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FDA Warning Letters, 483s and Recalls: December 2023

FDA enforcement records dated December 2023: 27 warning letters outside tobacco (plus 20 tobacco letters), 35 OAI inspections and 136 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 28, 2023Woorilife & HealthCenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Dec 26, 2023Techlem Medical CorporationCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated/Misbranded
Dec 22, 2023East Fork CultivarsOffice of Unapproved Drugs and Labeling ComplianceFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Dec 21, 2023Botanical BeCenter for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Dec 21, 2023Curtis Jacquot Dba Pacific BioLogic Co.Division of Human and Animal Food Operations West VCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Dec 21, 2023Wipro Unza Singapore Private, LimitedDrugRefusal to Provide Access to and Copying of Records
Dec 20, 2023Amazon.Com, Inc.Center for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Dec 20, 2023Hua Da Trading, Inc.Center for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Dec 20, 2023MiMedx Group, Inc.Center for Biologics Evaluation and Research (CBER)Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Dec 20, 2023Samuel Rodriguez Dba KiloKennelzzCenter for Veterinary MedicineUnapproved New Animal Drug/Adulterated
Dec 19, 2023Jeffrey W. Taub, M.D./Children's Hospital Of MichiganCenter for Drug Evaluation and Research | CDERClinical Investigator
Dec 18, 2023A True Move LLCDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Dec 15, 2023Inopak, Ltd.Division of Pharmaceutical Quality Operations ICGMP/Finished Pharmaceuticals/Adulterated
Dec 15, 2023Iowa Egg Company Inc.Division of Human and Animal Food Operations West IIPHS Act/Shell Egg Regulation/Adulterated
Dec 15, 2023Patcos Cosmetics Pvt. Ltd.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Dec 14, 2023Www.Trinexpharmacy.ComCenter for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Dec 12, 2023Anish S. Shah, M.D./Siyan Clinical ResearchCenter for Drug Evaluation and Research | CDERClinical Investigator
Dec 12, 2023Omeza LLCOffice of Pharmaceutical QualityCGMP/Finished Pharmaceuticals/Adulterated
Dec 7, 2023Dextrum Laboratories Inc.Division of Pharmaceutical Quality Operations IICGMP/Finished Pharmaceuticals/Adulterated
Dec 7, 2023Novid Group, Inc.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated/Misbranded
Dec 5, 2023Ambaya Gold Health Products, LLCDivision of Human and Animal Food Operations West IVUnapproved New Drugs/Misbranded
Dec 5, 2023Colonial Dames Company, LtdDivision of Pharmaceutical Quality Operations IVCGMP/Finished Pharmaceuticals/Adulterated
Dec 5, 2023US Gulf Coast Trading Co., Inc.Division of Human and Animal Food Operations West IIICGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Dec 4, 2023Fresenius Medical Care AG & Co. KGaACenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Dec 4, 2023Ostar Beauty Sci-Tech Co Ltd.OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and QualityInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Dec 1, 2023Belmont Eyecare LLCCenter for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug
Dec 1, 2023JJR Global Inc.Division 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
Dec 22, 2023Texas Farm Products CompanyVeterinaryUnited States
Dec 21, 2023New India Bazar, Inc.Food/CosmeticsUnited States
Dec 21, 2023Ocean Group Inc.Food/CosmeticsUnited States
Dec 21, 2023YAHON ENTERPRISE CO., LTDDrugsVietnam
Dec 20, 2023Cardinal Health 200, LLCDevicesUnited States
Dec 20, 2023Top Private Label Co.Food/CosmeticsUnited States
Dec 19, 2023Bolger & O'Hearn IncDrugsUnited States
Dec 18, 2023Aerosol And Liquid Packaging, Inc.DrugsUnited States
Dec 18, 2023Bimeda Pomona Inc.VeterinaryUnited States
Dec 15, 2023AKT Trading Inc.Food/CosmeticsUnited States
Dec 15, 2023Blaine Labs IncDrugsUnited States
Dec 15, 2023Pillar5 Pharma Inc.DrugsCanada
Dec 14, 2023Amplivox LtdDevicesUnited Kingdom
Dec 14, 2023AUSTROFOOD S.A.S.Food/CosmeticsEcuador
Dec 14, 2023Landy InternationalDrugsChina
Dec 14, 2023Rex ImplantsDevicesUnited States
Dec 14, 2023STG24 CO.,LTD.DevicesKorea (the Republic of)
Dec 14, 2023Velocity Pharma LLCDrugsUnited States
Dec 13, 2023Genpro Import & Export Inc.Food/CosmeticsUnited States
Dec 13, 2023Michelson Diagnostics LtdDevicesUnited Kingdom
Dec 12, 2023Alpha AromaticsDrugsUnited States
Dec 12, 2023Golden Shrimp Seafood Joint Stock CompanyFood/CosmeticsVietnam
Dec 12, 2023Laurus Synthesis Private LimitedDrugsIndia
Dec 12, 2023Restorative Botanicals, LLCFood/CosmeticsUnited States
Dec 11, 2023Beckman Coulter, Inc.DevicesUnited States
Dec 8, 2023Gasco Industrial Corp.DrugsUnited States
Dec 8, 2023GFA Production Xiamen Co., Ltd.DrugsChina
Dec 8, 2023Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd.DrugsChina
Dec 8, 2023Micro Labs LimitedDrugsIndia
Dec 7, 2023Vaping StudioTobaccoUnited States
Dec 5, 2023FLVRS US, Inc.TobaccoUnited States
Dec 1, 2023Art Of Beauty Company, IncDrugsUnited States
Dec 1, 2023Barsotti Juice Company, Inc.Food/CosmeticsUnited States
Dec 1, 2023Empower Clinic Services, LLCDrugsUnited States
Dec 1, 2023Porchlight, 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)Develop FSVP29
21 CFR 117.135(a)(1)Sanitation preventive controls - Implement22
21 CFR 820.198(a)Lack of or inadequate complaint procedures20
21 CFR 820.100(a)Lack of or inadequate procedures19
21 CFR 117.35(a)Sanitary operations - Plant sanitation15
21 CFR 117.80(c)Manufacturing, processing, packing, holding - Controls14
21 CFR 211.22(d)Procedures not in writing, fully followed14
21 CFR 1.505(a)(2)Evaluation - performance, risk13
21 CFR 1.506(a)(1)Unapproved supplier procedures - importer established13
21 CFR 117.130(a)(1)Hazard analysis - Identification of hazard11

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 30, 2023Mead Johnson & Company LLCFoodProduct has the potential to be contaminated with Cronobacter sakazakii.
Dec 29, 2023Datex-Ohmeda, Inc.DevicesGE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with…
Dec 29, 2023Datex-Ohmeda, Inc.DevicesGE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with…
Dec 29, 2023Datex-Ohmeda, Inc.DevicesGE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with…
Dec 29, 2023Ocean Group Inc.FoodPotential L. mono contamination as a result of FDA environmental sampling revealing positive findings.
Dec 29, 2023Ocean Group Inc.FoodPotential L. mono contamination as a result of FDA environmental sampling revealing positive findings.
Dec 29, 2023Samsung Bean SproutFoodListeria monocytogenes.
Dec 28, 2023Cardinal Health 200, LLCDevicesCardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject…
Dec 28, 2023Cardinal Health 200, LLCDevicesCardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject…
Dec 28, 2023Cardinal Health 200, LLCDevicesCardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject…
Dec 28, 2023Cardinal Health 200, LLCDevicesCardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject…
Dec 28, 2023Cardinal Health 200, LLCDevicesThe listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with…
Dec 28, 2023Cardinal Health 200, LLCDevicesCardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject…
Dec 28, 2023Cardinal Health 200, LLCDevicesCardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject…
Dec 28, 2023Cardinal Health 200, LLCDevicesThe listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with…
Dec 28, 2023Cardinal Health 200, LLCDevicesCardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject…
Dec 28, 2023Cardinal Health 200, LLCDevicesThe listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with…
Dec 28, 2023Cardinal Health 200, LLCDevicesThe listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with…
Dec 28, 2023Cardinal Health 200, LLCDevicesCardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject…
Dec 28, 2023Cardinal Health 200, LLCDevicesCardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject…
Dec 28, 2023Denver Solutions, LLC DBA Leiters HealthDrugsSuperpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Dec 28, 2023Denver Solutions, LLC DBA Leiters HealthDrugsSuperpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Dec 28, 2023Denver Solutions, LLC DBA Leiters HealthDrugsSuperpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Dec 28, 2023Denver Solutions, LLC DBA Leiters HealthDrugsSuperpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Dec 28, 2023Denver Solutions, LLC DBA Leiters HealthDrugsSuperpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Dec 28, 2023Denver Solutions, LLC DBA Leiters HealthDrugsSuperpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Dec 27, 2023Abiomed, Inc.DevicesIFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to…
Dec 26, 2023Haleon US Holdings LLCDrugsMicrobial Contamination of Non-Sterile Products
Dec 26, 2023Haleon US Holdings LLCDrugsMicrobial Contamination of Non-Sterile Products
Dec 26, 2023Wipro GE Healthcare Private Ltd.DevicesGE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby…
Dec 26, 2023Wipro GE Healthcare Private Ltd.DevicesGE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby…
Dec 26, 2023Wipro GE Healthcare Private Ltd.DevicesGE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby…
Dec 26, 2023Wipro GE Healthcare Private Ltd.DevicesGE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby…
Dec 26, 2023Wipro GE Healthcare Private Ltd.DevicesGE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby…
Dec 26, 2023Wipro GE Healthcare Private Ltd.DevicesGE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby…
Dec 22, 2023Baxter Healthcare CorporationDevicesAn error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of…
Dec 22, 2023Baxter Healthcare CorporationDevicesAn error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of…
Dec 22, 2023Windstone Medical Packaging, Inc.DevicesSterility assurance for saline included in surgical kits cannot be guaranteed.
Dec 22, 2023Windstone Medical Packaging, Inc.DevicesSterility assurance for saline included in surgical kits cannot be guaranteed.
Dec 22, 2023Windstone Medical Packaging, Inc.DevicesSterility assurance for saline included in surgical kits cannot be guaranteed.
Dec 22, 2023Windstone Medical Packaging, Inc.DevicesSterility assurance for saline included in surgical kits cannot be guaranteed.
Dec 22, 2023World Variety Produce Inc Dba Melissa'sFoodUndeclared allergen; fish.
Dec 21, 2023Insight Pharmaceuticals LLC, A Prestige Consumer Healthcare CompanyDrugsChemical Contamination: presence of benzene
Dec 21, 2023PFIZERDrugsPresence of particulate matter: glass
Dec 21, 2023Pfizer Inc.DrugsPresence of Particulate Matter; identified as glass
Dec 21, 2023Pfizer Inc.DrugsPresence of Particulate Matter; identified as glass
Dec 21, 2023Pfizer Inc.DrugsPresence of Particulate Matter; identified as glass
Dec 20, 2023HY SUCCESS INC.FoodContains undeclared sulfites
Dec 20, 2023J T Trading Inc.FoodProduct contains undeclared sulfites.
Dec 20, 2023Samsung Bean SproutFoodThe firm initiated a recall of SoyBean Sprouts because product tested positive for Listeria monocytogenes.
Dec 19, 2023Houdini Inc.FoodPotential Salmonella contamination of Quaker Oats Chewy Granola Bars packed in gift baskets.
Dec 19, 2023Smiths Medical ASD Inc.DevicesMedfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor…
Dec 19, 2023Smiths Medical ASD Inc.DevicesMedfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High…
Dec 18, 2023ROi CPS LLCDevicesSurgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
Dec 15, 2023Chang & Son Enterprises, Inc.FoodProduct contaminated with Listeria monocytogenes.
Dec 15, 2023Eban's Bakehouse LLCFoodUndeclared Allergens - Milk and Soy
Dec 15, 2023Eban's Bakehouse LLCFoodUndeclared Allergens - Milk and Soy
Dec 15, 2023Eban's Bakehouse LLCFoodUndeclared Allergens - Milk and Soy
Dec 15, 2023Eban's Bakehouse LLCFoodUndeclared Allergens - Milk and Soy
Dec 15, 2023Eban's Bakehouse LLCFoodUndeclared Allergens - Milk and Soy
Dec 15, 2023Eban's Bakehouse LLCFoodUndeclared Allergens - Milk and Soy
Dec 15, 2023Eban's Bakehouse LLCFoodUndeclared Allergens - Milk and Soy
Dec 15, 2023Fresh Express IncorpatedFoodThe firm was notified by the Florida Department of Agriculture that the products test positive for Listeria monoctyogenes.
Dec 15, 2023Fresh Express IncorpatedFoodThe firm was notified by the Florida Department of Agriculture that the products test positive for Listeria monoctyogenes.
Dec 15, 2023Philips North AmericaDevicesDetector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for…
Dec 15, 2023Philips North AmericaDevicesDetector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for…
Dec 15, 2023Philips North AmericaDevicesDetector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for…
Dec 15, 2023Publix Super Markets, Inc.FoodThe underlying ingredient, shredded lettuce, was recalled by the supplier Fresh Express due to potential contamination with Listeria…
Dec 15, 2023Publix Super Markets, Inc.FoodThe underlying ingredient, shredded lettuce, was recalled by the supplier Fresh Express due to potential contamination with Listeria…
Dec 15, 2023Publix Super Markets, Inc.FoodThe underlying ingredient, shredded lettuce, was recalled by the supplier Fresh Express due to potential contamination with Listeria…
Dec 15, 2023Publix Super Markets, Inc.FoodThe underlying ingredient, shredded lettuce, was recalled by the supplier Fresh Express due to potential contamination with Listeria…
Dec 15, 2023Publix Super Markets, Inc.FoodThe underlying ingredient, shredded lettuce, was recalled by the supplier Fresh Express due to potential contamination with Listeria…
Dec 15, 2023Publix Super Markets, Inc.FoodThe underlying ingredient, shredded lettuce, was recalled by the supplier Fresh Express due to potential contamination with Listeria…
Dec 13, 2023Maquet Cardiovascular, LLCDevicesExpress chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright…
Dec 13, 2023Maquet Cardiovascular, LLCDevicesExpress chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright…
Dec 12, 2023Percussionaire CorporationDevicesDue to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe…
Dec 8, 2023Megadyne Medical Products, Inc.DevicesAffected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up…
Dec 8, 2023Megadyne Medical Products, Inc.DevicesAffected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up…
Dec 8, 2023Megadyne Medical Products, Inc.DevicesAffected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up…
Dec 8, 2023Megadyne Medical Products, Inc.DevicesAffected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up…
Dec 8, 2023Valley View Candies DbaFoodUndeclared egg
Dec 8, 2023Valley View Candies DbaFoodUndeclared egg
Dec 8, 2023Valley View Candies DbaFoodUndeclared egg
Dec 8, 2023Valley View Candies DbaFoodUndeclared egg
Dec 7, 2023Globus Medical, Inc.DevicesA calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to…
Dec 7, 2023Herold Salads, Inc.FoodPotential contamination with Listeria monocytogenes
Dec 7, 2023Herold Salads, Inc.FoodPotential contamination with Listeria monocytogenes
Dec 7, 2023Herold Salads, Inc.FoodPotential contamination with Listeria monocytogenes
Dec 7, 2023Herold Salads, Inc.FoodPotential contamination with Listeria monocytogenes
Dec 7, 2023Herold Salads, Inc.FoodPotential contamination with Listeria monocytogenes
Dec 7, 2023Herold Salads, Inc.FoodPotential contamination with Listeria monocytogenes
Dec 7, 2023Herold Salads, Inc.FoodPotential contamination with Listeria monocytogenes
Dec 7, 2023Herold Salads, Inc.FoodPotential contamination with Listeria monocytogenes
Dec 7, 2023Herold Salads, Inc.FoodPotential contamination with Listeria monocytogenes
Dec 7, 2023Herold Salads, Inc.FoodPotential contamination with Listeria monocytogenes
Dec 7, 2023Herold Salads, Inc.FoodPotential contamination with Listeria monocytogenes
Dec 7, 2023Herold Salads, Inc.FoodPotential contamination with Listeria monocytogenes
Dec 7, 2023Herold Salads, Inc.FoodPotential contamination with Listeria monocytogenes
Dec 7, 2023Herold Salads, Inc.FoodPotential contamination with Listeria monocytogenes
Dec 7, 2023Herold Salads, Inc.FoodPotential contamination with Listeria monocytogenes

Showing the latest 100 of 136.

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