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FDA Warning Letters, 483s and Recalls: April 2022

FDA enforcement records dated April 2022: 40 warning letters outside tobacco (plus 14 tobacco letters), 53 OAI inspections and 118 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
Apr 28, 2022DLG Naturals, Inc.Office of Human and Animal Food Operations – West Division 1Unapproved New Drugs/Misbranded
Apr 28, 2022Russ Davis Wholesale IncOffice of Human and Animal Food Operations - West Division 1Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Apr 27, 2022Allure Foods LLCDivision of Northeast ImportsForeign Supplier Verification Program (FSVP)
Apr 26, 2022El Dorado Imports IncDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Apr 25, 2022Triple J Fresh, LLCDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Apr 21, 2022Evans Farms FeedDivision of Human and Animal Food Operations West IIICGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Apr 21, 2022MCACO, LTDDivision of Human and Animal Food Operations West IIICGMP/Dietary Supplement/Adulterated
Apr 20, 2022C R Supplements, LLCOffice of Human and Animal Food Operations – West Division 6Unapproved New Drugs/Misbranded
Apr 20, 2022Miami University Department Of Chemistry And BiochemistryPharmaceutical Quality Operations Division IIICGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Apr 20, 2022Thai Union Group PLCCenter for Food Safety and Applied NutritionSeafood HACCP/CGMP for Foods/Adulterated
Apr 19, 2022Fresh Farms LLCDivision of Pharmaceutical Quality Operations IVCGMP/Finished Pharmaceuticals/Adulterated
Apr 19, 2022Guangzhou Zhongkebaishi Health Industry Co., Ltd.Center for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Apr 19, 2022Kleenhanz, LLCCenter for Drug Evaluation and Research | CDERUnapproved Drug Products Related to Coronavirus Disease 2019 (COVID-19)
Apr 18, 2022Age Management Institute Santa BarbaraDivision of Pharmaceutical Quality Operations IVCompounding Pharmacy/Adulterated Drug Products
Apr 18, 2022Fres Co, LLCDivision of Northeast ImportsForeign Supplier Verification Program (FSVP)
Apr 14, 2022Cetylite Industries, Inc.Division of Pharmaceutical Quality Operations ICGMP/Finished Pharmaceuticals/Adulterated
Apr 14, 2022Froggy’S Fog LLCOffice of Pharmaceutical Quality Operations, Division IICGMP/Finished Pharmaceuticals/Adulterated/Misbranded
Apr 14, 2022SCO Koladen LLCWest Coast Import District Compliance Branch - Team 2 (WCID-CB)Foreign Supplier Verification Program (FSVP)
Apr 13, 20227333 LLCDivision of West Coast ImportsForeign Supplier Verification Program (FSVP)
Apr 13, 2022AMBI Enterprises LLCCenter for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Apr 13, 2022Clinical Formula LLCCenter for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Apr 13, 2022Dr. Thomas Balshi/IntilightCenter for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Apr 13, 2022Elements Brands Inc.United StatesFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Apr 13, 2022Genomma Lab USA, Inc.Center for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Apr 13, 2022M & M Beauty And Wellness, LLCCenter for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Apr 13, 2022Neoteric Cosmetics, Incorporated/Scott’S Liquid Gold, Inc.Center for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Apr 13, 2022Skin Authority, L.L.C.Center for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Apr 13, 2022SkinProCenter for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Apr 13, 2022Skin PS BrandsCenter for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Apr 13, 2022True Earth Health Products, LLCCenter for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Apr 13, 2022Ultimark ProductsCenter for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Apr 12, 2022Alymar LLCSouthwest ImportsForeign Supplier Verification Program (FSVP)
Apr 12, 2022The W.S. Badger Company, Inc.Division of Pharmaceutical Quality Operations ICGMP/Finished Pharmaceuticals/Adulterated
Apr 11, 2022Brigham And Women’S Hospital Inc.Office of Pharmaceutical Quality Operations Division ICGMP/Positron Emission Tomography (PET) Drugs/Adulterated
Apr 7, 2022Global Imports Inc.Division of Southwest ImportsForeign Supplier Verification Program (FSVP)
Apr 6, 2022Sensory Cloud, IncCenter for Drug Evaluation and Research | CDERUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Apr 6, 2022Www.Wellerectile.ComCenter for Drug Evaluation and Research | CDERUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
Apr 5, 2022CofixRx, LLCCenter for Drug Evaluation and Research | CDERUnapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)
Apr 5, 2022"Daniel C. Tarquinio, D.O./Center For Rare Neurological DiseasesCenter for Drug Evaluation and Research | CDERClinical Investigator
Apr 1, 2022Las Dos Californias Inc DBA Dulceria Los CuatesDivision 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
Apr 28, 2022CovidienDevicesDominican Republic (the)
Apr 28, 2022EHM Produce, LLC.Food/CosmeticsUnited States
Apr 28, 2022JAS Diagnostics, Inc./Drew Scientific, Inc.DevicesUnited States
Apr 28, 2022Mobeen Mazhar, M.D.DrugsUnited States
Apr 28, 2022New England Life Care, Inc.DrugsUnited States
Apr 27, 2022Adept Life Sciences, LLCFood/CosmeticsUnited States
Apr 27, 2022Advanced Cosmetic Research Laboratories, Inc.DrugsUnited States
Apr 27, 2022Legacy Pharmaceutical Packaging LLCDrugsUnited States
Apr 26, 2022Sai Ram Imports CorporationFood/CosmeticsUnited States
Apr 26, 2022US Specialty Formulations LLCDrugsUnited States
Apr 26, 2022VISVITA CORPORATIONFood/CosmeticsUnited States
Apr 25, 2022Liberty Fruit Co IncFood/CosmeticsUnited States
Apr 25, 2022Positive PromotionsDrugsUnited States
Apr 22, 2022Fairview Mills, LLCVeterinaryUnited States
Apr 22, 2022Petra Hygienic Systems Int LtdDrugsCanada
Apr 22, 2022Sovereign Pharmaceuticals, LLCDrugsUnited States
Apr 22, 2022The Bonami Baking Company, Inc.Food/CosmeticsUnited States
Apr 21, 2022Nemaura Pharma LimitedDevicesUnited Kingdom
Apr 21, 2022Sree Nidhi CorpFood/CosmeticsUnited States
Apr 21, 2022Winfrey's Olde English Fudge Inc.Food/CosmeticsUnited States
Apr 20, 2022David M. Lubeck MDDrugsUnited States
Apr 20, 2022Nephron SC, LLCDrugsUnited States
Apr 20, 2022Nephron SC, LLCDrugsUnited States
Apr 19, 2022Central De AbastoFood/CosmeticsUnited States
Apr 19, 2022Eksa Mills S.A. De C.V.DrugsMexico
Apr 18, 2022The Ben Heggy Candy CoFood/CosmeticsUnited States
Apr 18, 2022TL State Management IncFood/CosmeticsUnited States
Apr 15, 2022Beijing Xinggu Lvsan Technology Co., LtdDrugsChina
Apr 15, 2022Kyowa Hakko Bio Co., Ltd.DrugsJapan
Apr 14, 2022BHARAT RATAN LLCFood/CosmeticsUnited States
Apr 14, 2022EarthLab Holdings IncFood/CosmeticsUnited States
Apr 14, 2022LGM Pharma, LLCDrugsUnited States
Apr 14, 2022LSNE-Madison, LLCVeterinaryUnited States
Apr 14, 2022Perrigo Wisconsin, LLCFood/CosmeticsUnited States
Apr 13, 2022LA SERRANITA IMPORT AND EXPORT LLCFood/CosmeticsUnited States
Apr 13, 2022Med Pen Concepts, LLCDevicesUnited States
Apr 13, 2022Roal Produce Inc.Food/CosmeticsUnited States
Apr 11, 2022Regino Produce LLCFood/CosmeticsUnited States
Apr 11, 2022Sun Sen Co., Inc.Food/CosmeticsUnited States
Apr 8, 2022Bacocas Enterprises Inc.Food/CosmeticsUnited States
Apr 8, 2022LGM Pharma LLCDrugsUnited States
Apr 8, 2022Nature's Rite, LLCFood/CosmeticsUnited States
Apr 8, 2022North30 LLCFood/CosmeticsUnited States
Apr 7, 2022Mexia Pallets LLCFood/CosmeticsUnited States
Apr 7, 2022Naturavit IncFood/CosmeticsUnited States
Apr 7, 2022Raw Bistro, Inc.VeterinaryUnited States
Apr 7, 2022SUPER VAPE'Z LLCTobaccoUnited States
Apr 6, 2022Kwokcheng Enterprise, Inc.Food/CosmeticsUnited States
Apr 6, 2022ROIS Phoenix IncDrugsUnited States
Apr 4, 2022Forcemech International LLCDevicesUnited States
Apr 4, 2022Lupin LimitedDrugsIndia
Apr 4, 2022Somerset Therapeutics Private LimitedDrugsIndia
Apr 1, 2022Lucky's Convenience & Tobacco 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 FSVP55
21 CFR 117.35(a)Sanitary operations - Plant sanitation31
21 CFR 117.35(c)Pest control26
21 CFR 117.10Personnel17
21 CFR 117.130(a)(1)Hazard Analysis - Identification of Hazard16
21 CFR 820.198(a)Lack of or inadequate complaint procedures16
21 CFR 1.506(a)(1)Unapproved supplier procedures - importer established15
21 CFR 1.506(d)(1)(i)Verification activity frequency15
21 CFR 117.40Equipment and utensils - Design and maintenance14
21 CFR 820.100(a)Lack of or inadequate 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
Apr 29, 2022Medtronic Xomed, Inc.DevicesThe firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT…
Apr 29, 2022Medtronic Xomed, Inc.DevicesThe firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT…
Apr 29, 2022Medtronic Xomed, Inc.DevicesThe firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT…
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 28, 2022ELITE CONFECTIONERY LTDFoodPotential contamination with Salmonella
Apr 26, 2022Baxter Healthcare CorporationDevicesThere is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in…
Apr 26, 2022Baxter Healthcare CorporationDevicesThere is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in…
Apr 20, 2022T Fresh Company DBA Yes ProduceFoodCalifornia Department of Public Health sampled product with a result of Listeria monocytogenes
Apr 19, 2022Bakkavor Foods USA Inc.FoodPossible Listeria monocytogenes in product
Apr 19, 2022Damascus Bakery LLCFoodProduct contains undeclared egg allergen.
Apr 19, 2022Doux South Specialties LLCFoodThe firm received a positive test result for Listeria monocytogenes for the product.
Apr 18, 2022GE Healthcare, LLCDevicesInsufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
Apr 18, 2022GE Healthcare, LLCDevicesInsufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
Apr 18, 2022Smiths Medical ASD Inc.DevicesMultiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted…
Apr 18, 2022Smiths Medical ASD Inc.DevicesMultiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted…
Apr 18, 2022World Variety Produce Inc Dba Melissa'sFoodProduct may be contaminated with Salmonella
Apr 15, 2022Valor Compounding Pharmacy, Inc DBA Valor Compounding PharmacyDrugsSubpotent drug
Apr 15, 2022Valor Compounding Pharmacy, Inc DBA Valor Compounding PharmacyDrugsSubpotent drug
Apr 14, 2022Alpine Fresh, Inc.FoodPotential to be contaminated with Listeria monocytogenes. Firm notified FDA of positive result for Hippie Organics- Alpine Fresh French…
Apr 14, 2022Joonsung Trading IncFoodUndeclared soy and wheat. Label declares Mirin but does NOT declare Soy or Wheat.

Showing the latest 100 of 118.

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