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FDA Warning Letters, 483s and Recalls: April 2021

FDA enforcement records dated April 2021: 36 warning letters outside tobacco (plus 24 tobacco letters), 25 OAI inspections and 132 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
Apr 30, 2021J & L USA Inc.Division of West Coast ImportsForeign Supplier Verification Program (FSVP)
Apr 29, 2021Africana Market LLCDivision of Northern Border ImportsForeign Supplier Verification Program (FSVP)
Apr 29, 2021Crown Wellness, IncCenter for Food Safety and Applied NutritionNew Drug/Misbranded
Apr 29, 2021Wismettac Asian Foods, Inc.Division of West Coast ImportsForeign Supplier Verification Program (FSVP)
Apr 28, 2021Martinez Produce & Seafood IncOffice of Human and Animal Food Operations East Division VISeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Apr 27, 2021NeuroHydrate LLCOffice of Human and Animal Food Operations East – Division 1New Drug/Misbranded
Apr 27, 2021Professional World StoreCenter for Devices and Radiological HealthPremarket Approval/Misbranded
Apr 26, 2021BMHshopCenter for Devices and Radiological HealthAdulterated and Misbranded Products Related to Coronavirus Disease 2019
Apr 26, 2021C&G Laboratorios SA De CVCenter for Drug Evaluation and ResearchFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Apr 21, 2021DRF LLCOffice of Human and Animal Foods Operations- West DivisionNew Drug/Misbranded
Apr 21, 2021North American Hirudin Biotech Products Inc.Office of Regulatory AffairsNew Drug/Misbranded
Apr 20, 2021Proper Nutrition Inc.Human and Animal Food Division II EastNew Drug/Misbranded
Apr 15, 2021Daisy Global Trading CoDivision of West Coast ImportsForeign Supplier Verification Program (FSVP)
Apr 15, 2021Joe Wise Pharmacy, Inc., Dba Wise PharmacyDivision of Pharmaceutical Quality Operations IVCompounding Pharmacy/Adulterated Drug Products
Apr 15, 2021K & K Distribution, Inc.Division of West Coast ImportsForeign Supplier Verification Program (FSVP)
Apr 15, 2021Molecular BioLife International, Inc.Office of Human and Animal Foods West Division IINew Drug/Misbranded
Apr 15, 2021NEM Advisors LLC / Shop & Save MarketDivision of Northern Border ImportsForeign Supplier Verification Program (FSVP)
Apr 15, 2021Pharmacygeoff.MdCenter for Drug Evaluation and ResearchFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Apr 13, 2021Anytime COVID Test LLCCenter for Devices and Radiological HealthAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Apr 13, 2021Manhattan Stitching Company, Inc.Center for Devices and Radiological HealthAdulterated and Misbranded Products Related to Coronavirus Disease 2019
Apr 13, 2021Orphic NutritionOffice of Human and Animal Food Operations –West Division 5New Drug/Misbranded
Apr 13, 2021Trinity Natural Health & Pain Management, Inc.Center for Drug Evaluation and ResearchUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Apr 12, 2021Hou Fu Biotech - Jiangsu Co., LtdCenter for Drug Evaluation and ResearchFinished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Apr 9, 2021Mr Lukas LLCDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Apr 9, 2021MYM Hidrominerales S.A. De C.V.Center for Drug Evaluation and ResearchFinished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Apr 9, 2021Roque Plast S.A. De C.V.Center for Drug Evaluation and ResearchFinished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Apr 8, 2021Exela Pharma Sciences LLCOffice of Pharmaceutical Quality Operations, Division IIUnapproved New Drug/Compounding/Misbranding
Apr 8, 2021Groupe Cyrenne Inc. Dba HomeoAnimalCenter for Veterinary MedicineUnapproved New Animal Drug Products
Apr 7, 2021About MineralCenter for Drug Evaluation and ResearchUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Apr 7, 2021Allure ImportsCenter for Drug Evaluation and ResearchUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Apr 7, 2021Unived IncOffice of Human and Animal Food Operations- West Division 5New Drug/Misbranded
Apr 6, 2021Sethi LaboratoriesCenter for Devices and Radiological HealthAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Apr 5, 2021American Specialty Pharmacy, Inc. Dba ASP CaresOffice of Pharmaceutical Quality Operations, Division IICompounding Pharmacy/Adulterated Drug Products
Apr 5, 2021Proquimes S A Productos Quimicos Especializados S.A.Center for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Apr 1, 2021Maison Terre, LLCOffice of Pharmaceutical Quality Operations, Division IIDrug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Apr 1, 2021Natural Adventure, LLCCenter for Drug Evaluation and ResearchUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

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
Apr 30, 2021ICU Medical Inc.DevicesUnited States
Apr 29, 2021COLONIAL DAMES CO LTDDrugsUnited States
Apr 28, 2021Akshar Sales LLCFood/CosmeticsUnited States
Apr 26, 2021Sircle Laboratories, L.L.C.DrugsUnited States
Apr 22, 2021Chula Vista Imports LTDFood/CosmeticsUnited States
Apr 22, 2021World Candy Store LlcFood/CosmeticsUnited States
Apr 20, 2021Syngene USA Inc.BiologicsUnited States
Apr 16, 2021Midwestern Pet Foods Inc.VeterinaryUnited States
Apr 15, 2021Abuelito Cheese Inc.Food/CosmeticsUnited States
Apr 15, 2021International General Trading Corp.Food/CosmeticsUnited States
Apr 15, 2021Sunrise Distributors IncFood/CosmeticsUnited States
Apr 14, 2021Tuty USA, LLCFood/CosmeticsUnited States
Apr 13, 2021Evig LLCFood/CosmeticsUnited States
Apr 13, 2021Lopez Gonzalez Santana CorporationFood/CosmeticsUnited States
Apr 12, 2021Age Management Institute Santa BarbaraDrugsUnited States
Apr 12, 2021BMF, Inc.Food/CosmeticsUnited States
Apr 9, 2021Innova Medical Group, Inc.DevicesUnited States
Apr 9, 2021Jaramillo Spices IncFood/CosmeticsUnited States
Apr 8, 2021SevenFood/CosmeticsUnited States
Apr 7, 2021Bravo Packing, Inc.VeterinaryUnited States
Apr 7, 2021Real Water, Inc.Food/CosmeticsUnited States
Apr 7, 2021Real Water, Inc.Food/CosmeticsUnited States
Apr 2, 2021Chameleon Beverage Co IncDrugsUnited States
Apr 2, 2021Fong Kee Tofu Co., Inc.Food/CosmeticsUnited States
Apr 2, 2021Premium Production, 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 FSVP75
21 CFR 117.10Personnel9
21 CFR 1.504(a)Hazard analysis written9
21 CFR 1.505(b)Supplier approval - document9
21 CFR 1.504(b)(1)Hazard analysis biological, chemical, physical8
21 CFR 1.506(a)(1)Approved supplier procedures - importer established8
21 CFR 312.60Informed consent8
21 CFR 117.130(a)(1)Hazard Analysis - Identification of Hazard7
21 CFR 1.506(b)Supplier verification - follow written procedures7
21 CFR 111.103Written procedures - quality control operations6

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
Apr 30, 2021Nutralliance IncFoodIngredient tested positive for milk allergen.
Apr 30, 2021Nutralliance IncFoodIngredient tested positive for milk allergen.
Apr 29, 2021Acella Pharmaceuticals, LLCDrugsSubpotent Drug
Apr 29, 2021Acella Pharmaceuticals, LLCDrugsSubpotent Drug
Apr 29, 2021Acella Pharmaceuticals, LLCDrugsSubpotent Drug
Apr 29, 2021Acella Pharmaceuticals, LLCDrugsSubpotent Drug
Apr 29, 2021Acella Pharmaceuticals, LLCDrugsSubpotent Drug
Apr 27, 2021Quidel CorporationDevicesIn rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct values less than or equal to (d)…
Apr 27, 2021Safeway Fresh Foods LLCFoodSafeway Fresh Foods, 215 N Mill Road, Vineland, New Jersey 08360 is initiating a voluntary recall for Robinson Fresh Turnip Greens, 1 lb…
Apr 27, 2021Scentsational Soaps & Candles IncDrugsChemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Apr 27, 2021Scentsational Soaps & Candles IncDrugsChemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Apr 27, 2021Scentsational Soaps & Candles IncDrugsChemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Apr 27, 2021Scentsational Soaps & Candles IncDrugsChemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Apr 27, 2021Scentsational Soaps & Candles IncDrugsChemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Apr 27, 2021Scentsational Soaps & Candles IncDrugsChemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Apr 27, 2021Scentsational Soaps & Candles IncDrugsChemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Apr 27, 2021Scentsational Soaps & Candles IncDrugsChemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Apr 27, 2021Scentsational Soaps & Candles IncDrugsChemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Apr 27, 2021Scentsational Soaps & Candles IncDrugsChemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Apr 27, 2021Scentsational Soaps & Candles IncDrugsChemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Apr 27, 2021Scentsational Soaps & Candles IncDrugsChemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Apr 27, 2021Scentsational Soaps & Candles IncDrugsChemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Apr 27, 2021Scentsational Soaps & Candles IncDrugsChemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Apr 27, 2021Scentsational Soaps & Candles IncDrugsChemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Apr 27, 2021Scentsational Soaps & Candles IncDrugsChemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Apr 27, 2021Scentsational Soaps & Candles IncDrugsChemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Apr 27, 2021Scentsational Soaps & Candles IncDrugsChemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Apr 27, 2021Scentsational Soaps & Candles IncDrugsChemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Apr 26, 2021Crustaces Baie-Trinite Inc.FoodCooked frozen snow crab sections potentially contaminated with Salmonella and Listeria monocytogenes
Apr 26, 2021LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTDDevicesAntigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution in the U.S.
Apr 26, 2021LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTDDevicesLeccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is not authorized, cleared, or approved for marketing…
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 23, 2021Velvet Ice Cream CompanyFoodPotentially contaminated with Listeria monocytogenes
Apr 22, 2021GOLDEN MEDAL MUSHROOM INCFoodMichigan Department of Agriculture and Rural Development sampled product and results found Listeria monocytogenes.
Apr 21, 2021Basic Grain Products IncFoodUndeclared Milk Allergen
Apr 21, 2021Jule's FoodsFoodProducts have the potential to be contaminated with Salmonella. The cashew cheese is suspect in a current outbreak.
Apr 21, 2021Jule's FoodsFoodProducts have the potential to be contaminated with Salmonella. The cashew cheese is suspect in a current outbreak.
Apr 21, 2021Jule's FoodsFoodProducts have the potential to be contaminated with Salmonella. The cashew cheese is suspect in a current outbreak.
Apr 21, 2021Jule's FoodsFoodProducts have the potential to be contaminated with Salmonella. The cashew cheese is suspect in a current outbreak.
Apr 21, 2021Jule's FoodsFoodProducts have the potential to be contaminated with Salmonella. The cashew cheese is suspect in a current outbreak.
Apr 20, 2021CareFusion 213, LLCDrugsDefective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards…
Apr 20, 2021Forest Mushroom Food Inc.FoodMichigan Department of Agriculture and Rural Development sampled Enoki mushrooms and found some samples to be positive for Listeria…
Apr 16, 2021Creative Foods IncFoodBueno Coffee Substitute Creamy Hazelnut product contains undeclared hazelnut and peanut.
Apr 16, 2021Creative Foods IncFoodBueno Coffee Substitute Pecan Praline Gluten-Free product contains undeclared peanut and barley (which contains gluten).
Apr 14, 2021T MARZETTI INNOVATION CENTERFoodUndeclared Egg Allergen
Apr 12, 2021Boston Scientific CorporationDevicesThe firm has received reports of stent migration after implantation

Showing the latest 100 of 132.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.