Laboratorios Jaloma S.A. de C.V. — FDA Warning Letter, 2026-05-22: CGMP/OTC/Finished Pharmaceuticals/Adulterated
Letter issued · posted to fda.gov .
Subject as published: CGMP/OTC/Finished Pharmaceuticals/Adulterated
TL;DR
Here's the summary: FDA issued a Warning Letter to Laboratorios Jaloma S.A. de C.V. on 2026-05-22 citing: CGMP/OTC/Finished Pharmaceuticals/Adulterated. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/laboratorios-jaloma-sa-de-cv-725939-05222026
Argus analysis
Laboratorios Jaloma S.A. de C.V. (MARCS-CMS 725939, FEI 3002600322) received an FDA Warning Letter dated May 22, 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 June 2, 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
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 Laboratorios Jaloma S.A. de C.V. MARCS-CMS 725939 — May 22, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Electronic Mail - Return Receipt Requested Reference #: 320-26-78 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Jaime Labastida Recipient Title Managing Director Laboratorios Jaloma S.A. de C.V. Calle Emiliano Zapata, No. 422 Oblatos 44380 Guadalajara , Jal. Mexico Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-78 May 22, 2026 Dear Mr. Labastida: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Laboratorios Jaloma S.A. de C.V., FEI 3002600322, located at Calle Aquiles Serdan No. 438, Colonia Oblatos, Guadalajara, Jalisco, from December 15 to 19, 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 January 12, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. During our inspection, our investigators observed specific violations including, but not limited to, the following. 1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)). You failed to accurately document microbiology sampling and testing results for components used in your over-the-counter (OTC) drug products. Your laboratory records did not accurately reflect activities performed. For example, your microbiologist documented the collection of routine (b)(4) samples, but after questioning, your microbiologist admitted that the samples were never actually taken. Furthermore, the microbiologist admitted to routinely performing colony counts after only (b)(4) of incubation, rather than following the required (b)(4) period specified in your procedure. Your firm affirmed this unacceptable practice to our investigators. Your firm’s actions represent a critical breakdown in your laboratory controls and undermine the integrity of your data. In your response, you state that you have updated incubator logbooks to include entry fields for incubation start and end times, provided formal training to personnel, and will perform (b)(4) internal audits to assess effectiveness. Your response is inadequate because it lacks a retrospective assessment to determine the validity of all data generated in your laboratory. Furthermore, your response does not…
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 "critical" severity rating mean for this letter?
- Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
- 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 Laboratorios Jaloma S.A. de C.V. had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Laboratorios Jaloma S.A. de C.V. as of 2026-06-02. 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). Laboratorios Jaloma S.A. de C.V. — FDA Warning Letter, 2026-05-22: CGMP/OTC/Finished Pharmaceuticals/Adulterated. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-laboratorios-jaloma-s-a-de-c-v-2026-05-22-cgmp
"Laboratorios Jaloma S.A. de C.V. — FDA Warning Letter, 2026-05-22: CGMP/OTC/Finished Pharmaceuticals/Adulterated." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-laboratorios-jaloma-s-a-de-c-v-2026-05-22-cgmp.
Argus HQ Research. "Laboratorios Jaloma S.A. de C.V. — FDA Warning Letter, 2026-05-22: CGMP/OTC/Finished Pharmaceuticals/Adulterated." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-laboratorios-jaloma-s-a-de-c-v-2026-05-22-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_laboratorios_jaloma_s_a_de_c_v_2026_05_22_cgmp_2026,
title = {Laboratorios Jaloma S.A. de C.V. — FDA Warning Letter, 2026-05-22: CGMP/OTC/Finished Pharmaceuticals/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-laboratorios-jaloma-s-a-de-c-v-2026-05-22-cgmp},
note = {Accessed: July 13, 2026}
}