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FDA Warning Letters, 483s and Recalls: December 2024

FDA enforcement records dated December 2024: 38 warning letters outside tobacco (plus 11 tobacco letters), 32 OAI inspections and 77 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
Dec 30, 2024Evolutionary Biologics Inc.Center for Biologics Evaluation and ResearchDeviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Dec 26, 2024Baldwin Richardson Foods Pennsauken, LLCHuman Foods ProgramLow Acid Canned Food Regulation/Adulterated
Dec 26, 2024Kingdom Creamery Of Vermont LLCHuman Foods ProgramCGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
Dec 26, 2024Reunipeche SASHuman Foods ProgramSeafood HACCP/CGMP for Foods/Adulterated
Dec 23, 2024By George Food Specialties Inc.Division of Northern Border ImportsForeign Supplier Verification Program (FSVP)
Dec 23, 2024Guangzhou Sinocon Food Co., LtdHuman Foods ProgramCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Dec 23, 2024Nyumbani Hakuna Matata LLCDivision of Northern Border ImportsSeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Dec 23, 2024Rey De Los Camarones S. A.Human Foods ProgramSeafood HACCP/CGMP for Foods/Adulterated
Dec 20, 2024Golden Grains BakeryHuman Foods ProgramCGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
Dec 19, 2024Fagron Compounding Services, LLC Dba Fagron Sterile ServiceCenter for Drug Evaluation and Research (CDER)Compounding Pharmacy/Adulterated Drug Products
Dec 19, 2024Integra LifeSciences CorporationCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Dec 19, 2024Viatris, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Dec 18, 2024Bhargava Phytolab Private LimitedCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceutical/API/Adulterated
Dec 18, 2024COFISA - Conservas De Peixe Da Figueira, S.A.Human Foods ProgramSeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Dec 18, 2024Hologic, Inc.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated/Misbranded
Dec 18, 2024Premium Fresh Growers LLCDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Dec 18, 2024Sombra Cosmetics, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Dec 17, 2024Akron Formulations India Private LimitedCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceutical/Adulterated
Dec 17, 2024Anne’S Daye Ltd Dba Tampon InnovationsCenter for Devices and Radiological HealthInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Dec 17, 2024Brands International CorporationCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceutical/Adulterated/Refusal to Allow Inspection
Dec 17, 2024Loyd Sanabria Hernandez Dba Avicola Santa FeHuman Foods ProgramPHS Act/Shell Egg Regulation/Adulterated
Dec 17, 2024Right Value Drug Stores, LLC Dba Carie Boyd PharmaceuticalsCenter for Drug Evaluation and Research (CDER)Compounding Pharmacy/Adulterated Drug Products
Dec 16, 2024Indoco Remedies LimitedCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Dec 16, 2024Skye Biologics Holdings LLCCenter for Biologics Evaluation and Research (CBER)Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Dec 12, 2024INCELL Corporation LLCCenter for Biologics Evaluation and Research (CBER)CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Dec 12, 2024XO Biologix, LLCCenter for Biologics Evaluation and Research (CBER)Unapproved New Drugs/Adulterated
Dec 10, 2024Prime Vitality, Inc. Dba Prime PeptidesCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
Dec 10, 2024Summit Research PeptidesCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
Dec 10, 2024SwisschemsCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
Dec 10, 2024VeronvyCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
Dec 10, 2024Xcel Research LLCCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
Dec 9, 2024Phillips Precision, Inc.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Dec 9, 2024Xoran Technologies, LLCCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated/Misbranded
Dec 6, 2024Randox Laboratories LimitedCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Dec 4, 2024Candymar Produce IncDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Dec 3, 2024Applied Therapeutics, Inc.Center for Drug Evaluation and Research (CDER)Sponsor
Dec 3, 2024Han C. Phan, M.D.Center for Drug Evaluation and Research (CDER)Clinical Investigator
Dec 3, 2024Micro Orgo ChemCenter for Drug Evaluation and Research (CDER)CGMP/Active Pharmaceutical Ingredient (API)/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
Dec 31, 2024CTK OTC Laboratories LLCDrugsUnited States
Dec 20, 2024Elemental Herbs, Inc.DrugsUnited States
Dec 20, 2024Healwell Homeo Private LimitedDrugsIndia
Dec 20, 2024RESET TECHNOLOGY CORPORATIONDevicesUnited States
Dec 20, 2024Vidaslim Co.Food/CosmeticsUnited States
Dec 19, 2024Chartwell Pharmaceuticals Congers, LLCDrugsUnited States
Dec 19, 2024Time Challenger Labs International Inc.Food/CosmeticsUnited States
Dec 17, 2024Gonzar Produce, LLCFood/CosmeticsUnited States
Dec 13, 2024Lasetech LLCDevicesUnited States
Dec 13, 2024Quali ControleDrugsFrance
Dec 13, 2024Vantive Manufacturing Pte. Ltd.DrugsSingapore
Dec 12, 2024DO & CO New York Catering, Inc.Food/CosmeticsUnited States
Dec 12, 2024Jamol Laboratories, Inc.DrugsUnited States
Dec 12, 2024Sobaek Insam Farming AssociationFood/CosmeticsKorea (the Republic of)
Dec 11, 2024KENIL HEALTHCARE PRIVATE LIMITEDDrugsIndia
Dec 11, 2024Rash Catering Services, LLCFood/CosmeticsUnited States
Dec 10, 2024Tradewind Foods, Inc.Food/CosmeticsUnited States
Dec 10, 2024Trivelli Tartufi, SrlFood/CosmeticsItaly
Dec 9, 2024One Roof LLCFood/CosmeticsUnited States
Dec 6, 2024Dynamic Blending Specialists, Inc.DrugsUnited States
Dec 6, 2024Nestor Reyes Farm & Associates Inc.Food/CosmeticsUnited States
Dec 6, 2024Ralph A DeFronzo, MDDrugsUnited States
Dec 5, 2024Hindustan Mint & Agro Products Private LtdDrugsIndia
Dec 5, 2024J. D. Heiskell Holdings LLCVeterinaryUnited States
Dec 5, 2024PT. Anugrah Laut IndonesiaFood/CosmeticsIndonesia
Dec 5, 2024Soulaire CorporationDevicesUnited States
Dec 5, 2024Vivant Skin Care, LLCDrugsUnited States
Dec 4, 2024Gold Bond Inc.DrugsUnited States
Dec 4, 2024Okami Medical Inc.DevicesUnited States
Dec 3, 2024Garcia Fresh Vegetables LLCFood/CosmeticsUnited States
Dec 3, 2024LW Chemicals IncDrugsUnited States
Dec 3, 2024Vantive Manufacturing (Thailand) CompanyDrugsThailand

Most-cited Form 483 sections

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

CFR sectionObservationCitations
21 CFR 117.135(a)(1)Sanitation preventive controls - Implement31
21 CFR 1.502(a)Develop FSVP29
21 CFR 117.35(a)Sanitary operations - Plant sanitation27
21 CFR 117.130(a)(1)Hazard analysis - Identification of hazard22
21 CFR 117.10Personnel16
21 CFR 117.35(c)Pest control15
21 CFR 820.100(a)Lack of or inadequate procedures15
21 CFR 820.198(a)Lack of or inadequate complaint procedures14
21 CFR 117.20(b)Plant construction and design13
21 CFR 117.35(d)Sanitation of food-contact surfaces - Frequency13

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
Dec 31, 2024MEDLINE INDUSTRIES, LP - NorthfieldDevicesThe catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
Dec 31, 2024MEDLINE INDUSTRIES, LP - NorthfieldDevicesThe catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
Dec 27, 2024Braga Fresh Foods LLCFoodPotential contamination with Listeria monocytogenes.
Dec 26, 2024ROi CPS LLCDevicesThere is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in…
Dec 23, 2024Astellas Pharma US Inc.DrugsFailed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Dec 23, 2024Astellas Pharma US Inc.DrugsFailed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Dec 23, 2024Percussionaire CorporationDevicesDue to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction…
Dec 20, 2024Baxter Healthcare CorporationDevicesThere is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the…
Dec 20, 2024Baxter Healthcare CorporationDevicesThere is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the…
Dec 20, 2024Baxter Healthcare CorporationDevicesThere is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the…
Dec 20, 2024Baxter Healthcare CorporationDevicesThere is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the…
Dec 20, 2024ENDO USA, Inc.DrugsLabeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine…
Dec 20, 2024Max Mobility LLCDevicesDue to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of…
Dec 20, 2024Max Mobility LLCDevicesDue to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of…
Dec 18, 2024Abbey Specialty FoodsFoodProduct may have Listeria Monocytogenes.
Dec 18, 2024Abbey Specialty FoodsFoodProduct may have Listeria Monocytogenes.
Dec 18, 2024Alcon Research LLCDrugsNon-Sterility
Dec 18, 2024Braemar Manufacturing, LLCDevicesNot all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis…
Dec 18, 2024Olympus Corporation Of The AmericasDevicesPotential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely…
Dec 17, 2024Orgain, LLCFoodPotential contamination of undeclared allergen peanuts
Dec 16, 2024MEDLINE INDUSTRIES, LP - NorthfieldDevicesFluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro…
Dec 16, 2024MEDLINE INDUSTRIES, LP - NorthfieldDevicesFluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro…
Dec 16, 2024Pinsarella Food LLCFoodUndeclared allergens (Wheat and Soy)
Dec 16, 2024SHOPPERS- PLAZADrugsMarketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
Dec 13, 2024Frito Lay IncFoodUndeclared Milk Allergen
Dec 12, 2024Abiomed, Inc.DevicesOptical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not…
Dec 12, 2024Abiomed, Inc.DevicesOptical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not…
Dec 12, 2024Boston Scientific CorporationDevicesA subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate…
Dec 12, 2024Boston Scientific CorporationDevicesA subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate…
Dec 12, 2024Boston Scientific CorporationDevicesA subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate…
Dec 12, 2024Boston Scientific CorporationDevicesA subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate…
Dec 12, 2024Boston Scientific CorporationDevicesA subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate…
Dec 12, 2024Boston Scientific CorporationDevicesA subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate…
Dec 12, 2024Buy-HerbalDrugsMarketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and…
Dec 12, 2024COREPACK MANUFACTURING INCFoodPossible Salmonella contamination of affected product.
Dec 12, 2024GNMart LLCDrugsMarketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
Dec 12, 2024WHOLESALE PRODUCE SUPPLY LLC DBAFoodCucumbers may be contaminated with Salmonella.
Dec 11, 2024New Age International, Inc.Foodmay be contaminated with Listeria monocytogenes
Dec 11, 2024Nuwellis IncDevicesThe AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate "Ultrafiltrate…
Dec 11, 2024Vidaslim Co.FoodDue to the presence of Toxic yellow oleander
Dec 10, 2024C.H. Guenther & Son, Inc.FoodUndeclared egg allergen
Dec 10, 2024GARDNER'S CANDIES , INCFoodProduct contains Undeclared Allergen Tree Nuts (Cashews)
Dec 10, 2024Mercury Enterprises, Inc. Dba Mercury MedicalDevicesGas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not…
Dec 9, 2024JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTDDevicesOxygen concentrator may melt or catch on fire during use.
Dec 9, 2024Maquet Cardiovascular, LLCDevicesPotential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
Dec 9, 2024Maquet Cardiovascular, LLCDevicesPotential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
Dec 6, 2024Cal Yee Farm LLCFoodUndeclared milk
Dec 6, 2024Cal Yee Farm LLCFoodUndeclared milk
Dec 6, 2024Cal Yee Farm LLCFoodUndeclared milk
Dec 6, 2024Cal Yee Farm LLCFoodUndeclared milk
Dec 6, 2024Cal Yee Farm LLCFoodUndeclared wheat, Undeclared soybean oil
Dec 6, 2024Cal Yee Farm LLCFoodUndeclared milk
Dec 6, 2024Cal Yee Farm LLCFoodUndeclared milk
Dec 6, 2024Cal Yee Farm LLCFoodUndeclared wheat, Undeclared soybean oil
Dec 6, 2024Fresenius Kabi USA, LLCDevicesPotential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
Dec 6, 2024Heber Valley Artisan Cheese, LLC.FoodThe Cascade Raw Cheddar Cheese was recalled due to Shiga toxin-producing E. coli (STEC) and elevated generic E.coli in finished product…
Dec 6, 2024Reser's Fine Foods, Inc.FoodSalmonella. Item 404885, Gyro Kit No Trays contains implicated cucumber in the tzatziki sauce cup.
Dec 6, 2024Reser's Fine Foods, Inc.FoodSalmonella. Beef & Lamb Gyro Sandwich Express Meal Kit contains implicated cucumber in the tzatziki sauce 3oz. cup.
Dec 6, 2024Reser's Fine Foods, Inc.FoodSalmonella. Item 404884, Gyro Kit With Trays contains implicated cucumber in the tzatziki sauce 2oz. cup.
Dec 6, 2024Sprouts Farmers MarketFoodCucumbers from Baloian Farms in tzatziki sauce have the potential to be contaminated with Salmonella.
Dec 5, 2024Atkinson Milling CompanyFoodUndeclared Milk. During the firm's reordering process of labels, they discovered that the label does not list milk in its ingredient or…
Dec 5, 2024Atkinson Milling CompanyFoodUndeclared Milk. During the firm's reordering process of labels, they discovered that the label does not list milk in its ingredient or…
Dec 5, 2024Field Fresh Foods, Inc.FoodCucumbers possibly contaminated with Salmonella; associated with outbreak
Dec 5, 2024F&S Produce West LLCFoodMediterranean party tray contains tzatziki sauce made with potentially contaminated (Salmonella) cucumbers.
Dec 2, 2024CORFU TASTY GYROSFoodPotential for Salmonella
Dec 2, 2024First Quality ProduceFoodPotential contamination with Salmonella.
Dec 2, 2024First Quality ProduceFoodPotential contamination with Salmonella.
Dec 2, 2024First Quality ProduceFoodPotential contamination with Salmonella.
Dec 2, 2024First Quality ProduceFoodPotential contamination with Salmonella.
Dec 2, 2024Grecian Delight/KronosFoodpotential for salmonella
Dec 2, 2024Grecian Delight/KronosFoodpotential for salmonella
Dec 2, 2024Grecian Delight/KronosFoodpotential for salmonella
Dec 1, 2024RUSS DAVIS WHOLESALEFoodCucumbers have potential to be contaminated with Salmonella.
Dec 1, 2024RUSS DAVIS WHOLESALEFoodCucumbers have potential to be contaminated with Salmonella.
Dec 1, 2024RUSS DAVIS WHOLESALEFoodCucumbers have potential to be contaminated with Salmonella.
Dec 1, 2024RUSS DAVIS WHOLESALEFoodCucumbers have potential to be contaminated with Salmonella.
Dec 1, 2024RUSS DAVIS WHOLESALEFoodCucumbers have potential to be contaminated with Salmonella.

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See one company's full record with the free FDA compliance check, or search warning letters and Form 483 citations by name.

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