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FDA Warning Letters, 483s and Recalls: December 2022

FDA enforcement records dated December 2022: 29 warning letters outside tobacco (plus 9 tobacco letters), 32 OAI inspections and 60 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 29, 2022Salazar & Sons CorpDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Dec 29, 2022Turkuaz Sağlik Hizmetleri Medikal Temizlik KimyasaCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Dec 27, 2022Getsch+Hiller Medizintechnik GmbHCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Dec 27, 2022Globalpharmacyplus.ComUnited StatesUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
Dec 27, 2022North American Diagnostics, LLCCenter for Devices and Radiological HealthMedical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
Dec 27, 2022Urban Electric PowerDivision of Pharmaceutical Quality Operations ICGMP/Drug Products/Adulterated
Dec 21, 2022Salon Technologies International, Inc.Division of Pharmaceutical Quality Operations IICGMP/Finished Pharmaceuticals/Adulterated
Dec 20, 2022Auto-Chlor System LLCDivision of Pharmaceutical Quality Operations IICGMP/Finished Pharmaceuticals/Adulterated
Dec 20, 2022RightEye, LLCDivision of Medical Device and Radiological Health Operations EastInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Dec 20, 2022Ultra Chem Labs CorporationDivision of Pharmaceutical Quality Operations IVCGMP/Finished Pharmaceuticals/Adulterated
Dec 16, 2022Green Pharmaceuticals Inc.Division of Pharmaceutical Quality Operations IVDrug Product/Adulterated
Dec 16, 2022Superior Glove Works, Ltd.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Dec 15, 2022Livestock Nutrition CenterDivision of Human and Animal Food Operations West IIICGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Dec 14, 2022Adarsh Daswani, M.D.Center for Drug Evaluation and Research | CDERClinical Investigator
Dec 13, 2022Optum Infusion Services 308 LLCDivision of Pharmaceutical Quality Operations IVCompounding Pharmacy/Adulterated Drug Products
Dec 13, 2022Quality Supplement Manufacturing, Inc.Division of Pharmaceutical Quality Operations IIICGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Dec 12, 2022Ada TeffDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Dec 12, 2022DELIIMPORTS, LLCDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Dec 12, 2022Olympus Medical Systems CorporationCenter for Devices and Radiological HealthMedical Device Reporting/Misbranded
Dec 12, 2022RDM Express Inc.Division of Human and Animal Food Operations West VSeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Dec 9, 2022Big Olaf Creamery LLC Dba Big OlafDivision of Human and Animal Food Operations East IVCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
Dec 9, 2022Premier Nutra Pharma Inc.Division of Pharmaceutical Quality Operations IVCGMP/Finished Pharmaceuticals/Adulterated
Dec 9, 2022Ruth Special Food Store LLCDivision of Northeast ImportsForeign Supplier Verification Program (FSVP)
Dec 8, 2022Nortec Quimica SACenter for Drug Evaluation and Research | CDERCGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Dec 7, 2022AMO And Wing Inc. Dba T And H Trading Co.Division of West Coast ImportsForeign Supplier Verification Program (FSVP)
Dec 7, 2022Centrient Pharmaceuticals India Private LimitedCenter for Drug Evaluation and Research | CDERCGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Dec 7, 2022San-Rey Produce Inc.Division of Southwest ImportsForeign Supplier Verification Program (FSVP)
Dec 5, 2022Thriftmaster Texas, LLC. D/B/A ThriftMaster Global Holdings, Inc. And TM Global Biosciences, LLCCenter for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated Human Foods
Dec 2, 2022DuPont Nutrition USA Inc.Division of Pharmaceutical Quality Operations ICGMP/Drug Products/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 27, 2022BeiAnn Markets, LLCFood/CosmeticsUnited States
Dec 22, 2022Health SpecialtyDrugsUnited States
Dec 22, 2022M & H Produce IncFood/CosmeticsUnited States
Dec 20, 2022Health Pharma USA LLCDrugsUnited States
Dec 20, 2022Ocho Rios-Miami, Inc.Food/CosmeticsUnited States
Dec 20, 2022Orly International, Inc.DrugsUnited States
Dec 19, 2022Amsino Healthcare (USA) IncDrugsUnited States
Dec 16, 2022Anish S. Shah, M.D.DrugsUnited States
Dec 16, 2022Kevin R. Bender, M.D.DrugsUnited States
Dec 16, 2022Nutra Blend, LLCVeterinaryUnited States
Dec 16, 2022Sentara Infusion ServicesDrugsUnited States
Dec 16, 2022Vinod Maharaj Kava Exports PTE LTDFood/CosmeticsFiji
Dec 15, 2022Capital Imports LLCFood/CosmeticsUnited States
Dec 15, 2022KINGDOM TOBACCO LLCTobaccoUnited States
Dec 15, 2022KOI CBD, LLCFood/CosmeticsUnited States
Dec 15, 2022Melanie M Hoppers, MDDrugsUnited States
Dec 13, 2022KRISHIV FOODSFood/CosmeticsUnited States
Dec 13, 2022Sugar Foods CorporationDrugsUnited States
Dec 13, 2022ZYTO Technologies, Inc.DevicesUnited States
Dec 12, 2022Five Star Trading IL Inc.Food/CosmeticsUnited States
Dec 9, 2022Cooper Institute For Advanced Reproductive MedicineBiologicsUnited States
Dec 9, 2022Dalton Chemical Laboratories Inc.DrugsCanada
Dec 9, 2022Northern VA Compounders PLLCDrugsUnited States
Dec 8, 2022Cloud 9 Systems, LLCTobaccoUnited States
Dec 7, 2022Rosholt Manufacturing, LLCFood/CosmeticsUnited States
Dec 6, 2022AZURE TOBACCO INCTobaccoUnited States
Dec 6, 2022DATELINE KAVAFood/CosmeticsFiji
Dec 2, 2022Intas Pharmaceuticals LimitedDrugsIndia
Dec 2, 2022Liberty Fruit Co IncFood/CosmeticsUnited States
Dec 2, 2022Neilmed Pharmaceuticals IncDrugsUnited States
Dec 1, 2022J & H Imports Services Corp.Food/CosmeticsUnited States
Dec 1, 2022Singing Hawk LLCTobaccoUnited 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 FSVP59
FDCA 501(a)(2)(A)Use of non-pharmaceutical grade components23
21 CFR 117.35(a)Sanitary operations - Plant sanitation18
21 CFR 211.22(d)Procedures not in writing, fully followed16
21 CFR 1.506(d)(1)(i)Verification activity frequency11
21 CFR 312.60Informed consent11
21 CFR 117.135(a)(1)Sanitation preventive controls - Implement10
21 CFR 1.504(b)(1)Hazard analysis biological, chemical, physical10
21 CFR 1.505(a)(2)Evaluation - performance, risk10
21 CFR 211.192Written record of investigation incomplete10

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, 2022Wegmans Food Markets, Inc.FoodProduct contains undeclared wheat.
Dec 28, 2022Kwokcheng Enterprise, Inc. Dba Fullei FreshFoodPossible contamination with Shiga toxin-producing E. coli (non-O157:H7 STEC)
Dec 28, 2022Rhodes Legacy, Inc.FoodAlfalfa sprouts have the potential to be contaminated with Salmonella.
Dec 23, 2022Church Brothers, LLCFoodParsley imported from Mexico was found to be contaminated with Salmonella
Dec 23, 2022FreshPoint South Florida, Inc.FoodParsley imported from Mexico was found to be contaminated with Salmonella
Dec 23, 2022GFA Production Xiamen Co. Ltd.DrugsMicrobial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and…
Dec 23, 2022GFA Production Xiamen Co. Ltd.DrugsMicrobial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and…
Dec 23, 2022GFA Production Xiamen Co. Ltd.DrugsMicrobial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and…
Dec 23, 2022GFA Production Xiamen Co. Ltd.DrugsMicrobial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and…
Dec 23, 2022GFA Production Xiamen Co. Ltd.DrugsMicrobial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and…
Dec 23, 2022GFA Production Xiamen Co. Ltd.DrugsMicrobial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and…
Dec 23, 2022GFA Production Xiamen Co. Ltd.DrugsMicrobial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and…
Dec 23, 2022GFA Production Xiamen Co. Ltd.DrugsMicrobial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and…
Dec 23, 2022GFA Production Xiamen Co. Ltd.DrugsMicrobial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and…
Dec 23, 2022GFA Production Xiamen Co. Ltd.DrugsMicrobial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and…
Dec 22, 2022Getinge Usa Sales IncDevicesDue to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a…
Dec 22, 2022Getinge Usa Sales IncDevicesDue to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a…
Dec 22, 2022Getinge Usa Sales IncDevicesDue to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a…
Dec 22, 2022Pfizer Inc.DrugsPresence of Particulate Matter: Glass particulate matter detected in injectable.
Dec 19, 2022Datascope Corp.DevicesThe Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised…
Dec 19, 2022Datascope Corp.DevicesThe Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised…
Dec 19, 2022GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGDevicesA mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Dec 19, 2022GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGDevicesA mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Dec 19, 2022GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGDevicesA mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Dec 19, 2022GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGDevicesA mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Dec 19, 2022GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGDevicesA mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Dec 19, 2022GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGDevicesA mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Dec 19, 2022Spectrum Laboratory Products, Inc.DrugsDiscoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Dec 19, 2022Spectrum Laboratory Products, Inc.DrugsDiscoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Dec 16, 2022Ventura Foods LlcFoodTartar sauce was found to contain undeclared fish, soy, and milk allergens which was not declared on the label.
Dec 14, 2022Sysco Merchandising And SupplyFoodThe dough ball products contain the undeclared allergen milk.
Dec 14, 2022Sysco Merchandising And SupplyFoodThe dough ball products contain the undeclared allergen milk.
Dec 14, 2022Sysco Merchandising And SupplyFoodThe dough ball products contain the undeclared allergen milk.
Dec 14, 2022Sysco Merchandising And SupplyFoodThe dough ball products contain the undeclared allergen milk.
Dec 14, 2022Sysco Merchandising And SupplyFoodThe dough ball products contain the undeclared allergen milk.
Dec 14, 2022Sysco Merchandising And SupplyFoodThe dough ball products contain the undeclared allergen milk.
Dec 14, 2022Sysco Merchandising And SupplyFoodThe dough ball products contain the undeclared allergen milk.
Dec 14, 2022Sysco Merchandising And SupplyFoodThe dough ball products contain the undeclared allergen milk.
Dec 14, 2022Sysco Merchandising And SupplyFoodThe dough ball products contain the undeclared allergen milk.
Dec 13, 2022UTOPIA FOODS INCFoodProduct may be contaminated with Listeria monocytogenes.
Dec 11, 2022ByHeart, INC.FoodInfant formula potentially contaminated with Cronobacter sakazakii
Dec 9, 2022Smiths Medical ASD Inc.DevicesThere are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing…
Dec 9, 2022Smiths Medical ASD Inc.DevicesThere are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing…
Dec 9, 2022Smiths Medical ASD Inc.DevicesThere are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing…
Dec 9, 2022Smiths Medical ASD Inc.DevicesThere are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing…
Dec 9, 2022Smiths Medical ASD Inc.DevicesThere are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing…
Dec 7, 2022Covidien LPDevicesThere is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may…
Dec 7, 2022Philips Respironics, Inc.DevicesThe replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing…
Dec 7, 2022Philips Respironics, Inc.DevicesThe replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing…
Dec 7, 2022Philips Respironics, Inc.DevicesThe replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing…
Dec 6, 2022Glaxosmithkline Consumer Healthcare Holdings DBA HaleonDrugsLabeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Dec 6, 2022Glaxosmithkline Consumer Healthcare Holdings DBA HaleonDrugsLabeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Dec 6, 2022Glaxosmithkline Consumer Healthcare Holdings DBA HaleonDrugsLabeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Dec 5, 2022Cardiac Assist, IncDevicesA software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The…
Dec 5, 2022Cranberry Sweets & More IncFoodPeanut Butter Meltaway was mis-labeled as Mint Meltaways and peanut is undeclared.
Dec 5, 2022Lidl US TRADINGFoodPotential Salmonella contamination.
Dec 5, 2022Northern Food I/E Inc.FoodProduct contains undeclared sulfites (17.9mg/serving).
Dec 5, 2022THGH Partners, LLCFoodIncorrect product label causing undeclared milk.
Dec 3, 2022Exportadora Copramar Ltda.FoodProduct may be contaminated with Hepatitis A Virus.
Dec 1, 2022BayCare Integrated Service Center, LLC /Dba BayCare Central PharmacyDrugsLabeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL

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.