FDA Compliance & Regulatory Insights
FDA Compliance, Quality & Regulatory Intelligence Conversations
Hear candid, high-level conversations with experienced leaders across FDA-regulated industries. These podcasts examine FDA enforcement trends, Form 483 observations, Warning Letters, inspection readiness, quality-system risk, regulatory strategy, manufacturing challenges, and the operational decisions that can determine whether compliance weaknesses are identified early or discovered during an FDA inspection.
Each conversation goes beyond surface-level commentary to explore what Quality, Regulatory, Compliance, Manufacturing, and executive leaders need to understand, what FDA investigators may scrutinize, and how emerging enforcement patterns can translate into practical action.
Mike Kuehne speaks with Paul Arrendel
Overview And details
Exploring AI-driven regulatory signal detection, why experienced organizations miss warning signs, and how asking sharper questions earlier puts leaders ahead.
www.ComplyFDA.Com
Mike Kuehne Speaks With Brett Travaglio
Overview and Details
Mike from ComplyFDA joins Brette Travaglio of Quality Solutions Now to discuss FDA compliance, quality management, regulatory challenges, and risk mitigation across the life sciences industry.
www.ComplyFDA.Com
Mike Kuehne Speaks With Ricki Chase
Overview and Details
Former FDA investigations leader Ricki Chase joins Mike to share firsthand insights on regulatory oversight, inspection readiness, quality systems, and industry compliance.
www.ComplyFDA.Com
FDA WARNING LETTER WATCHRecent publicly posted pharmaceutical, medical device and biologics letters
PharmaceuticalRohto Pharmaceutical Co., Ltd.CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedMedical DeviceOlympus Medical Systems CorporationCGMP/QSR/Medical Devices/AdulteratedBiologicsTides Medical LLCInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA)PharmaceuticalZhejiang Gaorong Cosmetic Co., Ltd.CGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalSignature Formulations LLCCGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalBaxter International Inc.CGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalSnugZ USA, Inc.CGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalLovelace Biomedical Research InstituteGood Laboratory Practice (GLP) for Nonclinical Laboratory StudiesPharmaceuticalEurofins SF Analytical Laboratories, Inc.CGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalSilgan Dispensing SystemsCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugPharmaceuticalHanlim Pharm Co., Ltd.CGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalJiangmen Shuizirun Sanitary Articles Co., Ltd.CGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalSCA Pharmaceuticals, LLCCGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalThe Platinum Healthcare LLCUnapproved New DrugsPharmaceuticalWalmart, Inc.Unapproved New DrugsPharmaceuticalAidance Scientific, Inc.Unapproved New DrugsPharmaceuticalGraceful Touch, LLCUnapproved New DrugsPharmaceuticalAmazon.com, Inc.Unapproved New DrugsPharmaceuticalOrganiCare, LLC / OrganiCare Nature’s Science, LLCUnapproved New DrugsPharmaceuticalTerramedUnapproved New DrugsPharmaceuticalBioactive Services USA, LLC / Herstat Inc.Unapproved New DrugsPharmaceuticalDesBio/Deseret Biologicals, Inc.Unapproved New DrugsPharmaceuticalRoyceDerm LLCUnapproved New DrugsPharmaceuticalCheap Medicine Shop/www.cheapmedicineshop.comUnapproved New Drugs/Misbranded (Internet Pharmacy)PharmaceuticalOnline Generic Medicine/www.onlinegenericmedicine.comUnapproved New Drug/Misbranded (Internet Pharmacy)Medical DeviceUnilam Co., LTDCGMP/QSR/Medical Devices/AdulteratedPharmaceuticalTCI Co., Ltd BioCosme PABP BRANCHCGMP/Finished Pharmaceuticals/AdulteratedMedical DeviceO.N. Diagnostics, LLCMedical Device Reporting/MisbrandedPharmaceuticalPine Pharmaceuticals, LLCCompounding Pharmacy/Adulterated Drug ProductsPharmaceuticalFresenius Kabi USA LLCCGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalBabikian Healthcare Products CJSCCGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalCuria New York, Inc.CGMP/Active Pharmaceutical Ingredient (API)/AdulteratedPharmaceuticalBentley Laboratories LLCCGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedPharmaceuticalCelmadeReview of Website/Unapproved New Drug/MisbrandedPharmaceuticalVeganicSKN LimitedCGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalStream2Sea, LLCCGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalKellin Chemicals Co., Ltd. - ZhangjiagangCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedPharmaceuticalEmpower Clinic Services, LLC dba Empower PharmacyCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugBiologicsNexCell Scientific IncUnapproved New Drugs/Unlicensed Biological Product ViolationsPharmaceuticalkdc/one Chatsworth, Inc.CGMP/Finished Pharmaceuticals/AdulteratedMedical DeviceAdvance-Esthetic LLCInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated DeviceMedical DeviceLion Street Medical, d/b/a Pensar Medical LLCMedical Device Reporting/MisbrandedMedical DeviceSpecialty Health Products CO, LLCCGMP/QSR/Medical Devices/AdulteratedPharmaceuticalBausch & Lomb Inc.CGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalHappy Farm Botanicals, Inc.CGMP/Finished Pharmaceuticals/AdulteratedBiologicsStephen J. Fallon, Ph.D.Bioresearch Monitoring Program/Institutional Review Board (IRB)PharmaceuticalJabil Inc.CGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalFresenius Medical Care AG & Co. KGaACGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalPeak Performance PeptidesUnapproved New Drugs/MisbrandedPharmaceuticalRoyal Peptides LLCUnapproved New Drugs/MisbrandedPharmaceuticalNuScience Peptides LLCUnapproved New Drugs/MisbrandedPharmaceuticalPeptide Partners LLCUnapproved New Drugs/MisbrandedPharmaceuticalTXP Innovations LLC dba Tex PeptidesUnapproved New Drugs/MisbrandedPharmaceuticalReliance Life Sciences Private LimitedCGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalShoolin Pharma Chem LLPCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedPharmaceuticalPReye, LLCCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugBiologicsR3 Medical CompaniesUnapproved New Drugs/Unlicensed Biological Product ViolationsPharmaceuticalSuretec Innovations, LLCCGMP/Finished Pharmaceuticals/Adulterated and MisbrandedPharmaceuticalEugia Pharma Specialities LimitedCGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalK.C. Pharmaceuticals, Inc.CGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalAuriga Research Pvt. Ltd.CGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalSafrel Pharmaceuticals LLCCGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalTianjin Kilo Pharmaceutical Sci-tech Co., Ltd.CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/MisbrandedMedical DeviceNipro Renal Solutions USA, CorporationCGMP/QSR/Medical Devices/AdulteratedPharmaceuticalFairyGene, Inc.CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedPharmaceuticalLico Industries, LLC., d.b.a. American Towelette CompanyCGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalWoodbine Products Company Inc.CGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalMaria E. De La Torre Silva, M.D.Clinical InvestigatorPharmaceuticalThomas Brunner Hygiene GmbHCGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedPharmaceuticalDabur India LimitedCGMP/Finished Pharmaceuticals/AdulteratedMedical DeviceKoven Technologies, Inc.CGMP/QSR/Medical Devices/AdulteratedMedical DeviceLinemaster Switch CorporationCGMP/QSR/Drug/Medical Devices/AdulteratedPharmaceuticalIsland Kinetics, Inc. d.b.a. CoValence LaboratoriesCGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedPharmaceuticalAlmon Healthcare Private LimitedCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedPharmaceuticalBioMylz Pvt. Ltd.CGMP/Finished Pharmaceuticals/Adulterated/MisbrandedPharmaceuticalShimoga ChemicalsCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedPharmaceuticalPratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.In Vivo Bioavailability-Bioequivalence Studies – ClinicalPharmaceuticalSpa De Soleil, Inc.CGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalInternational Medication Systems LimitedCGMP/Finished Pharmaceuticals/AdulteratedMedical DeviceNihon Kohden Digital Health Solutions, LLCMedical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)Medical DeviceZIIP, Inc.CGMP/QSR/Medical Devices/AdulteratedPharmaceuticalKetacyn Pharmaceuticals / www.ketacynpharma.comUnapproved New Drugs/MisbrandedPharmaceuticalExtra Medication / www.extramedication.comUnapproved New Drugs/MisbrandedPharmaceuticalPure Arylcyclohexylamine Store / www.arylcyclohexylamine.comUnapproved New Drugs/MisbrandedPharmaceuticalAll Ketamine HCL / www.allketaminehcl.comUnapproved New Drugs/MisbrandedPharmaceuticalKetamine Troche Store / www.ketaminetrochestore.comUnapproved New Drugs/MisbrandedPharmaceuticalBuy Keta Online / www.buyketaonline.comUnapproved New Drugs/MisbrandedPharmaceuticalKetamine Store / www.ketaminestore.orgUnapproved New Drugs/MisbrandedPharmaceuticalLegit Ketamine Suppliers / www.legitketaminesuppliers.comUnapproved New Drugs/MisbrandedPharmaceuticalKetdaxandrugs / www.ketdaxandrugs.orgUnapproved New Drugs/MisbrandedPharmaceuticalketaminetroches.comUnapproved New Drugs/MisbrandedPharmaceuticalMed Shop Inc / www.medshopinc.comUnapproved New Drugs/MisbrandedPharmaceuticalLyfeUnit / www.lyfeunit.comUnapproved New Drugs/MisbrandedPharmaceuticalKeta Med Lab / www.ketamedlab.comUnapproved New Drugs/MisbrandedPharmaceuticalKet Plug / ketaminelab.org and buyketaminepowderonline.comUnapproved New Drugs/MisbrandedMedical DeviceBlephEx, LLCMedical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)Medical DeviceSkytron, LLCMedical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)PharmaceuticalExcelvision - FarevaCGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalWizcure Pharmaa Private LimitedCGMP/Finished Pharmaceuticals/AdulteratedBiologicsGenzyme Ireland LimitedCGMP/Deviations/Biologics License Application (BLA)PharmaceuticalYangzhou Hongshengding Chemical Co., Ltd.Refusal to Provide Access to and Copying of RecordsMedical DeviceAseptiKits, LLCInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated DeviceMedical Device3B Medical, Inc. dba Reach Health, Inc.CGMP/QSR/Medical Devices/AdulteratedMedical DeviceBMC Medical Co., Ltd.CGMP/QSR/Medical Devices/PMA/Adulterated/MisbrandedPharmaceuticalAmazon.com, Inc.Unapproved New Drugs/MisbrandedPharmaceuticalGreat India Overseas Pvt. Ltd. dba SilkruteUnapproved New DrugsPharmaceuticalLeading Edge Health Inc.Unapproved New Drugs/MisbrandedPharmaceuticalIndiangoods.shopUnapproved New Drugs/MisbrandedPharmaceuticalWild Arabic HerbsUnapproved New Drugs/MisbrandedPharmaceuticalHerbal Dermals LLC FZ dba GotucreamUnapproved New Drugs/MisbrandedPharmaceuticalHadassah Healing Oils LtdUnapproved New DrugsPharmaceuticalJJLBROUnapproved New Drugs/MisbrandedPharmaceuticalTelos Trading Limited dba AlwinshopUnapproved New Drugs/MisbrandedPharmaceuticalMantroForceUnapproved New Drugs/MisbrandedPharmaceuticalWholesale PeptideUnapproved New Drugs/MisbrandedPharmaceuticalTexinkart Inc.Unapproved New Drugs/MisbrandedPharmaceuticalHuons Co., Ltd.CGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalJubilant HollisterStier General PartnershipCGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalNativeMed LLC dba NativeMedFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalHydraMed IV LLC dba HydraMedFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalNexus Health Solutions LLC dba Harper MedsFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalFitRX, LLC dba AM RXFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalAltru Telehealth, LLC dba Altru TelehealthFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalEden Health International Inc. dba EdenFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalTrinity HealthCare Supply, LLC dba altRxFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalAmie Health, Inc. dba AmieFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalThrivelab Co. dba ThrivelabFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalVivioMD Group LLC dba VivioMDFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalGlow Medispa, LLC dba Mint MedFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalNexlife Inc. dba NexlifeFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalPublic Health Solution LLC dba DrMedHealthFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalD&H Medical ServicesFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalMomentum Health 360 dba Momentum HealthFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalMedica Weight LossFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalEzra Holdco LLC dba EzraFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalReady MedFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalFITISHFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalOrderlyMeds LLC dba OrderlyMedsFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalRoen Health, Inc. dba RoenRxFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalJoi and Blokes dba Joi + BlokesFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalNova Vascular LLC dba NOVARXFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalClover Meds LLC dba Clover MedsFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalMaximus Health, Inc. dba MaximusFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalSante Manufacturing Inc.CGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalInvaDerm, Inc.Electronic Drug Registration and Listing System (eDRLS)/ViolationsPharmaceuticalPharmathen International S.A.CGMP/Active Pharmaceutical Ingredient (API)/AdulteratedMedical DeviceZOLL Medical CorporationCGMP/QSR/Medical Devices/AdulteratedMedical DeviceHappiest Baby, Inc.Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated DevicePharmaceuticalHubei Gedian Humanwell Pharmaceutical Co., Ltd.CGMP/Active Pharmaceutical Ingredient (API)/AdulteratedPharmaceuticalGopaldas Visram & Co., Ltd.CGMP/OTC Finished Pharmaceuticals/AdulteratedPharmaceuticalLaboratorios Dr. Collado S.A.CGMP/OTC Finished Pharmaceuticals/AdulteratedPharmaceuticalRevlon Group Holdings, LLCCGMP/OTC Finished Pharmaceuticals/AdulteratedPharmaceuticalUmendra Life Sciences Private LimitedCGMP/OTC Finished Pharmaceuticals/AdulteratedPharmaceuticalErkul Kozmetik Sanayi ve Ticaret A.S.CGMP/OTC Finished Pharmaceuticals/AdulteratedPharmaceuticalPLZ CorpCGMP/OTC Finished Pharmaceuticals/AdulteratedPharmaceuticalAsanuma Corporation - Sagamihara FactoryCGMP/OTC Finished Pharmaceuticals/AdulteratedPharmaceuticalShantou Qiwei Industry Co., LTDCGMP/OTC Finished Pharmaceuticals/AdulteratedPharmaceuticalZydus Lifesciences LimitedRequest for Records/CGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalMacau-Union Pharmaceutical LimitedNonprescription/OTCPharmaceuticalJose M. Carpio, M.D.Clinical InvestigatorPharmaceuticalFagron BVCompounding Pharmacy/Adulterated Drug ProductsPharmaceuticalMedline IncCGMP/Finished Pharmaceuticals/AdulteratedBiologicsBlue Horizon International, LLCUnapproved New Drugs/Unlicensed Biological Product ViolationsPharmaceuticalLaboratorios Jaloma S.A. de C.V.CGMP/OTC/Finished Pharmaceuticals/AdulteratedPharmaceuticalAeroflex Industria de Aerosol Ltda.Refusal to Provide Access to and Copying of RecordsPharmaceuticalHealthPartners Neuroscience Center Research and InnovationGood Laboratory Practice (GLP) for Nonclinical Laboratory StudiesPharmaceuticalAlchymars ICM SM Private LimitedCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedPharmaceuticalSato Pharmaceutical Co., Ltd.CGMP/Drugs/Adulterated/OTCPharmaceuticalGSC Products, LLCNonprescription/OTCPharmaceuticalAja Health and Wellness Inc.Nonprescription/OTCPharmaceuticalGC America, Inc.CGMP/Finished Pharmaceuticals/AdulteratedBiologicsAdnan Dahdul, MDClinical Investigator/BIMOPharmaceuticalLus Essentials LLCUnapproved New Drugs/MisbrandedPharmaceuticalLa Crema De RebecaUnapproved New Drugs/MisbrandedPharmaceuticalPolleyMed, LLCNonprescription/OTCPharmaceuticalNaseem A. Jaffrani, M.D.Clinical InvestigatorPharmaceuticalHarbin Jixianglong Biotech Co., Ltd.CGMP/API/Adulterated and Misbranded DrugsPharmaceuticalSourav K. Mishra, M.D. / All India Institute of Medical SciencesIn Vivo Bioavailability-Bioequivalence Studies – ClinicalPharmaceuticalHangzhou Yiqi Biotechnology Co., LtdCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedPharmaceuticalJW Nutritional LLCCGMP/OTC Finished Pharmaceuticals/AdulteratedPharmaceuticalIDO Pharm Co., Ltd.CGMP/OTC Finished Pharmaceuticals/AdulteratedPharmaceuticalNaveh Pharma LTD/Bigdam Inc.CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugPharmaceuticalMukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research CentreIn Vivo Bioavailability-Bioequivalence Studies – ClinicalBiologicsEstar Technologies LtdInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated DevicePharmaceuticalProRx LLCCompounding Pharmacy/Adulterated Drug ProductsPharmaceuticalCareFusion 213, LLCCGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalRay’s VitaminsUnapproved New Drug/MisbrandedPharmaceuticalibeautistore.comUnapproved New Drug/MisbrandedPharmaceuticalActive Cosmetics Manufacturing Inc.CGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalRespilon Production S.R.O.CGMP/OTC/Finished Pharmaceuticals/AdulteratedMedical DeviceUnetixs Vascular, Inc.Premarket Approval/AdulteratedPharmaceuticalAva Inc.CGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalFoshan Miwei Cosmetics Co., Ltd.Nonprescription/OTCPharmaceuticalLexia LLCCGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalIntas Pharmaceuticals LimitedCGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalSaNOtizeUnapproved New DrugsPharmaceuticalPar Health USA, LLC & Endo USA, Inc.CGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalNew Life Pharma LLCCGMP/Adulterated and Unapproved New Drug/MisbrandedPharmaceuticalPro Numb Tattoo Numbing Spray, LLCNonprescription/OTCPharmaceuticalUCSF Radiopharmaceutical FacilityCGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalXiamen Kang Zhongyuan Biotechnology Co., Ltd.CGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalRC Outsourcing, LLCCompounding Pharmacy/Adulterated Drug ProductsPharmaceuticalThrive Health and Wellness, LLC dba Thrive Health SolutionsCompounding Pharmacy/Adulterated Drug ProductsPharmaceuticalApollo Care, LLCCompounding Pharmacy/Adulterated Drug ProductsPharmaceuticalMedical Products Laboratories, Inc.CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugPharmaceuticalChemco CorporationNonprescription/OTCPharmaceuticalPurolea Cosmetics LabCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugPharmaceuticalBeauty of Aztlan LLCNotice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the InternetPharmaceuticalDry Springs PharmacyNotice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the InternetPharmaceuticalOnline Rx MedzNotice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the InternetPharmaceuticalRxgoodusaNotice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the InternetPharmaceuticalPure Indulgence AestheticsDrug Supply Chain Security Act (DSCSA) ViolationsPharmaceuticalLovega LLC dba Pink Pony PeptidesUnapproved New Drugs Sold Over the InternetPharmaceuticalGuangzhou Huli Technology Co., Ltd. dba Fantasy FaceUnapproved New Drugs Sold Over the InternetPharmaceuticalGram PeptidesUnapproved New Drugs Sold Over the InternetPharmaceuticalPrime SciencesUnapproved New Drugs Sold Over the InternetPharmaceuticalFormPourUnapproved New Drugs Sold Over the InternetPharmaceuticalMile High Compounds LLCUnapproved New Drugs Sold Over the InternetPharmaceuticalPekCura LabsUnapproved New Drugs Sold Over the InternetPharmaceuticalEhsan Sadri, M.D.Clinical InvestigatorMedical DeviceMedline Industries, LPCGMP/QSR/Medical Devices/AdulteratedPharmaceuticalMicrobiological Testing & Consulting, LLCCGMP/Finished Pharmaceuticals/AdulteratedMedical DevicePhysitemp Instruments, LLCCGMP/QSR/Medical Devices/AdulteratedPharmaceuticalYangzhou H&R Plastic Daily Chemical Co., Ltd.CGMP/Finished Pharmaceuticals/AdulteratedBiologics4U HealthPremarket Approval/AdulteratedMedical DeviceLonghorn Vaccines and Diagnostics LLCCGMP/QSR/Medical Devices/AdulteratedMedical DeviceIsoTis OrthoBiologics, Inc.CGMP/QSR/Medical Devices/AdulteratedPharmaceuticalPatcos Cosmetics Pvt. Ltd.Finished Drug Products/AdulteratedPharmaceuticalOraLabs, Inc.CGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalFlowchem Pharma Private LimitedCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedPharmaceuticalVedic Lifesciences Pvt. Ltd.Good Laboratory Practice (GLP) for Nonclinical Laboratory StudiesPharmaceuticalCitra100mgUnapproved New Drugs/MisbrandedPharmaceuticalApothecary Pharma, LLCCompounding Pharmacy/Adulterated Drug ProductsMedical DeviceAvertix Medical, Inc.CGMP/QSR/Medical Devices/AdulteratedPharmaceuticalNovo Nordisk Inc.Postmarketing Adverse Drug Experience Reporting RequirementsPharmaceuticalSimtra BioPharma SolutionsCGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalTentamus India Private LimitedCGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalFareva Morton GroveCGMP/Finished Pharmaceuticals/AdulteratedPharmaceuticalNSE Products, Inc. DBA Nu Skin Enterprises, Inc.Electronic Drug Registration and Listing System (eDRLS)/ViolationsMedical DeviceExactech, Inc. dba Advita OrthoCGMP/QSR/Medical Devices/AdulteratedPharmaceuticalPremium Health Management Inc. dba Premium HealthFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalZeuss LLC dba ZeussFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalLean Rx, Inc. dba SkinnyRxFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalKare Solutions, LLC dba ZappyFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalStrut Health, LLC dba StrutFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalRefills Health, LLC dba Refills HealthFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalWeightless Medical LLC dba WeightCareFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalViv Health, Inc. dba VIV RXFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalPeaks Curative, LLC dba PeaksFalse & Misleading Claims/Misbranded (Telehealth)PharmaceuticalPharmaZeeFalse & Misleading Claims/Misbranded (Telehealth)
Source: FDA Warning Letters spreadsheet • Latest included posting: 10/20/2026 • Static snapshot, not a live FDA feed. FDA Warning Letters
Stay Ahead of FDA Enforcement Trends
FDA expectations, inspection priorities, and enforcement patterns continue to evolve. Stay connected to conversations that help Quality, Regulatory, Compliance, Manufacturing, and executive leaders recognize emerging risks before they become Form 483 observations, Warning Letters, costly remediation, or operational disruption.
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