Home / Months / September 2019

FDA Warning Letters, 483s and Recalls: September 2019

FDA enforcement records dated September 2019: 0 warning letters outside tobacco, 53 OAI inspections and 83 Class I recalls. FDA publishes some records weeks after their date, so recent months can still grow.

· All months ·

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.

No warning letters outside tobacco are recorded for this month yet.

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
Sep 30, 2019Fortune Food Product, Inc.Food/CosmeticsUnited States
Sep 30, 2019Fujifilm CorporationDevicesJapan
Sep 27, 2019Aurobindo Pharma LimitedDrugsIndia
Sep 27, 2019Cipla LimitedDrugsIndia
Sep 27, 2019Fisiopharma SrlDrugsItaly
Sep 26, 2019Fenwal International, Inc.BiologicsUnited States
Sep 26, 2019Mulsen Trading Company LtdFood/CosmeticsUnited States
Sep 26, 2019Swagath Home Foods LLCFood/CosmeticsUnited States
Sep 26, 2019Tropical Bakery Wholesale CorpFood/CosmeticsUnited States
Sep 26, 2019Tuscano And Delucia GroupFood/CosmeticsUnited States
Sep 25, 2019Integrated Health Concepts Inc.DrugsUnited States
Sep 25, 2019Naveed Razzaque, MDDrugsUnited States
Sep 25, 2019R & B Medical Group Inc.BiologicsUnited States
Sep 24, 20198046255 Canada Inc.DrugsCanada
Sep 24, 2019GuiLin SanYang Dietary Ecological Industry Co.Ltd.Food/CosmeticsChina
Sep 24, 2019Novum Pharma, LLCDrugsUnited States
Sep 23, 2019Fujian Guangyang Egg Industry Company LimitedFood/CosmeticsChina
Sep 20, 2019Conformis Inc.DevicesUnited States
Sep 20, 2019Draeger Medical Systems, Inc.DevicesUnited States
Sep 20, 2019ImmuCell CorporationVeterinaryUnited States
Sep 20, 2019Kohyo America, Inc.Food/CosmeticsUnited States
Sep 20, 2019Lupin LimitedDrugsIndia
Sep 20, 2019Royal Iceland HfFood/CosmeticsIceland
Sep 19, 2019AnazaoHealth CorporationDrugsUnited States
Sep 19, 2019Coyote Kitchen, Inc.Food/CosmeticsUnited States
Sep 19, 2019DermaPharm A/SDrugsDenmark
Sep 18, 2019Banco Vida Corp.BiologicsUnited States
Sep 18, 2019Invitrx TherapeuticsBiologicsUnited States
Sep 18, 2019Laboratorio Banco VidaBiologicsUnited States
Sep 17, 2019BEIJING LIUBIJU FOOD CO.,LTD. FOODSTUFFS FACTORYFood/CosmeticsChina
Sep 17, 2019Hangzhou Linkeweier Daily Chemicals Co., Ltd.DrugsChina
Sep 17, 2019TP. Food Canning Ltd., Part.Food/CosmeticsThailand
Sep 13, 2019Apis Vida Industria E Comercio Produtos Farmaceuticos LtdaFood/CosmeticsBrazil
Sep 13, 2019ESSND GLOBALDrugsIndia
Sep 13, 2019NEW WORLD HEALTHCARE PRIVATE LIMITEDDrugsIndia
Sep 13, 2019Tonic Life S De RLFood/CosmeticsMexico
Sep 13, 2019Yusef Manufacturing Laboratories, LLCDrugsUnited States
Sep 12, 2019El Molino Bakery Supplies IncFood/CosmeticsUnited States
Sep 12, 2019FUJIFILM Healthcare Manufacturing Corporation Hitachiomiya OfficeDevicesJapan
Sep 12, 2019Gonzalez And Nietos, LLCFood/CosmeticsUnited States
Sep 12, 2019Innoveix Pharmaceuticals IncDrugsUnited States
Sep 12, 2019Lipari Foods Operating Company LLCFood/CosmeticsUnited States
Sep 11, 2019DAP Pharmaceuticals, LLCDrugsUnited States
Sep 10, 2019FUJIFILM Healthcare Manufacturing Corporation Sano OfficeDevicesJapan
Sep 6, 2019Bulletproof 360 IncFood/CosmeticsUnited States
Sep 6, 2019New 88 Japanese Food Trading IncFood/CosmeticsUnited States
Sep 6, 2019Nowcos Co., Ltd.DrugsKorea (the Republic of)
Sep 6, 2019Pfizer Healthcare India Private LimitedDrugsIndia
Sep 5, 2019CureWave Lasers, LLCDevicesUnited States
Sep 5, 2019Esteve Quimica, S.A.DrugsSpain
Sep 3, 2019Bake Fresh Colorado, LLCFood/CosmeticsUnited States
Sep 3, 2019Klausturbleikja Ehf.Food/CosmeticsIceland
Sep 3, 2019Syntho Pharmaceuticals, Inc.DrugsUnited States

Most-cited Form 483 sections

The CFR sections FDA investigators cited most often in inspections that ended this month.

CFR sectionObservationCitations
21 CFR 123.6(b)No HACCP plan36
21 CFR 123.11(b)Sanitation monitoring documentation31
21 CFR 211.192Written record of investigation incomplete26
21 CFR 820.198(a)Lack of or inadequate complaint procedures24
21 CFR 117.35(a)Sanitary operations - Plant sanitation22
21 CFR 1.502(a)Develop FSVP22
21 CFR 117.35(c)Pest control21
21 CFR 820.100(a)Lack of or inadequate procedures21
21 CFR 117.80(c)Manufacturing, processing, packing, holding - Controls20
21 CFR 117.145(a)Sanitation Controls Monitoring Proced: Establish Implement18

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
Sep 30, 2019Jumbo Foods, Inc.FoodProduct is recalled due to a potential for contamination with Listeria monocytogenes.
Sep 30, 2019Jumbo Foods, Inc.FoodProduct is recalled due to a potential for contamination with Listeria monocytogenes.
Sep 30, 2019Jumbo Foods, Inc.FoodProduct is recalled due to a potential for contamination with Listeria monocytogenes.
Sep 30, 2019Jumbo Foods, Inc.FoodProduct is recalled due to a potential for contamination with Listeria monocytogenes.
Sep 30, 2019Jumbo Foods, Inc.FoodProduct is recalled due to a potential for contamination with Listeria monocytogenes.
Sep 30, 2019Mrs. Stratton's Salads, IncFoodPotential contamination from Listeria monocytogenes.
Sep 30, 2019Northern Tier Bakery LLC Dba SuperMom'sFoodChicken Salad sandwiches have the potential to be contaminated with Listeria monocytogenes.
Sep 30, 2019Whole Foods MarketFoodPotential to contain Listeria monocytogenes
Sep 29, 2019Consider Bardwell Farm, LLCFoodProducts may be contaminated with Listeria monocytogenes
Sep 29, 2019Consider Bardwell Farm, LLCFoodProducts may be contaminated with Listeria monocytogenes
Sep 29, 2019Consider Bardwell Farm, LLCFoodProducts may be contaminated with Listeria monocytogenes
Sep 28, 2019Adm MillingFoodE.coli O26
Sep 28, 2019Adm MillingFoodE.coli O26
Sep 28, 2019Adm MillingFoodE.coli O26
Sep 28, 2019Adm MillingFoodE.coli O26
Sep 28, 2019Adm MillingFoodE.coli O26
Sep 28, 2019Adm MillingFoodE.coli O26
Sep 28, 2019Adm MillingFoodE.coli O26
Sep 28, 2019Adm MillingFoodE.coli O26
Sep 28, 2019Adm MillingFoodE.coli O26
Sep 28, 2019Adm MillingFoodE.coli O26
Sep 28, 2019Adm MillingFoodE.coli O26
Sep 28, 2019Adm MillingFoodE.coli O26
Sep 28, 2019Adm MillingFoodE.coli O26
Sep 28, 2019Adm MillingFoodE.coli O26
Sep 28, 2019Adm MillingFoodE.coli O26
Sep 28, 2019Adm MillingFoodE.coli O26
Sep 28, 2019Adm MillingFoodE.coli O26
Sep 28, 2019Adm MillingFoodE.coli O26
Sep 28, 2019Adm MillingFoodE.coli O26
Sep 27, 2019GE Healthcare, LLCDevicesDisplayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement…
Sep 27, 2019GE Healthcare, LLCDevicesDisplayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement…
Sep 27, 2019GE Healthcare, LLCDevicesDisplayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement…
Sep 27, 2019GE Healthcare, LLCDevicesDisplayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement…
Sep 27, 2019GE Healthcare, LLCDevicesDisplayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement…
Sep 27, 2019GE Healthcare, LLCDevicesDisplayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement…
Sep 27, 2019GE Healthcare, LLCDevicesDisplayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement…
Sep 27, 2019Lyons Magnus, IncFoodProduct mislabeling; undeclared milk. Caramel swirl was mislabeled as mocha swirl
Sep 26, 2019AMPLE HILLS MANUFACTURINGFoodProduct may contain undeclared peanut allergen
Sep 24, 2019Massey Fish CompanyFoodSamples collected by Michigan Department of Agriculture and Rural Development tested positive for Listeria Monocytogenes
Sep 24, 2019Sara Lee Frozen BakeryFoodThe firm was notified from a consumer of foreign material in the product. After examination they discovered that the foreign material was…
Sep 23, 2019California New FoodsFoodFirm received consumer complaint of an allergic reaction after consumption.
Sep 23, 2019California New FoodsFoodFirm received consumer complaint of an allergic reaction after consumption.
Sep 23, 2019California New FoodsFoodFirm received consumer complaint of an allergic reaction after consumption.
Sep 23, 2019California New FoodsFoodFirm received consumer complaint of an allergic reaction after consumption.
Sep 23, 2019California New FoodsFoodFirm received consumer complaint of an allergic reaction after consumption.
Sep 23, 2019California New FoodsFoodFirm received consumer complaint of an allergic reaction after consumption.
Sep 23, 2019California New FoodsFoodFirm received consumer complaint of an allergic reaction after consumption.
Sep 23, 2019California New FoodsFoodFirm received consumer complaint of an allergic reaction after consumption.
Sep 23, 2019California New FoodsFoodFirm received consumer complaint of an allergic reaction after consumption.
Sep 20, 2019Euphoria Fancy Food IncFoodProduct may be contaminated with Listeria monocytogenes.
Sep 20, 2019Roland Foods, LLCFoodPotential to be contaminated with Clostridium botulinum.
Sep 20, 2019Roland Foods, LLCFoodPotential to be contaminated with Clostridium botulinum.
Sep 19, 2019Philips Medical Systems (Cleveland) IncDevicesAn issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to…
Sep 19, 2019Philips Medical Systems (Cleveland) IncDevicesAn issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to…
Sep 19, 2019Philips Medical Systems (Cleveland) IncDevicesAn issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to…
Sep 19, 2019Philips Medical Systems (Cleveland) IncDevicesAn issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to…
Sep 19, 2019Philips Medical Systems (Cleveland) IncDevicesAn issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to…
Sep 17, 2019SOUTHEASTERN GROCERS - MARKETIFood18 count Variety Pack cookies made in-store bakeries included Peanut Butter cookies which were not declared on PDP or ingredient list
Sep 16, 2019CME America, LLCDevicesWhen using a specific tubing set with infusion pump system, may result in under deliver of fluids.
Sep 16, 2019FITOTERAPIA USA, INCDrugsMarketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Sep 16, 2019Schwartz Brothers Restaurants Dba Schwartz Brothers BakeryFoodLemon Dessert Bars product is recalled due to undeclared egg.
Sep 12, 2019Shire Human Genetic Therapies, Inc.DrugsDefective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Sep 12, 2019Shire Human Genetic Therapies, Inc.DrugsDefective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Sep 12, 2019Shire Human Genetic Therapies, Inc.DrugsDefective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Sep 12, 2019Shire Human Genetic Therapies, Inc.DrugsDefective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Sep 12, 2019Veritable VegetableFoodNotified by customer of presumptive positive results for Enterohemorrhagic E. coli (ECHEC)/Shiga Toxin-Producing E. coli (STEC) in fresh…
Sep 11, 2019Lipari Foods Operating Company, LLC.FoodFDA environmental sampling returned a positive test result for Listeria monocytogenes.
Sep 11, 2019Lipari Foods Operating Company, LLC.FoodFDA environmental sampling returned a positive test result for Listeria monocytogenes.
Sep 11, 2019Lipari Foods Operating Company, LLC.FoodFDA environmental sampling returned a positive test result for Listeria monocytogenes.
Sep 11, 2019Lipari Foods Operating Company, LLC.FoodFDA environmental sampling returned a positive test result for Listeria monocytogenes.
Sep 11, 2019Lipari Foods Operating Company, LLC.FoodFDA environmental sampling returned a positive test result for Listeria monocytogenes.
Sep 11, 2019Lipari Foods Operating Company, LLC.FoodFDA environmental sampling returned a positive test result for Listeria monocytogenes.
Sep 11, 2019Rong Shing Trading NY IncFoodProduct may contain undeclared allergens, specifically egg and milk
Sep 11, 2019Rong Shing Trading NY IncFoodProduct may contain undeclared allergens, specifically egg and milk
Sep 11, 2019Urban RemedyFoodRandom sampling of spinach from vendor found Enterohemorrhagic E-Coli/Shiga Toxin Producing E. Coli.
Sep 11, 2019Urban RemedyFoodRandom sampling of spinach from vendor found Enterohemorrhagic E-Coli/Shiga Toxin Producing E. Coli.
Sep 11, 2019Urban RemedyFoodRandom sampling of spinach from vendor found Enterohemorrhagic E-Coli/Shiga Toxin Producing E. Coli.
Sep 11, 2019Urban RemedyFoodRandom sampling of spinach from vendor found Enterohemorrhagic E-Coli/Shiga Toxin Producing E. Coli.
Sep 10, 2019MEDTECH SASDevicesThe instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may…
Sep 9, 2019Hy-VeeFoodundeclared milk in fried rice
Sep 6, 2019Darmerica, LLCDrugsLabel Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.
Sep 3, 2019Euroline Foods LLCFoodDRY FRUIT MIX QUINCE COMPOTE(TAINY VOSTOKA) contains undeclared sulfites

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.