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FDA Warning Letters, 483s and Recalls: February 2020

FDA enforcement records dated February 2020: 0 warning letters outside tobacco, 45 OAI inspections and 22 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.

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
Feb 28, 2020Maitland Labs Of Central FloridaDrugsUnited States
Feb 28, 2020Marfish, Inc.Food/CosmeticsUnited States
Feb 28, 2020Nartex Laboratorios Homeopaticos S.A. De C.V.DrugsMexico
Feb 28, 2020Sparhawk Laboratories, Inc.VeterinaryUnited States
Feb 27, 2020D.K.GROCERY INCFood/CosmeticsUnited States
Feb 27, 2020Global Commodities Corp.Food/CosmeticsUnited States
Feb 27, 2020Grand Strand Sandwich Company, Inc.Food/CosmeticsUnited States
Feb 27, 2020Prime Health ProductsFood/CosmeticsCanada
Feb 26, 2020Ace Kava ExportersFood/CosmeticsFiji
Feb 26, 2020Pure Laboratories Manufacturing (Gainesville)TobaccoUnited States
Feb 25, 2020Klarity Medical Products LLCDevicesUnited States
Feb 25, 2020SAS ROQUEFood/CosmeticsFrance
Feb 25, 2020SeaSnax LLCFood/CosmeticsUnited States
Feb 25, 2020Shilpa Medicare LimitedDrugsIndia
Feb 21, 2020ForYou, IncorporatedFood/CosmeticsUnited States
Feb 21, 2020Kalchem International, Inc.DrugsUnited States
Feb 21, 2020Megafine Pharma (P) LimitedDrugsIndia
Feb 20, 2020GBS Commonwealth Co., Ltd.DevicesKorea (the Republic of)
Feb 20, 2020Innovative Intrathecal Solutions, Inc.DrugsUnited States
Feb 20, 2020Mayon's Pharmaceuticals Private LtdDrugsIndia
Feb 20, 2020Panacea Biotec Pharma LimitedDrugsIndia
Feb 19, 2020Express Trading International Inc.Food/CosmeticsUnited States
Feb 19, 2020K D Singh Enterprises LLCFood/CosmeticsUnited States
Feb 19, 2020Somerset Therapeutics Private LimitedDrugsIndia
Feb 14, 2020Galentic Pharma (India) Pvt. LtdDrugsIndia
Feb 14, 2020Luminex CorporationDevicesUnited States
Feb 14, 2020Luminex CorporationDevicesUnited States
Feb 13, 2020Fatima Brothers IncFood/CosmeticsUnited States
Feb 12, 2020Family Pharmacy Of StatesvilleDrugsUnited States
Feb 12, 2020Prime Line Distributors, Inc.Food/CosmeticsUnited States
Feb 11, 2020Promex Distribution LLCFood/CosmeticsUnited States
Feb 10, 2020Atrium Medical CorporationDevicesUnited States
Feb 10, 2020Copley Memorial Hospital IRBDevicesUnited States
Feb 10, 2020Jagger Cone Company, Inc.Food/CosmeticsUnited States
Feb 7, 2020Clientele, Inc.DrugsUnited States
Feb 7, 2020Niagara Pharmaceuticals IncDrugsCanada
Feb 7, 2020Norbrook Laboratories LimitedVeterinaryUnited Kingdom
Feb 7, 2020Norbrook Laboratories LimitedVeterinaryUnited Kingdom
Feb 7, 2020Skin Ecoguard S.A. De C.V.DrugsMexico
Feb 7, 2020Tailor Cut Produce Inc.Food/CosmeticsUnited States
Feb 6, 2020Abuelito Cheese Inc.Food/CosmeticsUnited States
Feb 6, 2020Primus CorporationDevicesUnited States
Feb 5, 2020David Rosen Bakery Supplies Company, Inc.Food/CosmeticsUnited States
Feb 4, 2020Carey USA LLCFood/CosmeticsUnited States
Feb 3, 2020Ideal Implant IncorporatedDevicesUnited 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 FSVP49
21 CFR 820.198(a)Lack of or inadequate complaint procedures28
21 CFR 820.100(a)Lack of or inadequate procedures23
21 CFR 117.35(a)Sanitary operations - Plant sanitation21
21 CFR 211.192Written record of investigation incomplete18
21 CFR 117.80(c)Process Control Measures16
21 CFR 117.145(a)Sanitation Controls Monitoring Proced: Establish Implement15
21 CFR 123.11(b)Sanitation monitoring documentation15
21 CFR 117.130(a)(1)Hazard Analysis - Identification of Hazard14
21 CFR 117.35(c)Pest control14

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
Feb 26, 2020Choice Products LLC.FoodPeanut Butter Cookie Dough may contain undeclared milk.
Feb 24, 2020Shearer'S SnacksFoodProduct may contain undeclared milk.
Feb 21, 2020Moonstruck Chocolate CompanyFoodUndeclared milk.
Feb 18, 2020Saratoga Potato Chips LLCFoodUndeclared milk
Feb 14, 2020Micro Therapeutics Inc, Dba Ev3 NeurovascularDevicesEmbolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended…
Feb 14, 2020Micro Therapeutics Inc, Dba Ev3 NeurovascularDevicesEmbolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended…
Feb 11, 2020Boston Scientific CorporationDevicesPotential for tip detachment of Imager II 5F Angiographic Catheters
Feb 10, 2020Blendtopia Products, LLCFoodPotential contamination of Listeria monocytogenes.
Feb 10, 2020Blendtopia Products, LLCFoodPotential contamination of Listeria monocytogenes.
Feb 10, 2020Blendtopia Products, LLCFoodPotential contamination of Listeria monocytogenes.
Feb 10, 2020Blendtopia Products, LLCFoodPotential contamination of Listeria monocytogenes.
Feb 10, 2020Blendtopia Products, LLCFoodPotential contamination of Listeria monocytogenes.
Feb 7, 2020PNW Veg Co LLCFoodFLAV-R-PAC Roasted Spicy Potatoes Obrien was recalled due to undeclared wheat and soy.
Feb 7, 2020Taro Pharmaceuticals U.S.A., Inc.DrugsResuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy…
Feb 4, 2020CareFusion 303, Inc.Devices1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption…
Feb 4, 2020CareFusion 303, Inc.Devices1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption…
Feb 4, 2020CareFusion 303, Inc.Devices1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption…
Feb 4, 2020CareFusion 303, Inc.Devices1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption…
Feb 4, 2020Whole Foods MarketFoodUndeclared milk
Feb 4, 2020Whole Foods MarketFoodUndeclared milk
Feb 4, 2020Whole Foods MarketFoodUndeclared milk
Feb 4, 2020Whole Foods MarketFoodUndeclared milk

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.