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FDA Warning Letters, 483s and Recalls: May 2023

FDA enforcement records dated May 2023: 25 warning letters outside tobacco (plus 29 tobacco letters), 38 OAI inspections and 484 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
May 31, 2023Knobbe Cattle Company Inc.Division of Human and Animal Food Operations West IIIllegal Drug Residue Animal Tissue/Adulterated
May 31, 2023Mobeen Mazhar, M.D.Center for Drug Evaluation and Research | CDERInvestigational Device Exemptions (Clinical Investigator)
May 30, 2023Maos ProduceDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
May 26, 2023ImprimisRx NJDivision of Pharmaceutical Quality Operations ICompounding Pharmacy/Adulterated Drug Products
May 26, 2023NeilMed Pharmaceuticals Inc.Division of Pharmaceutical Quality Operations IVCGMP/Finished Pharmaceuticals/Adulterated
May 25, 2023Eco Food Distribution, LLCDivision of Northern Border ImportsForeign Supplier Verification Program (FSVP)
May 25, 2023iRhythm Technologies, Inc.Center for Devices and Radiological HealthMedical Devices/Adulterated/Quality System Regulation (QSR)
May 22, 2023Carolina InfusionDivision of Pharmaceutical Quality Operations IICompounding Pharmacy/Adulterated Drug Products
May 22, 2023Citypharma.UsCenter for Drug Evaluation and Research | CDERUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
May 22, 2023Nutra Blend, LLC Subsidiary Of Land O’LakesDivision of Human and Animal Food Operations West IICGMP/Medicated Feeds/Adulterated
May 19, 2023I.T.S. GmbHCenter for Devices and Radiological HealthCGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated
May 19, 2023Steiner Biotechnology, LLCCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
May 18, 2023Champaklal Maganlal Homeo Pharmacy Private LimitedCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded
May 18, 2023Seafood Brothers Inc., DBA G & L Seafood Inc.Division of West Coast ImportsSeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
May 16, 2023New England Life Care, Inc. Dba Advanced Compounding SolutionsDivision of Pharmaceutical Quality Operations ICompounding Pharmacy/Adulterated Drug Products
May 12, 2023H.E.A.L. MarketplaceDivision of Human and Animal Food Operations East IIINew Drug/Misbranded
May 11, 2023Future Diagnostics Solutions B.V.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
May 11, 2023Manzanola Feeds, LLCDivision of Human and Animal Food Operations West IVCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
May 11, 2023RemedyRepack, Inc.Division of Pharmaceutical Quality Operations ICGMP/Finished Pharmaceuticals/Adulterated
May 10, 2023Rhodes Legacy Inc DBA Sun SproutsDivision of Human and Animal Food Operations West IICGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
May 5, 2023Yichang Jiayuan Foodstuffs Co., LtdCenter for Food Safety and Applied Nutrition (CFSAN)CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
May 3, 2023Bee Healthy Farms LLCDivision of Human and Animal Food Operations West IIInterstate Commerce/Food/Adulterated
May 3, 2023Cosmax NBT USADivision of Human and Animal Food Operations West IIICGMP/Dietary Supplement/Adulterated/Misbranded
May 3, 2023iSlim, LLCDivision of Pharmaceutical Quality Operations IIUnapproved New Drugs/Misbranded
May 1, 2023Drivergent, Inc.Division of Pharmaceutical Quality Operations IIICGMP/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
May 26, 2023Byd Precision Manufacture Co., LtdDevicesChina
May 26, 2023National Chemical LaboratoriesDrugsUnited States
May 24, 2023Wan-Gee Foods IncFood/CosmeticsUnited States
May 23, 2023Euphoria Fancy Food IncFood/CosmeticsUnited States
May 22, 2023Appleton City Feed Service LLCVeterinaryUnited States
May 19, 2023FONA S.R.L.DevicesItaly
May 19, 2023Konrad Rejdak, M.D.BiologicsPoland
May 19, 2023Neitz Instruments Co., Ltd.DevicesJapan
May 19, 2023Rxhomeo Private LimitedDrugsIndia
May 19, 2023Sri Krishna Pharmaceuticals LimitedDrugsIndia
May 18, 2023Agera Tobacco, Inc.TobaccoUnited States
May 18, 2023Global Vitality Inc.Food/CosmeticsUnited States
May 18, 2023Piangwarin Phaosawasdi, M.D.DrugsUnited States
May 18, 2023ReNovo, Inc.DevicesUnited States
May 18, 2023Unisis Corp.DevicesJapan
May 17, 2023TEI Biosciences, Inc.DevicesUnited States
May 16, 2023King Systems Corp.DevicesUnited States
May 16, 2023The Ben Heggy Candy CoFood/CosmeticsUnited States
May 12, 2023American Distribution And Manufacturing Co, LLCVeterinaryUnited States
May 12, 2023Choice Pet Foods IncVeterinaryUnited States
May 12, 2023Glicerinas Industriales, S.A De C.VDrugsMexico
May 11, 2023Lucky K.T. Co., Inc.Food/CosmeticsUnited States
May 11, 2023P.T. Sankei Medical IndustriesDevicesIndonesia
May 10, 2023Continental Manufacturing ChemistDrugsUnited States
May 10, 2023Continental Manufacturing Chemist, Inc.VeterinaryUnited States
May 10, 2023Hemp Berry Kelso, LLCTobaccoUnited States
May 5, 2023Brenntag Great Lakes, LLCDrugsUnited States
May 5, 2023Kor- Chem IncDrugsUnited States
May 4, 2023Caltag Medsystems LtdDevicesUnited Kingdom
May 4, 2023Corporacion Avicola Morovis, Inc.Food/CosmeticsUnited States
May 4, 2023Easy Wholesale, LLCTobaccoUnited States
May 4, 2023Safari Stem Cell, LLCVeterinaryUnited States
May 3, 2023J R Imports LLCFood/CosmeticsUnited States
May 2, 2023Apollo Import Export Inc.Food/CosmeticsUnited States
May 2, 2023EC Supply, Inc.TobaccoUnited States
May 2, 2023Tijuana'S Produce Inc.Food/CosmeticsUnited States
May 1, 2023Charanga Catering, LLCFood/CosmeticsUnited States
May 1, 2023Ikal LLCFood/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 FSVP74
21 CFR 117.35(a)Sanitary operations - Plant sanitation28
21 CFR 1.506(a)(1)Unapproved supplier procedures - importer established26
21 CFR 1.505(a)(2)Evaluation - performance, risk24
21 CFR 1.506(d)(1)(i)Verification activity frequency24
21 CFR 117.130(a)(1)Hazard analysis - Identification of hazard19
21 CFR 117.35(c)Pest control17
21 CFR 117.135(a)(1)Sanitation preventive controls - Implement16
21 CFR 1.506(b)Supplier verification - establish written procedures16
21 CFR 820.198(a)Lack of or inadequate complaint procedures16

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
May 31, 2023The Harvard Drug Group LLC Dba Major Pharmaceuticals And Rugby LaboratoriesDrugsLabeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages…
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella
May 26, 2023Newly Weds Foods, Inc.FoodProducts may contain Salmonella

Showing the latest 100 of 484.

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.