https://supplementcheck.org/brand/brainalert-llc/
Is BrainAlert, LLC Safe? FDA Warning Letter Review (2017)
FDA issued a warning letter to BrainAlert, LLC for regulatory violations. Read the full safety review.
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https://supplementcheck.org/brand/itw-dymon/
Is ITW Dymon Safe? FDA Warning Letter Review (2017)
FDA issued a warning letter to ITW Dymon for regulatory violations. Read the full safety review.
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https://www.botable.ai/resources/tools/fda-warning-letters/letters/king-systems-corp-dba-ambu-inc-661617-08162023
King Systems Corp. dba Ambu, Inc.: FDA Warning Letter (Aug 16, 2023) | Botable
FDA warning letter to King Systems Corp. dba Ambu, Inc., issued Aug 16, 2023. Read selected FDA passages, citation references and the original source....
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https://www.fdaweb.com/latest-fda-warning-letter-27/
Latest FDA Warning Letter
Sep 15, 2026 - FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary...
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https://supplementcheck.org/brand/seiki-co-ltd/
Is Seiki Co., Ltd. Safe? FDA Warning Letter Review (2017)
FDA issued a warning letter to Seiki Co., Ltd. for regulatory violations. Read the full safety review.
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https://supplementcheck.org/brand/sunstone-inc/
Is Sunstone, Inc. Safe? FDA Warning Letter Review (2017)
FDA issued a warning letter to Sunstone, Inc. for regulatory violations. Read the full safety review.
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https://www.botable.ai/resources/tools/fda-warning-letters/letters/mjs-medicals-11032025
MJS Medicals: FDA Warning Letter (Nov 3, 2025) | Botable
FDA warning letter to MJS Medicals, issued Nov 3, 2025. Read selected FDA passages, citation references and the original source.
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https://authoritize.ai/atlas/2026-08-fda-nuscience-peptides-llc-kw3zyl/
NuScience Peptides LLC: FDA Warning Letter (2026)
FDA issued a warning letter to NuScience Peptides LLC (Cornelius, NC), operated by Joseph and Ratsamy DeRosa, after a July 2026 website review found the…
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https://www.mintz.com/insights-center/viewpoints/2146/2022-08-22-recent-fda-warning-letter-amazoncom-suggests-agency
Recent FDA Warning Letter to Amazon.com Suggests the Agency Is Getting Tired of the Whack-a-Mole...
Receiving a warning letter from the U.S. Food and Drug Administration (FDA) means that the agency has identified what it calls “violations of regulatory...
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https://supplementcheck.org/brand/miyaquil-sa/
Is MIYAQUIL SA Safe? FDA Warning Letter Review (2017)
FDA issued a warning letter to MIYAQUIL SA for adulteration. Read the full safety review.
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https://argushq.ai/fda/warning-letter/fda-wl-excelvision-fareva-2026-06-25-cgmp
Excelvision - Fareva — FDA Warning Letter, 2026-06-25: CGMP/Finished Pharmaceuticals/Adulterated ·...
The FDA's Center for Drug Evaluation and Research issued a warning letter (320-26-98) to Excelvision - Fareva on June 25, 2026, following an inspection of its A
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https://www.gmp-compliance.org/gmp-news/fda-warning-letter-to-us-manufacturer-highlights-laboratory-deficiencies
FDA Warning Letter to US Manufacturer Highlights Laboratory Deficiencies - ECA Academy
In a recent Warning Letter, the U.S. Food and Drug Administration (FDA) identified significant weaknesses in laboratory controls, missing analytical...
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https://www.weightlossrankings.org/fda-warning-letters/thrivelab-co-dba-thrivelab-728294
Thrivelab FDA Warning Letter #728294 | Weight Loss Rankings
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https://argushq.ai/fda/warning-letter/fda-wl-great-india-overseas-pvt-ltd-dba-silkrute-2026-06-17-unapproved-drug
Unapproved New Drugs: FDA Warning Letter to Great India Overseas Pvt. Ltd. dba Silkrute, 2026-06-17...
FDA's Center for Drug Evaluation and Research (CDER) issued a Warning Letter to Great India Overseas Pvt. Ltd. dba Silkrute on 2026-06-17 regarding Unapproved N
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https://pharmaguidances.com/fda-warning-letter-cgmp-aseptic-processing-violations/
FDA Warning Letter: Major CGMP & Aseptic Processing Violations 483
Oct 6, 2026 - FDA Warning Letter highlights major CGMP, aseptic processing, environmental monitoring, ISO 5 contamination, media fill, smoke study and CAPA deficiencies.
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https://www.botable.ai/resources/tools/fda-warning-letters/letters/virgin-scent-inc-dba-artnaturals-631780-09012022
Virgin Scent Inc. dba Artnaturals: FDA Warning Letter (Sep 1, 2022) | Botable
FDA warning letter to Virgin Scent Inc. dba Artnaturals, issued Sep 1, 2022. Read selected FDA passages, citation references and the original source.
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https://analytical.gmp-compliance.org/news/news-detail/fda-warning-letter-due-to-non-compliance-with-specifications-and-testing.html
FDA warning letter due to non-compliance with specifications and ID testing - Analytical Quality...
Drug manufacturer IDT Australia Ltd. received an FDA warning letter in May 2018. It was criticised during the FDA inspection that OOS results of assay...
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https://argushq.ai/fda/warning-letter/fda-wl-shouly-import-corp-2026-06-26-warning-letter
2026-06-26 FDA Warning Letter: Shouly Import Corp. Cited for Foreign Supplier Verification Program...
The FDA issued a warning letter to Shouly Import Corp. (CMS# 731741) on June 26, 2026, following an April 30, 2026 inspection, citing failure to develop and mai
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https://argushq.ai/fda/warning-letter/fda-wl-nipro-renal-solutions-usa-corporation-2026-07-24-cgmp
CGMP/QSR/Medical Devices/Adulterated: FDA Warning Letter to Nipro Renal Solutions USA, Corporation,...
FDA Center for Devices and Radiological Health issued a warning letter (CMS #732874, July 24, 2026) to Nipro Renal Solutions USA, Corporation, Lewisberry PA, re
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https://pricetrackerglp1.com/safety/warning-letters/maxlife-technologies-inc-dba-maxlife-721453
FDA Warning Letter: MaxLife Technologies Inc. dba (Feb 20, 2026)
FDA's Feb 20, 2026 warning letter to MaxLife Technologies Inc. dba Maxlife naming semaglutide, tirzepatide: the record, its status and FDA's own words.
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https://www.botable.ai/resources/tools/fda-warning-letters/letters/crown-wellness-inc-610844-04292021
Crown Wellness, Inc: FDA Warning Letter (Apr 29, 2021) | Botable
FDA warning letter to Crown Wellness, Inc, issued Apr 29, 2021. Read selected FDA passages, citation references and the original source.
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https://pricetrackerglp1.com/safety/warning-letters/body-good-studio-716460
FDA Warning Letter: Body Good Studio (Sep 9, 2025)
FDA's Sep 9, 2025 warning letter to Body Good Studio naming semaglutide: the record, its status and FDA's own words.
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https://igmpi.ac.in/news/pharma-gmp/otc-drug-production-ceased-after-fda-warning-letter
OTC Drug Production Ceased after FDA Warning Letter
FDA warning halts OTC drug production after citing violations in quality standards and compliance issues.
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https://supplementcheck.org/brand/amaros-co-ltd/
Is Amaros Co., Ltd Safe? FDA Warning Letter Review (2017)
FDA issued a warning letter to Amaros Co., Ltd for cgmp violations. Read the full safety review.
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https://pricetrackerglp1.com/data/telehealth-programs-with-fda-warning-letters
5 of 38 GLP-1 Telehealth Programs Have an FDA Warning Letter (Oct 2026)
5 of the 38 GLP-1 telehealth programs we track received an FDA warning letter; FDA sent 110 telehealth GLP-1 letters to 110 firms. Each letter linked.
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https://pricetrackerglp1.com/safety/warning-letters/ready-med-730317
FDA Warning Letter: Ready Med (Jun 8, 2026)
FDA's Jun 8, 2026 warning letter to Ready Med naming semaglutide, tirzepatide: the record, its status and FDA's own words.
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https://www.food-safety.com/articles/4937-jenie28099s-splendid-ice-cream-responds-to-fda-warning-letter
Jeni’s Splendid Ice Cream Responds to FDA Warning Letter | Food Safety Magazine
Earlier this month, the U.S. Food and Drug Administration (FDA) issued a warning letter to a Jeni’s Splendid Ice Cream manufacturing plant in Columbus, OH...
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https://supplementcheck.org/brand/barnier-production/
Is Barnier Production Safe? FDA Warning Letter Review (2017)
FDA issued a warning letter to Barnier Production for regulatory violations. Read the full safety review.
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https://www.biospace.com/oxygen-therapy-device-for-wound-healing-from-ogenix-corporation-gets-fda-warning-letter
Oxygen Therapy Device for Wound Healing from Ogenix Corporation Gets FDA Warning Letter - BioSpace
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https://supplementcheck.org/brand/old-pueblo-vapor/
Is Old Pueblo Vapor Safe? FDA Warning Letter Review (2017)
FDA issued a warning letter to Old Pueblo Vapor for labeling violations. Read the full safety review.
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https://www.botable.ai/resources/tools/fda-warning-letters/letters/weightless-medical-llc-dba-weightcare-721478-02202026
Weightless Medical LLC dba WeightCare: FDA Warning Letter (Feb 20, 2026) | Botable
FDA warning letter to Weightless Medical LLC dba WeightCare, issued Feb 20, 2026. Read selected FDA passages, citation references and the original source.
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https://www.gmp-compliance.org/gmp-news/fda-warning-letter-visible-particles-and-visual-inspection
FDA Warning Letter: Visible Particles and Visual Inspection - ECA Academy
During an FDA inspection at the Kansas-based company Hospira in mid 2016, the FDA encountered several GMP violations which resulted in a Warning Letter. The...
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https://supplementcheck.org/brand/zara-vape-ltd/
Is Zara Vape Ltd Safe? FDA Warning Letter Review (2017)
FDA issued a warning letter to Zara Vape Ltd for labeling violations. Read the full safety review.
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https://analytical.gmp-compliance.org/news/news-detail/fda-warning-letter-to-chinese-manufacturer-of-otc-products.html
FDA Warning Letter to Chinese Manufacturer of OTC Products - Analytical Quality Control Group
A warning letter to a Chinese manufacturer of OTC drug products continues the series of FDA warning letters on the subject of inadequate testing of starting...
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https://supplementcheck.org/brand/santos-agency-inc/
Is Santos Agency Inc. Safe? FDA Warning Letter Review (2018)
FDA issued a warning letter to Santos Agency Inc. for regulatory violations. Read the full safety review.
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https://argushq.ai/fda/warning-letter/fda-wl-balkanica-llc-2026-06-29-warning-letter
FDA Warning Letter to Balkanica LLC (2026-06-29) — Foreign Supplier Verification Program (FSVP) ·...
The FDA issued a warning letter (CMS# 732478) to Balkanica LLC on June 29, 2026, following an inspection on May 20, 2026, for violations of the Foreign Supplier
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https://www.talkfda.com/program/first-fda-warning-letter-on-ai-1305s
First FDA Warning Letter on AI - 1305S
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https://www.achievexl.com/fda-warningletter-lessons-risk-matrix
Lessons from FDA warning letter - a case study
Failing to update your risk matrix based on information from post-market surveillance can lead to a warning letter from the FDA. In this case study, we discuss...
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https://supplementcheck.org/brand/loreal-usa/
Is Loreal Usa Safe? FDA Warning Letter Review (2017)
FDA issued a warning letter to Loreal Usa for labeling violations. Read the full safety review.
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https://articles.pharmawhiz.com/tag/fda-warning-letter/
FDA warning letter – Pharma Whiz
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https://pharmaguidances.com/fda-warning-letter-cgmp-quality-violations/
FDA Warning Letter: Major CGMP, Quality System & OTC Drug Violations 483
Oct 6, 2026 - FDA warning letter highlights major CGMP violations involving OOS investigations, raw material testing, process validation, cleaning validation, quality...
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https://insider.thefdagroup.com/p/fda-warning-letter-503b-compounding-facility
FDA Warning Letter Breakdown: Inside a 503B Compounder's Quality System Problems
Jul 3, 2025 - A May 5 letter pulls back the curtain on how an outsourcing facility’s quality system unraveled—from unqualified API suppliers to glass in injectable vials.
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https://www.modality-solutions.com/how-to-avoid-an-fda-form-483-or-a-warning-letter-for-your-mab-or-other-biologic/
How to Avoid an FDA Form 483 or a Warning Letter for Your mAb or Other Biologic - Modality Solutions
Sep 15, 2026 - When your mAb or other biologic is moving through the Biologics License Application (BLA) process, a pre-approval inspection (PAI) by the FDA is a critical...
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https://argushq.ai/fda/warning-letter/fda-wl-yangzhou-hongshengding-chemical-co-ltd-2026-06-15-warning-letter
FDA Cites Yangzhou Hongshengding Chemical Co., Ltd. in 2026-06-15 Warning Letter — Refusal to...
On June 15, 2026, FDA's Center for Drug Evaluation and Research issued a warning letter to Yangzhou Hongshengding Chemical Co., Ltd. (FEI 3013166766) for refusi
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