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FDA Warning Letters, 483s and Recalls: February 2024

FDA enforcement records dated February 2024: 30 warning letters outside tobacco (plus 12 tobacco letters), 41 OAI inspections and 109 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
Feb 29, 2024Cosmetic Specialty Labs, Inc.Division of Pharmaceutical Quality Operations IICGMP/Finished Pharmaceuticals/Adulterated
Feb 28, 2024Native Salts LLCCenter for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Feb 27, 2024Meditco, Inc. D.B.A. Phoenicia Specialty FoodsDivision of Southwest ImportsFSVP/Human and Animal Foods
Feb 27, 2024Thai Nakorn Patana Co., Ltd.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Feb 23, 2024Royal PhilipsCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Feb 22, 2024Always Fresco LLCDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Feb 22, 2024Higley Industries, Inc.Division of Pharmaceutical Quality Operations IIICGMP/Finished Pharmaceuticals/Adulterated
Feb 22, 2024Innovative Formulations, LLC Dba Insane LabzCenter for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Feb 15, 2024Bell International Laboratories, Inc.Division of Pharmaceutical Quality Operations IIICGMP/Finished Pharmaceuticals/Adulterated
Feb 15, 2024Dream Wholesale, IncDivision of Northern Border ImportsForeign Supplier Verification Program (FSVP)
Feb 15, 2024LightEyez LimitedCenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Feb 14, 2024Amman Pharmaceutical IndustriesCenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Feb 13, 2024Delsam Pharma LLCDivision of Pharmaceutical Quality Operations ICGMP/Finished Pharmaceuticals/Adulterated
Feb 13, 2024EzriCare LLCDivision of Pharmaceutical Quality Operations ICGMP/Finished Pharmaceuticals/Adulterated
Feb 13, 2024Salvacion USA Inc.Center for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded
Feb 9, 2024Empacadora Bilbo S.A. DBA BilbosaCenter for Food Safety and Applied NutritionSeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Feb 9, 2024Human MicrobesCenter for Biologics Evaluation and Research (CBER)CGMP/Deviations/Biologics License Application (BLA)
Feb 9, 2024Hunan Gagazui Food Co., Ltd.Center for Food Safety and Applied Nutrition (CFSAN)Low Acid Canned Food Regulation/Adulterated
Feb 9, 2024Ivsupplyclinic.ComCenter for Drug Evaluation and Research | CDERUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
Feb 9, 2024Pt Dua KelinciCenter for Food Safety and Applied NutritionCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Feb 9, 2024Zoet Poultry, Inc.Division of Human and Animal Food Operations East VIPHS Act/Shell Egg Regulation/Adulterated
Feb 7, 2024Synthetix Inc. DBA Helix Chemical SupplyCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded
Feb 7, 2024Trexo Robotics Holdings Inc."OHT5: Office of Neurological and Physical Medicine Devices, Office of Product Evaluation and Quality"Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device, Misbranded
Feb 7, 2024US Chem LabsCenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Feb 6, 2024Global Life Technologies Corp.Center for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded
Feb 5, 2024Ningbo Poplar Daily-UseCenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Feb 5, 2024Sichuan Deebio Pharmaceutical Co. Ltd.Center for Drug Evaluation and Research | CDERCGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Feb 2, 2024Ehy Holdings, LLCCenter for Drug Evaluation and Research | CDERFailure to Register and List
Feb 1, 2024Hi-Pro Feeds, LLCDivision of Human and Animal Food Operations West IIICGMP/Medicated Feeds/Adulterated
Feb 1, 2024Madhu Instruments Private LimitedCenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/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
Feb 29, 2024ECTO WorldTobaccoUnited States
Feb 29, 2024ISPE Produce Inc.Food/CosmeticsUnited States
Feb 29, 2024Magellan Technology IncTobaccoUnited States
Feb 29, 2024Shriram Institute For Industrial ResearchDrugsIndia
Feb 28, 2024New Mexico Lions Sight Conservation Foundation, Inc.BiologicsUnited States
Feb 27, 2024Accupack Midwest IncDrugsUnited States
Feb 27, 2024Warner Herb Co.Food/CosmeticsUnited States
Feb 26, 2024Choice All Natural Inc DDrugsUnited States
Feb 23, 2024Baja Best Distributing Inc.Food/CosmeticsUnited States
Feb 23, 2024Capital Imports LLCFood/CosmeticsUnited States
Feb 23, 2024Miramar Cosmetics, IncDrugsUnited States
Feb 22, 2024Barohup Inc.Food/CosmeticsUnited States
Feb 22, 2024Rash Catering Services, LLCFood/CosmeticsUnited States
Feb 22, 2024SZ Vape LLC D.B.A. Vype VaporTobaccoUnited States
Feb 21, 2024Haupt Pharma Latina SrlVeterinaryItaly
Feb 21, 2024Western Innovations, Inc.Food/CosmeticsUnited States
Feb 20, 2024Alfred Louie IncFood/CosmeticsUnited States
Feb 16, 2024Americo F. Padilla, MDDrugsUnited States
Feb 16, 2024Juice Roll Upz, Inc.TobaccoUnited States
Feb 16, 2024Nana Barseghian, M.D.DrugsUnited States
Feb 16, 2024OCALSA PRODUCE LLCFood/CosmeticsUnited States
Feb 16, 2024Penta Fine Ingredients, Inc.DrugsUnited States
Feb 14, 2024Sakhon Wattana (Thang Chue Hah)Food/CosmeticsThailand
Feb 14, 2024Tamara Fruit CJSCFood/CosmeticsArmenia
Feb 14, 2024Waiakea Bottling IncFood/CosmeticsUnited States
Feb 13, 2024Midway Co-Op AssociationVeterinaryUnited States
Feb 12, 2024Green Day Produce, Inc.Food/CosmeticsUnited States
Feb 12, 2024Stew Leonard's Holdings LLCFood/CosmeticsUnited States
Feb 9, 2024Baxter Healthcare CorporationDrugsUnited States
Feb 9, 2024Innotech Nutrition Solutions, Ltd.Food/CosmeticsCanada
Feb 9, 2024LiquidCapsule Manufacturing, LLCDrugsUnited States
Feb 9, 2024Mid America Pet Food LLCVeterinaryUnited States
Feb 9, 2024Nephron SC, LLCDrugsUnited States
Feb 8, 2024Chang & Son Enterprises, Inc.Food/CosmeticsUnited States
Feb 8, 2024GOLDEN NATURAL PRODUCTS INCFood/CosmeticsUnited States
Feb 8, 2024Park Avenue CompoundingDrugsUnited States
Feb 7, 2024Nutralab Canada Corp.Food/CosmeticsCanada
Feb 6, 2024Ocho Rios Atlanta Inc.Food/CosmeticsUnited States
Feb 2, 2024Eugia Pharma Specialities LimitedDrugsIndia
Feb 2, 2024JUQUILITA MEXICAN IMPORTS LLCFood/CosmeticsUnited States
Feb 2, 2024The Quaker Oats Co.Food/CosmeticsUnited States

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 FSVP48
21 CFR 117.35(a)Sanitary operations - Plant sanitation27
21 CFR 117.10Personnel23
21 CFR 117.130(a)(1)Hazard analysis - Identification of hazard17
21 CFR 117.80(c)Manufacturing, processing, packing, holding - Controls16
21 CFR 820.100(a)Lack of or inadequate procedures16
21 CFR 1.505(a)(2)Evaluation - performance, risk15
21 CFR 211.22(d)Procedures not in writing, fully followed14
21 CFR 111.70(e)Specifications - identity, purity, strength, composition13
21 CFR 117.135(a)(1)Process preventive controls - Implement13

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
Feb 27, 2024Roland Foods, LLC.FoodProduct may be contaminated with Salmonella.
Feb 27, 2024Smiths Medical ASD Inc.DevicesCADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Upstream Occlusion, 2. Stop and…
Feb 27, 2024Smiths Medical ASD Inc.DevicesThe CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous…
Feb 27, 2024Smiths Medical ASD Inc.DevicesThe CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous…
Feb 27, 2024T Marzetti CoFoodUndeclared Allergens - Wheat and Soy
Feb 26, 2024MEDLINE INDUSTRIES, LP - NorthfieldDevicesComplaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture…
Feb 23, 2024Backstage Center DBA CTC SellerFoodThe "Alipotec King" Alipotec Raiz de Tejocote product was found to contain toxic yellow oleander instead of tejocote.
Feb 21, 2024InfuTronix LLCDevicesInfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure modes, including battery failure…
Feb 21, 2024InfuTronix LLCDevicesInfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure modes, including battery failure…
Feb 20, 2024Boston Scientific CorporationDevicesAn investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding…
Feb 20, 2024LQNN Inc.FoodUndeclared allergen; egg
Feb 20, 2024LQNN Inc.FoodUndeclared allergen; egg
Feb 20, 2024LQNN Inc.FoodUndeclared allergen; egg
Feb 20, 2024LQNN Inc.FoodUndeclared allergen; egg
Feb 20, 2024LQNN Inc.FoodUndeclared allergen; egg
Feb 20, 2024LQNN Inc.FoodUndeclared allergen; egg
Feb 20, 2024LQNN Inc.FoodUndeclared allergen; egg
Feb 20, 2024LQNN Inc.FoodUndeclared allergen; egg
Feb 20, 2024LQNN Inc.FoodUndeclared allergen; egg
Feb 20, 2024LQNN Inc.FoodUndeclared allergen; egg
Feb 20, 2024LQNN Inc.FoodUndeclared allergen; egg
Feb 20, 2024LQNN Inc.FoodUndeclared allergen; egg
Feb 19, 2024Thoratec Corp.DevicesObserved outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
Feb 19, 2024Thoratec Corp.DevicesObserved outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
Feb 16, 2024Raw Farm LLCFoodPotential contamination with E. coli O157:H7
Feb 16, 2024Raw Farm LLCFoodPotential contamination with E. coli O157:H7
Feb 16, 2024Raw Farm LLCFoodPotential contamination with E. coli O157:H7
Feb 15, 2024Eugia US LLCDrugsPresence of Particulate Matter
Feb 14, 2024Capitol Commissary LLCFoodUndeclared sesame.
Feb 14, 2024Capitol Commissary LLCFoodUndeclared sesame.
Feb 14, 2024Woolery Enterprises, Inc. Dba Will's Fresh FoodsFoodL. mono contamination
Feb 13, 2024DeRoyal Industries IncDevicesDeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently…
Feb 12, 2024ARROW INTERNATIONAL Inc.DevicesTeleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective…
Feb 12, 2024Boston Scientific CorporationDevicesBoston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft…
Feb 12, 2024FA Online IncDrugsMarketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for…
Feb 9, 2024COMPASS GROUP USA, INC.FoodListeria monocytogenes. The recalled Cotija cheese was repackaged into finished RTE Sprig and Sprout Ham and Cotija Torta Sandwich on…
Feb 9, 2024HandNaturalFoodProduct recalled due to the presence of yellow oleander and its components in the product.
Feb 9, 2024HandNaturalFoodProduct recalled due to the presence of yellow oleander and its components in the product.
Feb 9, 2024HandNaturalFoodProduct recalled due to the presence of yellow oleander and its components in the product.
Feb 9, 2024HandNaturalFoodProduct recalled due to the presence of yellow oleander and its components in the product.
Feb 9, 2024HandNaturalFoodProduct is being recalled due to the presence of yellow oleander and its components in the product.
Feb 9, 2024HandNaturalFoodProduct recalled due to the presence of yellow oleander and its components in the product.
Feb 9, 2024HandNaturalFoodProduct recalled due to the presence of yellow oleander and its components in the product.
Feb 9, 2024HandNaturalFoodProduct recalled due to the presence of yellow oleander and its components in the product.
Feb 9, 2024HandNaturalFoodProduct recalled due to the presence of yellow oleander and its components in the product.
Feb 9, 2024HandNaturalFoodProduct recalled due to the presence of yellow oleander and its components in the product.
Feb 9, 2024HandNaturalFoodProduct recalled due to the presence of yellow oleander and its components in the product.
Feb 9, 2024HandNaturalFoodProduct recalled due to the presence of yellow oleander and its components in the product.
Feb 9, 2024HandNaturalFoodProduct recalled due to the presence of yellow oleander and its components in the product.
Feb 9, 2024HandNaturalFoodProduct recalled due to the presence of yellow oleander and its components in the product.
Feb 9, 2024HandNaturalFoodProduct recalled due to the presence of yellow oleander and its components in the product.
Feb 8, 2024Dole Fresh Vegetables IncFoodProduct has the potential to be contaminated with Listeria monocytogenes.
Feb 8, 2024Dole Fresh Vegetables IncFoodProduct has the potential to be contaminated with Listeria monocytogenes.
Feb 8, 2024Dole Fresh Vegetables IncFoodProduct has the potential to be contaminated with Listeria monocytogenes.
Feb 8, 2024Dole Fresh Vegetables IncFoodProduct has the potential to be contaminated with Listeria monocytogenes.
Feb 8, 2024Dole Fresh Vegetables IncFoodProduct has the potential to be contaminated with Listeria monocytogenes.
Feb 8, 2024Fresh Express IncorpatedFoodProduct has the potential to be contaminated with Listeria monocytogenes. The condiment pack in the salad kit contains cheese recalled by…
Feb 8, 2024Fresh Express IncorpatedFoodProduct has the potential to be contaminated with Listeria monocytogenes. The condiment pack in the salad kit contains cheese recalled by…
Feb 8, 2024Ready Pac Foods IncFoodProduct has the potential to be contaminated with Listeria monocytogenes.
Feb 8, 2024Ready Pac Foods IncFoodProduct has the potential to be contaminated with Listeria monocytogenes.
Feb 8, 2024Ready Pac Foods IncFoodProduct has the potential to be contaminated with Listeria monocytogenes.
Feb 8, 2024Ready Pac Foods IncFoodProduct has the potential to be contaminated with Listeria monocytogenes.
Feb 7, 2024Braga Ranch INC.FoodProduct has the potential to be contaminated with Listeria monocytogenes.
Feb 7, 2024BrightFarmsFoodProduct ingredient may be contaminated with Listeria monocytogenes.
Feb 7, 2024FGP Manufacturing, LLCFoodUndeclared Allergens - Egg
Feb 7, 2024Smiths Medical ASD Inc.DevicesWhen a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous…
Feb 7, 2024Smiths Medical ASD Inc.DevicesWhen a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous…
Feb 7, 2024Taylor Fresh Foods IncFoodProduct has the potential to be contaminated with Listeria monocytogenes.
Feb 7, 2024Taylor Fresh Foods IncFoodProduct has the potential to be contaminated with Listeria monocytogenes.
Feb 7, 2024The Fierro Group Inc. Dba Rico BrandsFoodFirm is recalling enchiladas made with Queso Fresno cheese due to the potential contamination with Listeria monocytogenes.
Feb 7, 2024The Fierro Group Inc. Dba Rico BrandsFoodFirm is recalling enchiladas made with Queso Fresno cheese due to the potential contamination with Listeria monocytogenes.
Feb 7, 2024The Fierro Group Inc. Dba Rico BrandsFoodFirm is recalling enchiladas made with Queso Fresno cheese due to the potential contamination with Listeria monocytogenes.
Feb 7, 2024The Fierro Group Inc. Dba Rico BrandsFoodFirm is recalling enchiladas made with Queso Fresno cheese due to the potential contamination with Listeria monocytogenes.
Feb 7, 2024Trader Joe's CompanyFoodL. mono contamination
Feb 7, 2024Trader Joe's CompanyFoodL. mono contamination
Feb 7, 2024Trader Joe's CompanyFoodL. mono contamination
Feb 6, 2024Fresh & Ready Foods LLCFoodL. mono contamination
Feb 6, 2024Fresh & Ready Foods LLCFoodL. mono contamination
Feb 6, 2024Fresh & Ready Foods LLCFoodL. mono contamination
Feb 6, 2024Fresh & Ready Foods LLCFoodL. mono contamination
Feb 6, 2024Lakeview Farms LLCFoodPotential contamination of Listeria monocytogenes
Feb 6, 2024Reser's Fine Foods, Inc.FoodListeria monocytogenes. The recalled Cotija cheese was repackaged into finished wholesale and retail RTE products.
Feb 6, 2024Reser's Fine Foods, Inc.FoodListeria monocytogenes. The recalled Cotija cheese was repackaged into finished wholesale and retail RTE products.
Feb 6, 2024Reser's Fine Foods, Inc.FoodListeria monocytogenes. The recalled Cotija cheese was repackaged into finished wholesale and retail RTE products.
Feb 6, 2024Reser's Fine Foods, Inc.FoodListeria monocytogenes. The recalled Cotija cheese was repackaged into finished wholesale and retail RTE products.
Feb 6, 2024Reser's Fine Foods, Inc.FoodListeria monocytogenes. The recalled Cotija cheese was repackaged into finished wholesale and retail RTE products.
Feb 6, 2024Reser's Fine Foods, Inc.FoodListeria monocytogenes. The recalled Cotija cheese was repackaged into finished wholesale and retail RTE products.
Feb 6, 2024Today The WorldDrugsMarketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA…
Feb 6, 2024Today The WorldDrugsMarketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in…
Feb 6, 2024Today The WorldDrugsMarketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in…
Feb 5, 2024Castle Importing, Inc.FoodProduct has the potential to be contaminated with Listeria monocytogenes.
Feb 5, 2024Castle Importing, Inc.FoodProduct has the potential to be contaminated with Listeria monocytogenes.
Feb 5, 2024Sargento Foods, Inc.FoodListeria monocytogenes
Feb 5, 2024Sargento Foods, Inc.FoodListeria monocytogenes
Feb 5, 2024Sargento Foods, Inc.FoodListeria monocytogenes
Feb 5, 2024Sargento Foods, Inc.FoodListeria monocytogenes
Feb 5, 2024Sargento Foods, Inc.FoodListeria monocytogenes
Feb 5, 2024Sargento Foods, Inc.FoodListeria monocytogenes
Feb 5, 2024Sargento Foods, Inc.FoodListeria monocytogenes
Feb 5, 2024Sargento Foods, Inc.FoodListeria monocytogenes

Showing the latest 100 of 109.

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