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FDA Warning Letters, 483s and Recalls: October 2023

FDA enforcement records dated October 2023: 23 warning letters outside tobacco (plus 17 tobacco letters), 39 OAI inspections and 122 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
Oct 31, 2023Acrostak Schweiz AGCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Oct 30, 2023Dexterity Health, LLC DBA Zazzee NaturalsCenter for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug
Oct 27, 2023Neurotris, Inc. Dba A1 EngineeringCenter for Devices and Radiological HealthMedical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
Oct 26, 2023Brenntag Great Lakes, LLCDivision of Pharmaceutical Quality Operations IIICGMP/Finished Pharmaceuticals/Adulterated
Oct 24, 2023Abbott LaboratoriesCenter for Biologics Evaluation and Research (CBER)Dietary Supplement/Adulterated
Oct 23, 2023ADM Animal NutritionDivision of Human and Animal Food Operations East VICGMP/Animal Food/Adulterated
Oct 20, 2023Elemental Herbs Inc. D/B/A ALL GoodDivision of Pharmaceutical Quality Operations IVCGMP/Finished Pharmaceuticals/Adulterated
Oct 20, 2023Global Pharma Healthcare Private LimitedCenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated/Misbranded
Oct 20, 2023Maria W. Greenwald, M.D.Center for Drug Evaluation and Research | CDERClinical Investigator
Oct 20, 2023Samm Solutions, Inc., D.B.A. BTS ResearchCenter for Drug Evaluation and Research | CDERGood Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Oct 20, 2023WAVi Co.Division of Medical Device and Radiological Health Operations WestInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Oct 18, 2023Indian Groceries And Spices, Inc.Division of Northern Border ImportsForeign Supplier Verification Program (FSVP)
Oct 18, 2023Natural Relief Inc.Division of Human and Animal Food Operations East VUnapproved New Drugs/Misbranded
Oct 16, 2023Sun Pharmaceutical Industries Ltd.Center for Drug Evaluation and Research | CDERCGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Oct 13, 2023ReNovo, Inc. DBA Provision Device Reprocessing SolutionsCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Oct 12, 2023American Distribution And Manufacturing Co., LLCDivision of Northern Border ImportsForeign Supplier Verification Program (FSVP)
Oct 5, 2023Golden Natural ProductsDivision of Northeast ImportsForeign Supplier Verification Program (FSVP)
Oct 5, 2023Lathem Family Farms, Inc.Division of Human and Animal Food Operations East IIIFood/Egg/Prepared Packed or Held Under Insanitary Conditions/Adulterated
Oct 4, 2023Embryll Life Sciences, Inc.Center for Veterinary MedicineUnapproved New Animal Drug/Adulterated
Oct 4, 2023Handock Cosmetics Co., Ltd.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated/Misbranded/Failure to Register/Unapproved New Drug
Oct 2, 2023Seoul Cosmetics Co., Ltd.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Oct 2, 2023Www.Gorillahealing.ComCenter for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Oct 2, 2023Www.Semaspace.ComCenter for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded

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
Oct 31, 2023Baxter Healthcare CorporationBiologicsUnited States
Oct 27, 2023Bimbo Bakeries USA, Inc.Food/CosmeticsUnited States
Oct 27, 2023FirstCham Co., Ltd.DrugsKorea (the Republic of)
Oct 27, 2023LabAnalysis Life Science S.R.L.DrugsItaly
Oct 27, 2023Regino Produce LLCFood/CosmeticsUnited States
Oct 27, 2023Rise 'N Shine Farm, IncFood/CosmeticsUnited States
Oct 26, 2023Morgan GallacherDrugsUnited States
Oct 26, 2023Philips Healthcare (Suzhou) Co., Ltd.DevicesChina
Oct 25, 2023La Sucursal Produce IncFood/CosmeticsUnited States
Oct 25, 2023Stokes Healthcare Inc.DrugsUnited States
Oct 24, 2023Sen Up Huat Seafood Trading Sdn BhdFood/CosmeticsMalaysia
Oct 24, 2023West Coast Laboratories, Inc.Food/CosmeticsUnited States
Oct 23, 2023Artesanales P.R. LLCDrugsUnited States
Oct 23, 2023Ng Zheng IncFood/CosmeticsUnited States
Oct 23, 2023Products By O2, IncDrugsUnited States
Oct 20, 2023Aqualex Co., Ltd.DrugsKorea (the Republic of)
Oct 20, 2023Jocker's Foods IndustriesFood/CosmeticsPhilippines
Oct 20, 2023Kilitch Healthcare India LimitedDrugsIndia
Oct 20, 2023Nobles Medical Technology, IIDevicesUnited States
Oct 20, 2023SCA Pharmaceuticals, LLCDrugsUnited States
Oct 20, 2023Seatex LLCDrugsUnited States
Oct 20, 2023Top Health Manufacturing, LLCFood/CosmeticsUnited States
Oct 19, 2023Aromas Para El Alma S.A.DrugsCosta Rica
Oct 19, 2023Cloud Hempistry LLCTobaccoUnited States
Oct 19, 2023Vegewax Candleworx Ltd.DrugsCanada
Oct 17, 2023American Cruise Lines Inc.Food/CosmeticsUnited States
Oct 17, 2023Master Paints & Chemical CorpDrugsUnited States
Oct 17, 2023Spartan Enterprises Inc.Food/CosmeticsUnited States
Oct 13, 2023A TRUE MOVE LLCFood/CosmeticsUnited States
Oct 12, 2023DSP Skin Care LLCDrugsUnited States
Oct 12, 2023Panacea Biotec Pharma LimitedDrugsIndia
Oct 11, 2023Potenergy Natural FoodsFood/CosmeticsUnited States
Oct 10, 2023BNG Miracle Pet LLCVeterinaryUnited States
Oct 10, 2023Excite Pharma Services, LLCVeterinaryUnited States
Oct 10, 2023Fresenius Kabi Oncology LimitedDrugsIndia
Oct 6, 2023Apothecus Pharmaceutical Corp.DrugsUnited States
Oct 5, 2023Farmers Union Cooperative, IncVeterinaryUnited States
Oct 3, 2023McClure's Lancaster Old Fashioned, LLCFood/CosmeticsUnited States
Oct 2, 2023Synovo Production, Inc.DevicesUnited 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 FSVP35
21 CFR 211.22(d)Procedures not in writing, fully followed21
21 CFR 211.192Written record of investigation incomplete19
21 CFR 117.10Personnel16
21 CFR 820.100(a)Lack of or inadequate procedures16
21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved15
21 CFR 117.135(a)(1)Sanitation preventive controls - Implement14
21 CFR 117.80(c)Manufacturing, processing, packing, holding - Controls14
21 CFR 117.35(c)Pest control13
FDCA 402(a)(4)Records review prior to shipment for slaughter13

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
Oct 31, 2023Cardinal Health Inc.DrugsNon-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing…
Oct 31, 2023Cardinal Health Inc.DrugsNon-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing…
Oct 31, 2023Cardinal Health Inc.DrugsNon-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing…
Oct 31, 2023Cardinal Health Inc.DrugsNon-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing…
Oct 31, 2023Cardinal Health Inc.DrugsNon-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing…
Oct 31, 2023Cardinal Health Inc.DrugsNon-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing…
Oct 31, 2023The Harvard Drug Group LLC Dba Major Pharmaceuticals And Rugby LaboratoriesDrugsNon-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing…
Oct 31, 2023The Harvard Drug Group LLC Dba Major Pharmaceuticals And Rugby LaboratoriesDrugsNon-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing…
Oct 29, 2023WANABANA USA LLCFoodNorth Carolina Department of Health and Human Services (NCDHHS) sampled product and found it to contain high levels of lead.
Oct 29, 2023WANABANA USA LLCFoodNorth Carolina Department of Health and Human Services (NCDHHS) sampled product and found it to contain high levels of lead.
Oct 29, 2023WANABANA USA LLCFoodNorth Carolina Department of Health and Human Services (NCDHHS) sampled product and found it to contain high levels of lead.
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023Gills Onions, LLCFoodPotential contamination with Salmonella Thompson
Oct 23, 2023The Harvard Drug Group LLC Dba Major Pharmaceuticals And Rugby LaboratoriesDrugsFailed Content Uniformity Specifications
Oct 20, 2023Botanical BeDrugsMarketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Oct 20, 2023Botanical BeDrugsMarketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Oct 20, 2023Botanical BeDrugsMarketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Oct 20, 2023UTOPIA FOODS INCFoodProduct may be contaminated with Listeria monocytogenes.
Oct 19, 2023The Kroger CoFoodPotential contamination of Listeria monocytogenes
Oct 19, 2023Tiffany Food Corp.FoodProducts are a choking hazard
Oct 19, 2023Tiffany Food Corp.FoodProducts are a choking hazard
Oct 19, 2023Tiffany Food Corp.FoodProducts are a choking hazard
Oct 18, 2023Exela Pharma Sciences LLCDrugsPresence of Particulate Matter: Silicone
Oct 18, 2023Exela Pharma Sciences LLCDrugsPresence of Particulate Matter: Silicone
Oct 18, 2023Exela Pharma Sciences LLCDrugsPresence of Particulate Matter: Silicone
Oct 18, 2023VistaPharm LLCDrugsMicrobial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Oct 17, 2023Braga Fresh FoodsFoodUndeclared egg
Oct 17, 2023Safeway Fresh Foods LLCFoodPossible Listeria monocytogenes contamination
Oct 17, 2023Safeway Fresh Foods LLCFoodPossible Listeria monocytogenes contamination

Showing the latest 100 of 122.

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.