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FDA Warning Letters, 483s and Recalls: January 2024

FDA enforcement records dated January 2024: 24 warning letters outside tobacco (plus 18 tobacco letters), 34 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 31, 2024Barkey GmbH & Co. KGCenter for Biologics Evaluation and Research (CBER)Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Jan 31, 2024Les Importations Herbasanté Inc.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Jan 30, 2024Barsotti Juice Company, Inc.Division of Human and Animal Food Operations West VJuice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Jan 30, 2024Inmar Supply Chain Solutions, LLCDivision of Human and Animal Food Operations West IIICGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
Jan 29, 2024Knickerbocker 365, Inc.Division of Human and Animal Food Operations East VIFood Labeling/Misbranded
Jan 29, 2024Soulaire CorporationCenter for Devices and Radiological HealthInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Jan 26, 2024Agila Corporation Dba Woody’S Pet Food DeliDivision of Human and Animal Food Operations West ICGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated
Jan 26, 2024Lucky K.T. Co., Inc.Division of Human and Animal Food Operations West VCGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
Jan 26, 2024Nobles Medical Technology II, Inc.Center for Devices and Radiological HealthInvestigational Review Board (IRB)
Jan 26, 2024QuVa Pharma, Inc.Division of Pharmaceutical Quality Operations ICompounding Pharmacy/Adulterated Drug Products
Jan 26, 2024S & J International Enterprises Public Company LimitedCenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Jan 25, 2024Colgin, Inc.Division of Pharmaceutical Quality Operations IICGMP/Finished Pharmaceuticals/Adulterated
Jan 24, 2024Sambrosa Care Inc.Center for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Jan 23, 2024Mexpobaja CorporationDivision of West Coast ImportsForeign Supplier Verification Program (FSVP)
Jan 22, 2024Mei Lan Thailand Co., Ltd.Center for Drug Evaluation and Research | CDERCGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Refused Inspection
Jan 19, 2024Exactech, Inc.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Jan 16, 2024Glicerinas Industriales, S.A. De C.V.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Jan 8, 2024Comercializadora Internacional Piscicola New Your S.ACenter for Food Safety and Applied NutritionSeafood HACCP/CGMP for Foods/Adulterated
Jan 8, 2024Dr. Joel Kaplan Inc.Center for Devices and Radiological HealthQuality System Regulation for Medical Device Reporting/Adulterated/Misbranded
Jan 8, 2024Grace Supply Inc.Division of Southwest ImportsForeign Supplier Verification Program (FSVP)
Jan 8, 2024Korean Food, Inc.Division of Human and Animal Food Operations West IIICGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Misbranded
Jan 4, 2024Fresenius Kabi AGCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Jan 3, 2024ReConserve Inc.Division of Human and Animal Food Operations East IICGMP/Animal Food/Adulterated
Jan 2, 2024Prime Lab LLCOffice of Pharmaceutical QualityCGMP/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
Jan 31, 2024Baylab USA, LLCDevicesUnited States
Jan 31, 2024Ruth Special Food Store LLCFood/CosmeticsUnited States
Jan 29, 2024Genuine Virgin Aloe CorpDrugsUnited States
Jan 29, 2024SALEM Botanicals Corp.Food/CosmeticsUnited States
Jan 29, 2024TJA Health LLCDrugsUnited States
Jan 26, 2024FANCYSTAGE, UNIPESSOAL, LDA.DrugsPortugal
Jan 26, 2024HERBALAND NATURALS INCFood/CosmeticsCanada
Jan 26, 2024Optikem International, Inc.VeterinaryUnited States
Jan 26, 2024Specialty Process Labs LLCDrugsUnited States
Jan 25, 2024Harouts Inc.Food/CosmeticsUnited States
Jan 24, 2024F. Hunziker + Co. AGFood/CosmeticsSwitzerland
Jan 24, 2024Med Pen Concepts, LLCDevicesUnited States
Jan 23, 2024Swity D.O.O.Food/CosmeticsBosnia-Hercegovina
Jan 22, 2024AG Essence, Inc.DevicesUnited States
Jan 22, 2024Donggang Wanrui Food Co., Ltd.Food/CosmeticsChina
Jan 22, 2024Herbaland Naturals IncFood/CosmeticsCanada
Jan 22, 2024Kyokuyo Global Seafoods Co., Ltd.Food/CosmeticsThailand
Jan 22, 2024Lucero Produce II CorpFood/CosmeticsUnited States
Jan 22, 2024Omega Tech Labs, Inc.DrugsUnited States
Jan 22, 2024What The RawVeterinaryUnited States
Jan 19, 2024Brassica Pharma Private LtdDrugsIndia
Jan 19, 2024Dalian Lingfa Food Co., Ltd.Food/CosmeticsChina
Jan 19, 2024Meridian MadeFood/CosmeticsUnited States
Jan 19, 2024Thorn BioScience LLCVeterinaryUnited States
Jan 18, 2024Greenfruit Avocados, LLCFood/CosmeticsUnited States
Jan 18, 2024Little Moon Essentials LLCDrugsUnited States
Jan 18, 2024Session Supply CompanyTobaccoUnited States
Jan 16, 2024Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)DrugsChina
Jan 15, 2024HERBALAND NATURALS INCFood/CosmeticsCanada
Jan 12, 2024The Richline Group IncDevicesUnited States
Jan 11, 2024Reynolds Engineering & EquipmentDrugsUnited States
Jan 5, 2024Twillman Feed Service LLCVeterinaryUnited States
Jan 5, 2024Xo BiologixBiologicsUnited States
Jan 4, 2024Wagco Distribution IncTobaccoUnited 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 FSVP41
21 CFR 117.35(a)Sanitary operations - Plant sanitation22
21 CFR 820.198(a)Lack of or inadequate complaint procedures19
21 CFR 820.100(a)Lack of or inadequate procedures16
21 CFR 111.70(e)Specifications - identity, purity, strength, composition14
21 CFR 117.80(c)Manufacturing, processing, packing, holding - Controls13
21 CFR 211.22(d)Procedures not in writing, fully followed12
21 CFR 111.70(b)(2)Specifications-component purity, strength, composition11
21 CFR 117.130(a)(1)Hazard analysis - Identification of hazard11
21 CFR 117.135(a)(1)Sanitation preventive controls - Implement10

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, 2024Hearty Acquisitions LLCFoodProduct contains undeclared soy.
Jan 25, 2024MG Foods MiddletownFoodUndeclared egg
Jan 25, 2024UTZ QUALITY FOODS, LLCFoodProduct may contain undeclared milk.
Jan 23, 2024Fresenius Medical Care Holdings, Inc.DevicesThe peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Jan 23, 2024Fresenius Medical Care Holdings, Inc.DevicesThe peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Jan 23, 2024Fresenius Medical Care Holdings, Inc.DevicesThe peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Jan 23, 2024Fresenius Medical Care Holdings, Inc.DevicesThe peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Jan 23, 2024Fresenius Medical Care Holdings, Inc.DevicesThe peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Jan 23, 2024TRUONG GIANG WAREHOUSEFoodUndeclared sulfites
Jan 22, 2024Byrne Dairy, IncFoodcontains undeclared peanuts
Jan 22, 2024Medtronic NeurosurgeryDevicesPotential for catheter disconnection from the patient line stopcock connectors.
Jan 22, 2024Medtronic NeurosurgeryDevicesPotential for catheter disconnection from the patient line stopcock connectors.
Jan 22, 2024Medtronic NeurosurgeryDevicesPotential for catheter disconnection from the patient line stopcock connectors.
Jan 22, 2024Medtronic NeurosurgeryDevicesPotential for catheter disconnection from the patient line stopcock connectors.
Jan 22, 2024Medtronic NeurosurgeryDevicesPotential for catheter disconnection from the patient line stopcock connectors.
Jan 19, 2024Lydia Pack 3 IncFoodHummus product label declares Tahini but does not declare sesame.
Jan 19, 2024Lydia Pack 3 IncFoodHummus product label declares Tahini but does not declare sesame.
Jan 19, 2024Lydia Pack 3 IncFoodHummus product label declares Tahini but does not declare sesame.
Jan 17, 2024Hans Kissle Company, LLCFoodcontains undeclared soy and egg
Jan 16, 2024Avanos Medical, Inc.DevicesMIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
Jan 16, 2024Avanos Medical, Inc.DevicesMIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
Jan 12, 2024Neptune Resources, LLCDrugsMarketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Jan 12, 2024Neptune Resources, LLCDrugsMarketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Jan 12, 2024Neptune Resources, LLCDrugsMarketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Jan 11, 2024Rizo Lopez Foods, Inc. Dba Don Francisco CheeseFoodListeria monocytogenes contamination.
Jan 11, 2024Rizo Lopez Foods, Inc. Dba Don Francisco CheeseFoodListeria monocytogenes contamination.
Jan 11, 2024Rizo Lopez Foods, Inc. Dba Don Francisco CheeseFoodListeria monocytogenes contamination.
Jan 11, 2024Rizo Lopez Foods, Inc. Dba Don Francisco CheeseFoodListeria monocytogenes contamination.
Jan 11, 2024Rizo Lopez Foods, Inc. Dba Don Francisco CheeseFoodListeria monocytogenes contamination.
Jan 11, 2024Rizo Lopez Foods, Inc. Dba Don Francisco CheeseFoodListeria monocytogenes contamination.
Jan 11, 2024Rizo Lopez Foods, Inc. Dba Don Francisco CheeseFoodListeria monocytogenes contamination.
Jan 11, 2024Rizo Lopez Foods, Inc. Dba Don Francisco CheeseFoodListeria monocytogenes contamination.
Jan 11, 2024Rizo Lopez Foods, Inc. Dba Don Francisco CheeseFoodListeria monocytogenes contamination.
Jan 11, 2024Rizo Lopez Foods, Inc. Dba Don Francisco CheeseFoodListeria monocytogenes contamination.
Jan 11, 2024Rizo Lopez Foods, Inc. Dba Don Francisco CheeseFoodListeria monocytogenes contamination.
Jan 11, 2024Rizo Lopez Foods, Inc. Dba Don Francisco CheeseFoodListeria monocytogenes contamination.
Jan 11, 2024Rizo Lopez Foods, Inc. Dba Don Francisco CheeseFoodListeria monocytogenes contamination.
Jan 11, 2024Rizo Lopez Foods, Inc. Dba Don Francisco CheeseFoodListeria monocytogenes contamination.
Jan 10, 2024Big Island Candies, Inc.FoodWrong product in package; undeclared allergen (peanuts)
Jan 10, 2024Vyaire MedicalDevicesRisk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification…
Jan 10, 2024Vyaire MedicalDevicesRisk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification…
Jan 10, 2024Vyaire MedicalDevicesRisk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification…
Jan 10, 2024Vyaire MedicalDevicesRisk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification…
Jan 10, 2024Vyaire MedicalDevicesRisk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification…
Jan 10, 2024Vyaire MedicalDevicesRisk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification…
Jan 10, 2024Vyaire MedicalDevicesRisk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification…
Jan 10, 2024Vyaire MedicalDevicesRisk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification…
Jan 10, 2024Vyaire MedicalDevicesRisk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification…
Jan 9, 2024Ventec Life Systems, Inc.DevicesThe bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Detachment of the spiral wrap can compromise…
Jan 9, 2024Wegmans Food Markets, Inc.FoodProduct contains undeclared wheat.
Jan 6, 2024World Green Nutrition Inc.FoodFDA analysis found product labeled as tejocote is actually contains yellow oleander, which is toxic to humans.
Jan 4, 2024Azurity Pharmaceuticals, Inc.DrugsLabeling: Label Mix-up
Jan 4, 2024U.S. Tov, Inc.FoodPotential choking hazard; product contains konjac.
Jan 3, 2024Thoratec Corp.DevicesDue to software and controller systems that results in unexpected pump start or pump stop.

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.