controls to prevent stagnant (b)(4) . You also state you will conduct personnel training. Your response is inadequate because your firm continues to manufacture drug products using an unqualified (b)(4) system that has not been validated for its intended use. You also failed to address the lack of qualification and validation of your (b)(4) system. Inadequate Process and Equipment Clea…
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 IDO Pharm Co., Ltd. had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for IDO Pharm Co., Ltd. as of 2026-05-12. Argus ingests new FDA enforcement records daily.
- What FDA violations was IDO Pharm Co., Ltd. cited for?
- The FDA Warning Letter to IDO Pharm Co., Ltd. (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). IDO Pharm Co., Ltd. — FDA Warning Letter, 2026-05-04: CGMP/OTC Finished Pharmaceuticals/Adulterated. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-ido-pharm-co-ltd-2026-05-04-cgmp
"IDO Pharm Co., Ltd. — FDA Warning Letter, 2026-05-04: CGMP/OTC Finished Pharmaceuticals/Adulterated." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-ido-pharm-co-ltd-2026-05-04-cgmp.
Argus HQ Research. "IDO Pharm Co., Ltd. — FDA Warning Letter, 2026-05-04: CGMP/OTC Finished Pharmaceuticals/Adulterated." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-ido-pharm-co-ltd-2026-05-04-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_ido_pharm_co_ltd_2026_05_04_cgmp_2026,
title = {IDO Pharm Co., Ltd. — FDA Warning Letter, 2026-05-04: CGMP/OTC Finished Pharmaceuticals/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-ido-pharm-co-ltd-2026-05-04-cgmp},
note = {Accessed: July 13, 2026}
}