FDA Cites Alchymars ICM SM Private Limited in 2026-05-21 Warning Letter — CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Letter issued · posted to fda.gov .
Subject as published: CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
TL;DR
FDA issued a Warning Letter to Alchymars ICM SM Private Limited on 2026-05-21 citing: CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/alchymars-icm-sm-private-limited-724429-05212026
Argus analysis
Alchymars ICM SM Private Limited (MARCS-CMS 724429, FEI 3005216842) received an FDA Warning Letter dated May 21, 2026 from the Center for Drug Evaluation and Research (CDER). The letter cites: CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on May 26, 2026.
CGMP citations typically reference 21 CFR Part 211 (finished pharmaceuticals) or Part 111 (dietary supplements), covering subjects such as identity testing of incoming components, validated cleaning procedures, batch-failure investigations, and stability program design. Repeat or systemic findings are what typically drive FDA toward import alert or consent decree escalation.
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 Alchymars ICM SM Private Limited MARCS-CMS 724429 — May 21, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Electronic Mail - Return Receipt Requested Reference #: 320-26-77 Product: Drugs Recipient: Alchymars ICM SM Private Limited A-14 & 20 Sidco Pharmaceutical Complex Alathur 603110 Tamil Nadu India Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-77 May 21, 2026 Dear Mr. Kaliyamoorthy: The United States Food and Drug Administration (FDA) conducted an unannounced inspection of your drug manufacturing facility, Alchymars ICM SM Private Limited, FEI 3005216842, at A-14 & 20 Sidco Pharmaceutical Complex, Alathur, Tamil Nadu, from November 28 to December 4, 2025. This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your APIs 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 26, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. During our inspection, our investigator observed specific deviations including, but not limited to, the following. 1. Failure to ensure that equipment is maintained. Your firm failed to adequately maintain the (b)(4) used to manufacture (b)(4) API for the U.S. market. Our investigator documented (b)(4) in the (b)(4) manufacturing workshop in various levels of disrepair, including cracked, taped, and deteriorating (b)(4) gaskets, rust-like residues on product-contact surfaces such as (b)(4) , and cracked (b)(4) inside one of the (b)(4) . These findings directly contradict your firm’s own cleaning and preventive maintenance records, which had documented the condition of all these (b)(4) as “ok.” Additionally, our investigator observed wet paint on one of your (b)(4) while production activities were ongoing. In your response, you acknowledge the deteriorated condition of your equipment and attributed the deficiencies to inadequacies in your cleaning program and absence of a lifecycle management program for your equipment. You also acknowledge that your inaccurate recordkeeping stemmed from “insufficient inspection rigor.” As corrective action, you have initiated physical repair of all equipment and a complete overhaul of procedures for cleaning, maintenance, inspection, and gasket management. Your response is inadequate because your investigation does not extend to testing residues found in your equipment or retain samples to assess the potential impact on product quality. Furthermore, your response fails to explain the inability of your quality system, despite having numerous checklists and procedures already in place, to identify and …
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 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.
- Has Alchymars ICM SM Private Limited had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Alchymars ICM SM Private Limited as of 2026-05-26. Argus ingests new FDA enforcement records daily.
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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 Alchymars ICM SM Private Limited in 2026-05-21 Warning Letter — CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-alchymars-icm-sm-private-limited-2026-05-21-cgmp
"FDA Cites Alchymars ICM SM Private Limited in 2026-05-21 Warning Letter — CGMP/Active Pharmaceutical Ingredient (API)/Adulterated." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-alchymars-icm-sm-private-limited-2026-05-21-cgmp.
Argus HQ Research. "FDA Cites Alchymars ICM SM Private Limited in 2026-05-21 Warning Letter — CGMP/Active Pharmaceutical Ingredient (API)/Adulterated." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-alchymars-icm-sm-private-limited-2026-05-21-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_alchymars_icm_sm_private_limited_2026_05_21_cgmp_2026,
title = {FDA Cites Alchymars ICM SM Private Limited in 2026-05-21 Warning Letter — CGMP/Active Pharmaceutical Ingredient (API)/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-alchymars-icm-sm-private-limited-2026-05-21-cgmp},
note = {Accessed: July 13, 2026}
}