Home / Months / January 2020

FDA Warning Letters, 483s and Recalls: January 2020

FDA enforcement records dated January 2020: 0 warning letters outside tobacco, 38 OAI inspections and 61 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
Jan 31, 2020Daito Pharmaceutical Co., Ltd.DrugsJapan
Jan 31, 2020Nassif WholesaleFood/CosmeticsUnited States
Jan 31, 2020ULTRAtab Laboratories, Inc.DrugsUnited States
Jan 30, 2020Angiplast Private LimitedDevicesIndia
Jan 30, 2020Kradjian Importing Company, Inc.Food/CosmeticsUnited States
Jan 30, 2020Laboratorios Dentales De Zona Franca, S.A.DevicesCosta Rica
Jan 24, 2020Pharmaceutical Care SolutionsDrugsUnited States
Jan 23, 2020Custom Nutraceuticals, LLCFood/CosmeticsUnited States
Jan 23, 2020Indus Medicare LimitedDevicesIndia
Jan 23, 2020Nature's Supplements, Inc.Food/CosmeticsUnited States
Jan 23, 2020Sooil Development Co., Ltd.DevicesKorea (the Republic of)
Jan 22, 2020American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc.BiologicsUnited States
Jan 22, 2020Iacofano's Group LLCFood/CosmeticsUnited States
Jan 22, 2020Salud Natural Entrepreneur, Inc.Food/CosmeticsUnited States
Jan 21, 202088 Special Sweet, Inc.Food/CosmeticsUnited States
Jan 21, 2020Cali Rice Valley Inc.Food/CosmeticsUnited States
Jan 21, 2020Montgomery Fertility CenterBiologicsUnited States
Jan 21, 2020Only Natural Inc.Food/CosmeticsUnited States
Jan 17, 2020Actavis Laboratories FL, Inc.DrugsUnited States
Jan 17, 2020Eosera, Inc.DrugsUnited States
Jan 17, 2020Gateway America LLCVeterinaryUnited States
Jan 17, 2020New Tiao Peng Trading, Inc.Food/CosmeticsUnited States
Jan 17, 2020Paisley Farm, LLCFood/CosmeticsUnited States
Jan 17, 2020Quality Dairy CompanyFood/CosmeticsUnited States
Jan 16, 2020Heritage Tobacco LLCTobaccoUnited States
Jan 16, 2020Still Water Dairy, LLCVeterinaryUnited States
Jan 15, 2020Victor Manoharan, DVMVeterinaryUnited States
Jan 10, 2020Fresh & Ready Food GroupFood/CosmeticsUnited States
Jan 10, 2020Grandma's Herbs, Inc.Food/CosmeticsUnited States
Jan 10, 2020Philips Respironics, Inc.DevicesUnited States
Jan 10, 2020ProFresh International Corp.DrugsUnited States
Jan 9, 2020Enzymology Research Center, Inc.Food/CosmeticsUnited States
Jan 9, 2020Maldives Industrial Fisheries Company LimitedFood/CosmeticsMaldives
Jan 9, 2020Post Brands Pet Care, LLCVeterinaryUnited States
Jan 9, 2020Sprouts Unlimited Wholesale Foods IncFood/CosmeticsUnited States
Jan 9, 2020T & S DairyVeterinaryUnited States
Jan 7, 2020Alora Pharmaceuticals LLCDrugsUnited States
Jan 3, 2020Bread And Cie, 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 FSVP34
21 CFR 820.100(a)Lack of or inadequate procedures31
21 CFR 820.198(a)Lack of or inadequate complaint procedures27
21 CFR 117.35(a)Sanitary operations - Plant sanitation23
21 CFR 117.130(a)(1)Hazard Analysis - Identification of Hazard22
21 CFR 117.145(a)Sanitation Controls Monitoring Proced: Establish Implement22
21 CFR 111.70(e)Specifications - identity, purity, strength, composition19
21 CFR 117.35(c)Pest control19
21 CFR 117.80(c)Manufacturing, processing, packing, holding - Controls19
21 CFR 117.37Sanitary facilities and controls17

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
Jan 29, 2020Abbott VascularDevicesCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Jan 29, 2020Abbott VascularDevicesCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Jan 29, 2020Abbott VascularDevicesCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Jan 29, 2020Abbott VascularDevicesCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Jan 29, 2020Abbott VascularDevicesCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Jan 29, 2020Abbott VascularDevicesCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Jan 29, 2020Abbott VascularDevicesCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Jan 29, 2020Abbott VascularDevicesCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Jan 29, 2020Abbott VascularDevicesCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Jan 29, 2020Abbott VascularDevicesCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Jan 29, 2020Abbott VascularDevicesCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Jan 29, 2020Abbott VascularDevicesCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Jan 29, 2020Abbott VascularDevicesCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Jan 29, 2020Abbott VascularDevicesCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Jan 29, 2020Abbott VascularDevicesCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Jan 29, 2020Abbott VascularDevicesCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Jan 29, 2020Abbott VascularDevicesCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Jan 29, 2020Bakkavor Foods USA Inc.FoodThe product contains undeclared milk.
Jan 29, 2020Salud Natural Entrepreneur, Inc.FoodFDA sampling of senna leaves powder, an ingredient used to manufacture the Nopalina Flax Seed Fiber (powder) and Nopalina Flax Seed Fiber…
Jan 29, 2020Salud Natural Entrepreneur, Inc.FoodFDA sampling of senna leaves powder, an ingredient used to manufacture the Nopalina Flax Seed Fiber (powder) and Nopalina Flax Seed Fiber…
Jan 28, 2020Beepas LLCFoodBeepa's Goulash Starter contains undeclared milk.
Jan 28, 2020McCormick & Company, Inc. - Flavor Manufacturing CenterFoodProduct being recalled due to undeclared milk.
Jan 24, 2020Quesos La Ricura, Ltd.FoodPossible contamination with Shiga toxin-producing E. coli (STEC).
Jan 23, 2020Heartware, Inc.DevicesPotential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.
Jan 23, 2020Heartware, Inc.DevicesPotential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.
Jan 15, 2020The Honest StandFoodUndeclared Allergen: Product contains both cashews and almonds, but only almonds were labeled on the physical product. Both allergens were…
Jan 7, 2020CME America, LLCDevicesInfusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster than expected drug delivery when infusing…
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 6, 2020Lipari Foods Operating Company, LLC.FoodProducts recalled due to potential contamination with Listeria monocytogenes
Jan 3, 2020Ducktrap River Of Maine LLCFoodHerring in Wine Sauce contains undeclared milk
Jan 3, 2020Jeni's Splendid Ice Creams LLCFoodMay contain undeclared milk allergen

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.