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FDA Warning Letters, 483s and Recalls: January 2025

FDA enforcement records dated January 2025: 22 warning letters outside tobacco (plus 4 tobacco letters), 53 OAI inspections and 54 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
Jan 30, 2025Strukmyer LLC Dba Strukmyer MedicalCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jan 29, 2025AmWiner & Raphe Holdings, LLC Dba rapheGenerics CorpCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jan 28, 2025Elanco Animal HealthCenter for Veterinary MedicineFalse & Misleading Claims/Misbranded
Jan 28, 2025Rite-Kem IncorporatedCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jan 28, 2025Shantou Kangjie Daily Chemical Industry Co., LtdCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jan 27, 2025Garcia Fresh Vegetables LLCDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Jan 27, 2025Imperial Palace Commodity -Dongguan- Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jan 23, 2025Center For Instrumental Analysis Of China Pharmaceutical UniversityCenter for Drug Evaluation and Research (CDER)CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Jan 22, 2025Nubratori, Inc. Dba Nubratori RxCenter for Drug Evaluation and Research (CDER)Compounding Pharmacy/Adulterated Drug Products
Jan 21, 2025Kardesler Ucan Yaglar Sanayi Anonim SirketiCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceutical/Adulterated
Jan 21, 2025Robbins Instruments, LLC"ORP: Office of Regulatory Programs, Office of Product Evaluation and Quality"Medical Device/Misbranded/Unapproved Device/Quality System Regulation
Jan 17, 2025BioStem Life SciencesCenter for Biologics Evaluation and Research (CBER)Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Jan 17, 2025Chara Biologics, Inc.Center for Biologics Evaluation and Research (CBER)CGMP/Deviations/Biologics License Application (BLA)
Jan 16, 2025Global Calcium Pvt. LimitedCenter for Drug Evaluation and Research (CDER)CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Jan 16, 2025Mihon Corp. D/B/A VitalityVita And Boulla, LLCCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
Jan 16, 2025Yongdae Hwangtae Union Corp DaeryungHuman Foods ProgramSeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Jan 15, 2025SanofiCenter for Drug Evaluation and Research (CDER)CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Jan 14, 2025Radhaswamy Inc. Dba Raja Foods LLCDivision of Northeast ImportsForeign Supplier Verification Program (FSVP)
Jan 13, 2025Talla Imports, LLCOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
Jan 13, 2025Www.Weightcrunchshop.ComCenter for Drug Evaluation and Research (CDER)Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
Jan 8, 2025Atlanta Supersource, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jan 2, 2025Gongora USA CorpDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)

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
Jan 31, 2025Distillerie Stock Do Brasil LtdaFood/CosmeticsBrazil
Jan 31, 2025Philips Ultrasound, LLCDevicesUnited States
Jan 31, 2025Sky Nutro, LLCFood/CosmeticsUnited States
Jan 31, 2025Xtreme Tools International, IncDrugsUnited States
Jan 30, 20257 Daze LLCTobaccoUnited States
Jan 30, 2025Amsino Healthcare (USA) IncDrugsUnited States
Jan 30, 2025Riken Keiki Co., Ltd.DevicesJapan
Jan 29, 2025Toro Imports, LLCTobaccoUnited States
Jan 28, 2025FOUNDATION MEDICINE, INC.DevicesUnited States
Jan 28, 2025KMG-IMPORTS LLCTobaccoUnited States
Jan 27, 2025Insightra Medical IncDevicesUnited States
Jan 27, 2025M/S Svatv Herbs India Pvt. Ltd.Food/CosmeticsIndia
Jan 27, 2025Oasis Medical, Inc.DrugsUnited States
Jan 27, 2025ZACANTA LLCFood/CosmeticsUnited States
Jan 24, 2025Carolina Infusion, LLCDrugsUnited States
Jan 24, 2025HK INNO.N CORPORATIONDrugsKorea (the Republic of)
Jan 24, 2025P. Damodara Kumaran, M.D.DrugsIndia
Jan 24, 2025Raw Farm, LLCFood/CosmeticsUnited States
Jan 24, 2025Ridley USA IncVeterinaryUnited States
Jan 24, 2025SEDECAL SADevicesSpain
Jan 24, 2025Shiva Analyticals (India) Pvt. Ltd.DrugsIndia
Jan 24, 2025Turbare ManufacturingDrugsUnited States
Jan 24, 2025Zhejiang Huahai Pharmaceutical Co., Ltd.DrugsChina
Jan 23, 2025Aju Medical Co., Ltd.DevicesKorea (the Republic of)
Jan 23, 2025A.P. Deauville, LLCDrugsUnited States
Jan 23, 2025XPO HEALTH LIMITEDDevicesUnited Kingdom
Jan 22, 2025Artesanales P.R. LLCDrugsUnited States
Jan 21, 2025ES Food Industries Sdn BhdFood/CosmeticsMalaysia
Jan 21, 2025NATURE'S FUSIONS, LLCDrugsUnited States
Jan 21, 2025TruAbutment Inc.DevicesUnited States
Jan 21, 2025Vynacron Dental Resins, Inc.DevicesUnited States
Jan 17, 2025Advanced Cosmetic Research Laboratories, Inc.DrugsUnited States
Jan 17, 2025Black Note, Inc.TobaccoUnited States
Jan 17, 2025Philips Medical Systems Nederland B.V.DevicesNetherlands
Jan 17, 2025Private Label Partners, Inc.DrugsUnited States
Jan 17, 2025Sani-Care Salon Products, IncDrugsUnited States
Jan 17, 2025Wailea Agricultural Group IncFood/CosmeticsUnited States
Jan 17, 2025Walpole Feed & Supply, Co.VeterinaryUnited States
Jan 17, 2025Walpole Feed & Supply MillVeterinaryUnited States
Jan 16, 2025HORIZON TOOL INCDrugsUnited States
Jan 16, 2025Medline Industries, LPDrugsUnited States
Jan 15, 2025Daewoo Pharmaceutical Co., Ltd.DrugsKorea (the Republic of)
Jan 15, 2025Evi International Group, LLCDrugsUnited States
Jan 14, 2025Porttable Produtos Alimentares, Lda.Food/CosmeticsPortugal
Jan 13, 2025Respect Manufacturing CorporationDrugsUnited States
Jan 10, 2025Amish Origins Management, LLCDrugsUnited States
Jan 10, 2025Middle East/ Soli's Baking Company, Inc.Food/CosmeticsUnited States
Jan 10, 2025Prodrome Sciences USA, LLCDrugsUnited States
Jan 9, 2025DFI Co., Ltd.DevicesKorea (the Republic of)
Jan 9, 2025Kabe Labortechnik GmbhDevicesGermany
Jan 9, 2025Wardray Premise LtdDevicesUnited Kingdom
Jan 8, 2025Amor Nino Foods IncFood/CosmeticsUnited States
Jan 3, 2025Gate Gourmet, Inc.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)FSVP assurances31
21 CFR 211.22(d)Procedures not in writing, fully followed23
21 CFR 117.130(a)(1)Hazard analysis - Identification of hazard22
21 CFR 117.35(a)Sanitary operations - Plant sanitation22
21 CFR 211.192Written record of investigation incomplete19
21 CFR 117.135(a)(1)Sanitation preventive controls - Implement18
21 CFR 820.198(a)Lack of or inadequate complaint procedures18
21 CFR 820.100(a)Lack of or inadequate procedures17
21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved14
21 CFR 803.17Lack of Written MDR Procedures14

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
Jan 31, 2025Alvogen, IncDrugsDefective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Jan 31, 2025Nestle-USA, Inc. (Corporate Office)FoodFirm received complaints of infant choking.
Jan 31, 2025Nestle-USA, Inc. (Corporate Office)FoodFirm received complaints of infant choking.
Jan 31, 2025Turkana Food Inc.FoodProduct tested positive for Salmonella
Jan 30, 2025Micro Therapeutics, Inc.DevicesUse of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation…
Jan 30, 2025Micro Therapeutics, Inc.DevicesUse of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation…
Jan 28, 2025Ascent Consumer Products Inc.DrugsMicrobial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Jan 28, 2025Ascent Consumer Products Inc.DrugsMicrobial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Jan 28, 2025Ascent Consumer Products Inc.DrugsMicrobial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Jan 28, 2025FRESHPOINT CENTRAL FLORIDA, INC.FoodMislabeled salads (undeclared peanut allergen). Incorrect ingredient applied (peanuts)
Jan 27, 2025NEW YORK WHOLESALE GROUPFoodProduct contains elevated levels of lead - 6.50 mg/kg (ppm)
Jan 27, 2025United Natural Trading Inc. Dba Woodstock FarmsFoodUndeclared Allergen - Milk
Jan 25, 2025Amazon Retail LLCFoodUndeclared egg.
Jan 25, 2025Amazon Retail LLCFoodUndeclared egg.
Jan 22, 2025La Fiesta Food ProductsFoodFirm distributed a Seasoned Bread Crumb product with undeclared allergen (Sesame) not on the label.
Jan 22, 2025La Fiesta Food ProductsFoodFirm distributed a Bread Crumb product with undeclared allergen (Sesame) not on the label.
Jan 21, 2025Provepharm Inc.DrugsPresence of Particulate Matter.
Jan 19, 2025Arizona Foods Group, Inc.FoodProduct may contain egg, an undeclared allergen.
Jan 17, 2025PIU CHE DOLCI INC.FoodDue to potential Salmonella contamination
Jan 16, 2025Wismettac Asian Foods, Inc.FoodUndeclared allergen (Milk) in Shirakiku brand Curvee Puffs Corn Puff Snack
Jan 16, 2025Wismettac Asian Foods, Inc.FoodUndeclared allergen (Milk) in Shirakiku brand Curvee Puffs Corn Puff Snack
Jan 16, 2025Wismettac Asian Foods, Inc.FoodUndeclared allergen (Milk) in Shirakiku brand Curvee Puffs Corn Puff Snack
Jan 15, 2025AKT Trading Inc.FoodCHOSHIYA branded MENMA AJITSUKE PREPARED BAMBOO SHOOTS missing "Keep Refrigerated" statement on package and are not shelf stable.
Jan 15, 2025Getinge Usa Sales IncDevicesSevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers…
Jan 15, 2025Mutual Trading Company Inc.FoodImported Monkfish Liver undeclared allergen (Milk)
Jan 15, 2025Olympus Corporation Of The AmericasDevicesPotential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
Jan 14, 2025Frito-Lay, Inc. HeadquartersFoodUndeclared milk allergen
Jan 13, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.DevicesPossibility of the patient falling from the table related to the mattress used on the patient table.
Jan 13, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.DevicesPossibility of the patient falling from the table related to the mattress used on the patient table.
Jan 13, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.DevicesPossibility of the patient falling from the table related to the mattress used on the patient table.
Jan 13, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.DevicesPossibility of the patient falling from the table related to the mattress used on the patient table.
Jan 13, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.DevicesPossibility of the patient falling from the table related to the mattress used on the patient table.
Jan 13, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.DevicesPossibility of the patient falling from the table related to the mattress used on the patient table.
Jan 13, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.DevicesPossibility of the patient falling from the table related to the mattress used on the patient table.
Jan 13, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.DevicesPossibility of the patient falling from the table related to the mattress used on the patient table.
Jan 13, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.DevicesPossibility of the patient falling from the table related to the mattress used on the patient table.
Jan 13, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.DevicesPossibility of the patient falling from the table related to the mattress used on the patient table.
Jan 13, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.DevicesPossibility of the patient falling from the table related to the mattress used on the patient table.
Jan 13, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.DevicesPossibility of the patient falling from the table related to the mattress used on the patient table.
Jan 13, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.DevicesPossibility of the patient falling from the table related to the mattress used on the patient table.
Jan 13, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.DevicesPossibility of the patient falling from the table related to the mattress used on the patient table.
Jan 13, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.DevicesPossibility of the patient falling from the table related to the mattress used on the patient table.
Jan 13, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.DevicesPossibility of the patient falling from the table related to the mattress used on the patient table.
Jan 13, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.DevicesPossibility of the patient falling from the table related to the mattress used on the patient table.
Jan 13, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.DevicesPossibility of the patient falling from the table related to the mattress used on the patient table.
Jan 13, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.DevicesPossibility of the patient falling from the table related to the mattress used on the patient table.
Jan 13, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.DevicesPossibility of the patient falling from the table related to the mattress used on the patient table.
Jan 10, 2025Fresenius Kabi USA, LLCDevicesLarge Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if…
Jan 10, 2025Seoul Trading, Inc.FoodUndeclared peanut.
Jan 10, 2025Spectranetics CorporationDevicesUse of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to…
Jan 7, 2025Apna Wholesale Inc.FoodProduct contains undeclared sulfites (56.8mg/serving)
Jan 6, 2025The Mochi Ice Cream CompanyFoodFrozen Peach Mango Sorbet contains undeclared allergen (egg)
Jan 5, 2025Biosense Webster, Inc.DevicesDue to an observed trend of neurovascular events
Jan 3, 2025Middle East/ Soli's Baking Company, Inc. Dba Middle East Baking Co.FoodUndeclared milk

Check one company

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.