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FDA Warning Letters, 483s and Recalls: November 2023

FDA enforcement records dated November 2023: 40 warning letters outside tobacco (plus 31 tobacco letters), 49 OAI inspections and 253 Class I recalls. FDA publishes some records weeks after their date, so recent months can still grow.

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Warning letters

A warning letter is FDA's formal notice that a firm has significant violations. Company names link to the letter on fda.gov. Tobacco retailer letters are counted above but not listed.

DateCompanyIssuing officeSubject
Nov 30, 2023American Aquarium ProductsCenter for Veterinary MedicineUnapproved Medically Important Antimicrobials Marketed for Use in Non-food Minor Species
Nov 30, 2023Aquanest BioticCenter for Veterinary MedicineUnapproved Medically Important Antimicrobials Marketed for Use in Non-food Minor Species
Nov 30, 2023Aquarium Pharmacy LLCCenter for Veterinary MedicineUnapproved Medically Important Antimicrobials Marketed for Use in Non-food Minor Species
Nov 30, 2023California Veterinary SupplyCenter for Veterinary MedicineUnapproved Medically Important Antimicrobials Marketed for Use in Non-food Minor Species
Nov 30, 2023Chewy, Inc.Center for Veterinary MedicineUnapproved Medically Important Antimicrobials Marketed for Use in Non-food Minor Species
Nov 30, 2023Distribuidora Jocorena Inc.Division of Northeast ImportsForeign Supplier Verification Program (FSVP)
Nov 30, 2023Kraft DrugCenter for Veterinary MedicineUnapproved Medically Important Antimicrobials Marketed for Use in Non-food Minor Species
Nov 30, 2023Midland Vet ServicesCenter for Veterinary MedicineUnapproved Medically Important Antimicrobials Marketed for Use in Non-food Minor Species
Nov 30, 2023Silver Lease, LLCCenter for Veterinary MedicineUnapproved Medically Important Antimicrobials Marketed for Use in Non-food Minor Species
Nov 30, 2023Valley Vet SupplyCenter for Veterinary MedicineUnapproved Medically Important Antimicrobials Marketed for Use in Non-food Minor Species
Nov 29, 2023Litehouse, Inc.Office of Human and Animal Food Operations Division East 6CGMP Food Labeling/Allergen/Misbranded
Nov 29, 2023Regal Health Food International, Inc.Division of Human and Animal Food Operations East VIFood Labeling/Misbranded
Nov 28, 2023Marion Mullet FarmDivision of Human and Animal Food Operations East VINew Animal Drug/Adulterated
Nov 24, 2023Cooperstown Cheese Company, LLCDivision of Human and Animal Food Operations East ICGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
Nov 22, 2023Dr. Berne’S Whole Health ProductsCenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Nov 22, 2023Euro USA IncDivision of Human and Animal Food Operations East VSeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Nov 21, 2023Intas Pharmaceuticals LimitedCenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Nov 17, 2023AmLion Toothpaste Mfg. Sdn. Bhd.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Nov 17, 2023Cipla LimitedCenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Nov 17, 2023Nantong Furuida Packaging Products Co., Ltd.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Nov 16, 2023Cerci Kozmetik Ve Otel Ekipmanlari Pazarlama Ic Ve Dis Ticaret Limited SirketiCenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Nov 16, 2023Discover Health, LLC D/B/A Discover CBD And Strain SnobsCenter for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drugs/Animal Drugs/Human Foods/Animal Foods/Adulterated/Misbranded
Nov 15, 2023Xiamen Wally Bath Manufacture Co., Ltd.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Nov 14, 2023Martin Farm, Konrad MartinDivision of Human and Animal Food Operations East VINew Animal Drug/Adulterated
Nov 13, 2023Amazon.Com, Inc.Center for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded
Nov 13, 2023Sudesan Temizlik Urunleri Ve Ambalaj Sanaryi Ticaret Anomin SirketiCenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Nov 9, 2023Wan-Gee Foods, Inc.Division of Human and Animal Food Operations West IICGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
Nov 8, 2023Cavevi Naturals LLCDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Nov 8, 2023Melanie M. Hoppers, M.D./Physicians Quality CareCenter for Drug Evaluation and Research | CDERClinical Investigator
Nov 8, 2023National Chemical LaboratoriesOffice of Pharmaceutical Quality OperationsCGMP/Finished Pharmaceuticals/Adulterated
Nov 8, 2023Wello Inc.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Misbranded
Nov 8, 2023Www.Directpharmashop.NetCenter for Drug Evaluation and Research | CDERUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
Nov 7, 2023Deymed Diagnostic S.R.O."OHT5: Office of Neurological and Physical Medicine Devices, Office of Product Evaluation and Quality"CGMP/QSR/Medical Devices/Adulterated
Nov 6, 2023Lone Star Botanicals Inc.Division of Human and Animal Food Operations East IIICGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Nov 6, 2023Saruhan Kimya Ve Temizlik Urunleri Sanayi Ticaret Anonim Sirketi Corlu SubesiCenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Nov 3, 2023Independent Seafoods Panama, S.A. Dba Panama Artisanal Seafoods FQCenter for Food Safety and Applied NutritionSeafood HACCP/CGMP for Foods/Adulterated
Nov 3, 2023PESCAMOZ LDACenter for Food Safety and Applied NutritionSeafood HACCP/CGMP for Foods/Adulterated
Nov 3, 2023Trang Thuy Seafood Co., LTDCenter for Food Safety and Applied Nutrition (CFSAN)Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Nov 1, 2023Appleton City Feed Service LLCDivision of Human and Animal Food Operations West IICGMP/Medicated Feeds/Adulterated
Nov 1, 2023Terragene S.A.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated

OAI inspections

OAI (Official Action Indicated) means FDA recommends regulatory and/or administrative action after the inspection. Facility names link to the facility's FDA record.

DateFacilityProduct typeCountry
Nov 30, 2023ALWAYS FRESCO LLCFood/CosmeticsUnited States
Nov 30, 2023Eurolatex Sdn.Bhd.DevicesMalaysia
Nov 30, 2023Health SpecialtyDrugsUnited States
Nov 28, 2023California Bread Co.Food/CosmeticsUnited States
Nov 28, 2023LA Royal Inc.TobaccoUnited States
Nov 23, 2023TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC.DevicesTaiwan
Nov 22, 2023Grupo Quimico SRLDrugsUruguay
Nov 22, 2023Signature Formulations, LLCDrugsUnited States
Nov 20, 2023Mena Food Group, LLC.Food/CosmeticsUnited States
Nov 20, 2023STPCA Inc.Food/CosmeticsUnited States
Nov 20, 2023Vintage Chemical, Inc.DrugsUnited States
Nov 20, 2023Westwood Laboratories, LLC.DrugsUnited States
Nov 17, 2023Antaria Pty. Ltd.DrugsAustralia
Nov 17, 2023GLOBAL WIDGET LLCDrugsUnited States
Nov 17, 2023Ken Prima Cosmeceuticals, Sdn. Bhd.DrugsMalaysia
Nov 17, 2023Lin Shen, M.D.DrugsChina
Nov 17, 2023Universal Packaging Systems, Inc.DrugsUnited States
Nov 16, 2023Abbott VascularDevicesIreland
Nov 16, 2023Aruba Aloe Balm N.V.DrugsAruba
Nov 16, 2023Cooper Institute For Advanced Reproductive MedicineBiologicsUnited States
Nov 15, 2023Meditco, Inc. D.B.A. Phoenicia Specialty FoodsFood/CosmeticsUnited States
Nov 15, 2023Q-Pharm Inc.VeterinaryCanada
Nov 15, 2023Tongliao Meihua Biological Sci-Tech Co., Ltd.Food/CosmeticsChina
Nov 14, 2023Ajinomoto Health & Nutrition North America IncDrugsUnited States
Nov 14, 2023American Cruise Lines IncFood/CosmeticsUnited States
Nov 14, 2023Txsyn Int. LLCFood/CosmeticsUnited States
Nov 13, 2023Deerview Dairy LPVeterinaryUnited States
Nov 13, 2023Massos Food Industries Sdn BhdFood/CosmeticsMalaysia
Nov 13, 2023Michael Chung, M.D.DrugsUnited States
Nov 10, 2023Betone, S.A. De C.V.DrugsMexico
Nov 10, 2023C&T Dream Co., Ltd.DrugsKorea (the Republic of)
Nov 10, 2023Homart Pharmaceuticals Pty. Ltd.Food/CosmeticsAustralia
Nov 10, 2023Laboratorio Magnachem International, S.A.DrugsDominican Republic (the)
Nov 10, 2023RONGCHENG JIAYUAN FOODS (3Rd Workshop) CO., LTDFood/CosmeticsChina
Nov 10, 2023Vega Technologies Inc.DevicesChina
Nov 9, 2023AVASOL LLCDrugsUnited States
Nov 9, 2023BIOPTIMAL INTERNATIONAL PTE. LTD.DevicesSingapore
Nov 9, 2023CARGILL INCORPORATEDVeterinaryUnited States
Nov 9, 2023Formulation Technology LLCFood/CosmeticsUnited States
Nov 9, 2023HIDREX GmbHDevicesGermany
Nov 9, 2023Hybrid Pharma LLCDrugsUnited States
Nov 8, 2023ACMH Hospital IRBDrugsUnited States
Nov 7, 2023AnuMed International LLCDrugsUnited States
Nov 6, 2023DP INTERNATIONAL TRADING LLCFood/CosmeticsUnited States
Nov 6, 2023SUNFLOWER TRADING LLCFood/CosmeticsUnited States
Nov 3, 2023CUE HEALTH INCDevicesUnited States
Nov 3, 2023Pinnacle Labs Of Tennessee, LLCDevicesUnited States
Nov 3, 2023Sani-Care Salon Products, IncDrugsUnited States
Nov 1, 2023Marudhar ImpexFood/CosmeticsIndia

Most-cited Form 483 sections

The CFR sections FDA investigators cited most often in inspections that ended this month.

CFR sectionObservationCitations
21 CFR 1.502(a)Develop FSVP35
21 CFR 117.130(a)(1)Hazard analysis - Identification of hazard19
21 CFR 820.100(a)Lack of or inadequate procedures18
21 CFR 820.198(a)Lack of or inadequate complaint procedures17
21 CFR 111.70(e)Specifications - identity, purity, strength, composition16
21 CFR 211.160(b)Scientifically sound laboratory controls15
21 CFR 211.192Written record of investigation incomplete15
21 CFR 117.35(a)Sanitary operations - Plant sanitation14
21 CFR 1.505(a)(2)Evaluation - performance, risk14
21 CFR 211.22(d)Procedures not in writing, fully followed14

Class I recalls

Class I is FDA's most serious recall class: a reasonable chance the product causes serious health problems or death.

DateFirmProduct typeReason
Nov 30, 2023Busse Hospital Disposables, Inc.DevicesFirm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in…
Nov 30, 2023Busse Hospital Disposables, Inc.DevicesFirm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in…
Nov 30, 2023Busse Hospital Disposables, Inc.DevicesFirm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in…
Nov 30, 2023Insulet CorporationDevicesThe bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an…
Nov 30, 2023Lara's Bakery 3 LLCFoodUndeclared allergens - sesame seed, coconut, soy, milk. Potential for unintended allergen presence (Sesame, Coconut, Soy, Wheat, Milk and…
Nov 30, 2023Lara's Bakery 3 LLCFoodUndeclared allergens - sesame. Potential for unintended allergen presence (Sesame, Coconut, Soy, Wheat, Milk and Eggs).
Nov 29, 2023Fresenius Kabi USA, LLCDevicesThe device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to…
Nov 29, 2023Meta HerbalDrugsMarketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.
Nov 29, 2023TGD Cuts, LLCFoodPotential Salmonella Contamination
Nov 29, 2023TGD Cuts, LLCFoodPotential Salmonella Contamination
Nov 29, 2023TGD Cuts, LLCFoodPotential Salmonella Contamination
Nov 29, 2023TGD Cuts, LLCFoodPotential Salmonella Contamination
Nov 29, 2023TGD Cuts, LLCFoodPotential Salmonella Contamination
Nov 29, 2023TGD Cuts, LLCFoodPotential Salmonella Contamination
Nov 29, 2023TGD Cuts, LLCFoodPotential Salmonella Contamination
Nov 29, 2023TGD Cuts, LLCFoodPotential Salmonella Contamination
Nov 29, 2023TGD Cuts, LLCFoodPotential Salmonella Contamination
Nov 29, 2023TGD Cuts, LLCFoodPotential Salmonella Contamination
Nov 29, 2023TGD Cuts, LLCFoodPotential Salmonella Contamination
Nov 29, 2023TGD Cuts, LLCFoodPotential Salmonella Contamination
Nov 29, 2023TGD Cuts, LLCFoodPotential Salmonella Contamination
Nov 29, 2023TGD Cuts, LLCFoodPotential Salmonella Contamination
Nov 29, 2023TGD Cuts, LLCFoodPotential Salmonella Contamination
Nov 27, 2023Kwik Trip, Inc.FoodPotential Salmonella Contamination.
Nov 27, 2023Kwik Trip, Inc.FoodPotential Salmonella Contamination.
Nov 27, 2023Kwik Trip, Inc.FoodPotential Salmonella Contamination.
Nov 24, 2023Cut Fruit Express, Inc.FoodCantaloupe containing products may be contaminated with Salmonella.
Nov 24, 2023Cut Fruit Express, Inc.FoodCantaloupe containing products may be contaminated with Salmonella.
Nov 24, 2023Cut Fruit Express, Inc.FoodCantaloupe containing products may be contaminated with Salmonella.
Nov 24, 2023Cut Fruit Express, Inc.FoodCantaloupe containing products may be contaminated with Salmonella.
Nov 24, 2023Cut Fruit Express, Inc.FoodCantaloupe containing products may be contaminated with Salmonella.
Nov 24, 2023Cut Fruit Express, Inc.FoodCantaloupe containing products may be contaminated with Salmonella.
Nov 24, 2023Cut Fruit Express, Inc.FoodCantaloupe containing products may be contaminated with Salmonella.
Nov 24, 2023Houdini Inc.FoodUndeclared allergens; tree nuts
Nov 24, 2023Houdini Inc.FoodUndeclared allergens; tree nuts
Nov 24, 2023Houdini Inc.FoodUndeclared allergens; tree nuts
Nov 24, 2023Houdini Inc.FoodUndeclared allergens; tree nuts
Nov 24, 2023Houdini Inc.FoodUndeclared allergens; tree nuts
Nov 24, 2023Houdini Inc.FoodUndeclared allergens; tree nuts
Nov 24, 2023Houdini Inc.FoodUndeclared allergens; tree nuts
Nov 24, 2023Houdini Inc.FoodUndeclared allergens; tree nuts
Nov 24, 2023Houdini Inc.FoodUndeclared allergens; tree nuts
Nov 24, 2023PACIFIC TRELLIS FRUIT, LLCFoodSalmonella
Nov 24, 2023Renaissance Food GroupFoodSalmonella
Nov 24, 2023Renaissance Food GroupFoodSalmonella
Nov 24, 2023Renaissance Food GroupFoodSalmonella
Nov 24, 2023Renaissance Food GroupFoodSalmonella
Nov 24, 2023Renaissance Food GroupFoodSalmonella
Nov 24, 2023Renaissance Food GroupFoodSalmonella
Nov 24, 2023Renaissance Food GroupFoodSalmonella
Nov 24, 2023Renaissance Food GroupFoodSalmonella
Nov 24, 2023Renaissance Food GroupFoodSalmonella
Nov 24, 2023Renaissance Food GroupFoodSalmonella
Nov 24, 2023Renaissance Food GroupFoodSalmonella
Nov 24, 2023Renaissance Food GroupFoodSalmonella
Nov 24, 2023Renaissance Food GroupFoodSalmonella
Nov 24, 2023Renaissance Food GroupFoodSalmonella
Nov 24, 2023Renaissance Food GroupFoodSalmonella
Nov 24, 2023Renaissance Food GroupFoodSalmonella
Nov 22, 2023Crown Jewels Produce Company, LLCFoodSalmonella contamination
Nov 22, 2023Insight Pharmaceuticals CorporationDrugsChemical Contamination; presence of benzene.
Nov 22, 2023Novartis Pharmaceuticals CorporationDrugsCrystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Nov 20, 2023CF Dallas LLCFoodThe select fresh-cut products were made from whole cantaloupe subject to a previously announced voluntary recall initiated by Sofia…
Nov 20, 2023Hilltop Meadow FarmFoodPotential contamination with Listeria monocytogenes
Nov 20, 2023ResMed Ltd.DevicesMasks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical…
Nov 20, 2023ResMed Ltd.DevicesMasks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical…
Nov 20, 2023ResMed Ltd.DevicesMasks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical…
Nov 20, 2023ResMed Ltd.DevicesMasks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical…
Nov 20, 2023ResMed Ltd.DevicesMasks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical…
Nov 20, 2023ResMed Ltd.DevicesMasks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical…
Nov 20, 2023ResMed Ltd.DevicesMasks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical…
Nov 20, 2023ROi CPS LLCDevicesROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the…
Nov 20, 2023Seneca Foods CorporationFoodUndeclared soy.
Nov 17, 2023FreshPoint Bix Produce Company, LLCFoodPotential Salmonella contamination.
Nov 17, 2023FreshPoint Bix Produce Company, LLCFoodPotential Salmonella contamination.
Nov 17, 2023FreshPoint Bix Produce Company, LLCFoodPotential Salmonella contamination.
Nov 17, 2023FreshPoint Bix Produce Company, LLCFoodPotential Salmonella contamination.
Nov 17, 2023FreshPoint Bix Produce Company, LLCFoodPotential Salmonella contamination.
Nov 17, 2023FreshPoint Bix Produce Company, LLCFoodPotential Salmonella contamination.
Nov 17, 2023FreshPoint Bix Produce Company, LLCFoodPotential Salmonella contamination.
Nov 17, 2023FreshPoint Bix Produce Company, LLCFoodPotential Salmonella contamination.
Nov 17, 2023FreshPoint DallasFoodTruFresh in Nogales, AZ issued a voluntary recall of its Malichita, Mexico-sourced whole cantaloupe sold in the United States for potential…
Nov 17, 2023InvaGen Pharmaceuticals, Inc.DrugsDefective Container: powder may leak out of the pouch
Nov 17, 2023Philips North America LlcDevicesFirm was informed of an event in which the structural integrity of the MR system components failed due to unintended excessive pressure…
Nov 17, 2023The HMC Group Marketing IncFoodPotential contamination with Listeria monocytogenes
Nov 17, 2023The HMC Group Marketing IncFoodPotential contamination with Listeria monocytogenes
Nov 17, 2023The HMC Group Marketing IncFoodPotential contamination with Listeria monocytogenes
Nov 17, 2023The HMC Group Marketing IncFoodPotential contamination with Listeria monocytogenes
Nov 17, 2023The HMC Group Marketing IncFoodPotential contamination with Listeria monocytogenes
Nov 17, 2023The HMC Group Marketing IncFoodPotential contamination with Listeria monocytogenes
Nov 17, 2023The HMC Group Marketing IncFoodPotential contamination with Listeria monocytogenes
Nov 17, 2023The HMC Group Marketing IncFoodPotential contamination with Listeria monocytogenes
Nov 17, 2023The HMC Group Marketing IncFoodPotential contamination with Listeria monocytogenes
Nov 17, 2023The HMC Group Marketing IncFoodPotential contamination with Listeria monocytogenes
Nov 17, 2023The HMC Group Marketing IncFoodPotential contamination with Listeria monocytogenes
Nov 15, 2023MEDLINE INDUSTRIES, LP - NorthfieldDevicesMedline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components)…
Nov 15, 2023MEDLINE INDUSTRIES, LP - NorthfieldDevicesMedline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components)…
Nov 15, 2023MEDLINE INDUSTRIES, LP - NorthfieldDevicesMedline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components)…
Nov 15, 2023MEDLINE INDUSTRIES, LP - NorthfieldDevicesMedline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components)…
Nov 15, 2023MEDLINE INDUSTRIES, LP - NorthfieldDevicesMedline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components)…

Showing the latest 100 of 253.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.