Home / Months / May 2021

FDA Warning Letters, 483s and Recalls: May 2021

FDA enforcement records dated May 2021: 38 warning letters outside tobacco (plus 19 tobacco letters), 34 OAI inspections and 51 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
May 28, 2021Nature’S Distributing; Club Clean Inc/BuyMedicalMasksNow.ComCenter for Devices and Radiological HealthAdulterated and Misbranded Products Related to Coronavirus Disease 2019
May 27, 2021Dongguan City Xinyuan Nonwoven Co., Ltd.Center for Devices and Radiological HealthInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
May 27, 2021Fresh Nutrition IncOffice of Human and Animal Food Operations –West Division 5Unapproved New Drugs/Misbranded
May 27, 2021Incredible Products, SA De CVCenter for Drug Evaluation and ResearchFinished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
May 27, 2021Irvin, Inc.Center for Devices and Radiological HealthAdulterated and Misbranded Products Related to Coronavirus Disease 2019
May 27, 2021OCLO LLC/OCLO Nanotechnology ScienceCenter for Drug Evaluation and ResearchUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
May 26, 2021JLM Nutritionals, Inc. Dba JLM Nutrition—Super Naturals HealthOffice of Human and Animal Food Operations- West Division 5New Drug/Misbranded
May 26, 2021Omega Wonders LLC.Office of Human and Animal Food Operations East Division IVDietary Supplement/New Drug/Misbranded
May 24, 2021Beauty & Spa Concepts, DBA BeenefitsCenter for Food Safety and Applied NutritionUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
May 24, 2021Everything Health LLCCenter for Food Safety and Applied NutritionUnapproved and Misbranded Products Related to Coronavirus Disease 2019(COVID-19)
May 21, 2021Mask Supply StoreCenter for Devices and Radiological HealthInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
May 20, 2021EU Natural Inc.Center for Food Safety and Applied NutritionNew Drug/Misbranded
May 20, 2021Fertility Nutraceuticals LLCCenter for Food Safety and Applied NutritionNew Drug/Misbranded
May 20, 2021LeRoche Benicoeur Dba ConceiveEasyCenter for Food Safety and Applied NutritionNew Drug/Misbranded
May 20, 2021NS Products, Inc.Center for Food Safety and Applied NutritionNew Drug/Misbranded
May 20, 2021Sal Nature LLC/FertilHerbCenter for Food Safety and Applied NutritionNew Drug/Misbranded
May 19, 2021BGP, LLCCenter for Drug Evaluation and ResearchUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
May 19, 2021Smart Women's ChoiceCenter for Drug Evaluation and ResearchFinished Pharmaceuticals/Unapproved New Drug/Misbranded
May 18, 2021Lux Commercial Group LLCDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
May 18, 2021MnM Spices CorporationDivision of Northern Border ImportsForeign Supplier Verification Program (FSVP)
May 18, 2021UmbrellaDivision of Pharmaceutical Quality Operations IVDietary Supplement/Misbranded
May 13, 2021Biotek IndiaCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
May 13, 2021Gulsah Uretim Kozmetik Sanayi Anonim SirketiCenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
May 12, 2021McElroy ImportsDivision of Northeast ImportsForeign Supplier Verification Program (FSVP)
May 11, 2021Kareem Mart Inc.Div ision of Northern Border ImportsForeign Supplier Verification Program (FSVP)
May 11, 2021Utah Cord Bank LLCOffice Biological Products Operations – Division 2Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
May 10, 2021DeChoker LLCOffice of Medical Device and Radiological Health, Division 3CGMP/QSR/Medical Devices/Adulterated
May 10, 2021Great Lakes Gelatin CompanyOffice of Human and Animal Food Operations East-VINew Drug/Misbranded
May 7, 2021Nikkiso Medical America, IncCenter for Devices and Radiological HealthInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
May 7, 2021Selamta LLCDivision of Southeast ImportsForeign Supplier Verification Program (FSVP)
May 6, 2021Covalon Technologies Inc.Center for Drug Evaluation and ResearchUnapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)
May 6, 2021Disinfect & ShieldCenter for Drug Evaluation and ResearchUnapproved Drug Products Related to Coronavirus Disease 2019 (COVID-19)
May 6, 2021Lauren R. Klein, MD, M.S.Center for Drug Evaluation and Research | CDERFailure to obtain Investigational New Drug Applications
May 5, 2021Bio-Botanica, Inc./Nature’S Answer, Inc.Office of Human and Animal Food Operations East – Division 1Dietary Supplement/Adulterated/Cesium Chloride
May 5, 2021Jon B. Cole, MDCenter for Drug Evaluation and Research | CDERFailure to obtain Investigational New Drug Applications
May 4, 2021Baltimore Beauty Security Square MallCenter for Devices and Radiological HealthAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
May 4, 2021Dilip Ceramics Inc. Dba Shivam DistributorsDivision of Southeast ImportsForeign Supplier Verification Program (FSVP)
May 4, 2021Ismar Soluciones Dinámicas S De RL De CVCenter for Drug Evaluation and ResearchFinished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

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
May 28, 2021Bravo Packing, Inc.VeterinaryUnited States
May 28, 2021Prolifix Nutrition, LLCFood/CosmeticsUnited States
May 27, 2021Dibar Nutricional S. De R.L. De C.V.Food/CosmeticsMexico
May 27, 2021Innoveix Pharmaceuticals IncDrugsUnited States
May 26, 2021OCPP LLCVeterinaryUnited States
May 26, 2021Vibrant Enterprise LlcFood/CosmeticsUnited States
May 25, 2021Alma ReserveFood/CosmeticsUnited States
May 25, 2021Miyoshi America, IncDrugsUnited States
May 25, 2021Selected Food & Beverage, Inc.Food/CosmeticsUnited States
May 25, 2021UK Health Security AgencyDrugsUnited Kingdom
May 24, 2021Jule's FoodsFood/CosmeticsUnited States
May 21, 2021Basic Reset Inc.Food/CosmeticsUnited States
May 21, 2021JD's Market Inc.Food/CosmeticsUnited States
May 21, 2021Kim Nhung Marketplace IncFood/CosmeticsUnited States
May 21, 2021Porton Biopharma LimitedDrugsUnited Kingdom
May 21, 2021Salud Natural Entrepreneur, Inc.Food/CosmeticsUnited States
May 19, 2021ITC Global Trading, Inc.Food/CosmeticsUnited States
May 19, 2021Missouri Analytical Laboratories, Inc.DrugsUnited States
May 18, 2021GOLDEN MEDAL MUSHROOM INCFood/CosmeticsUnited States
May 17, 2021Apothecus Pharmaceutical Corp.DrugsUnited States
May 14, 2021Marcus Research Laboratory, Inc.DrugsUnited States
May 14, 2021Pine Pharmaceuticals, LLCDrugsUnited States
May 14, 2021YemenUSA Inc.Food/CosmeticsUnited States
May 13, 2021Ocean Providence Chicago,LLCFood/CosmeticsUnited States
May 12, 2021Western Herb Products IncFood/CosmeticsUnited States
May 11, 2021Mark Roschewski, M.D.DrugsUnited States
May 7, 2021Joseph A. Zadra, MDDrugsCanada
May 6, 2021Ocho Rios-Miami, Inc.Food/CosmeticsUnited States
May 6, 2021Sabra Dipping Company, LLCFood/CosmeticsUnited States
May 5, 2021EBENEZER INTERNATIONAL FOOD LLCFood/CosmeticsUnited States
May 4, 2021Cosmax Nbt Usa, Inc.Food/CosmeticsUnited States
May 4, 2021Dercher Enterprises, Inc.DrugsUnited States
May 3, 2021ALK-Abello, Inc.DrugsUnited States
May 3, 2021Lyden Spice CorporationFood/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 FSVP66
21 CFR 1.505(b)Supplier approval - document8
21 CFR 211.192Written record of investigation incomplete8
21 CFR 111.70(e)Specifications - identity, purity, strength, composition7
21 CFR 1.504(b)(1)Hazard analysis biological, chemical, physical7
21 CFR 1.505(a)(2)Evaluation - performance, risk7
21 CFR 1.506(a)(1)Unapproved supplier procedures - importer established7
21 CFR 1.506(b)Supplier verification - establish written procedures7
21 CFR 111.103Written procedures - quality control operations6
21 CFR 117.35(a)Sanitary operations - Plant sanitation6

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
May 28, 2021CALIFORNIA TERRA GARDEN, INC.FoodSampling by California Department of Public Health found Listeria monocytogenes in Seafood Mushrooms.
May 28, 2021Concord FarmsFoodCalifornia Department of Public Health sampled Concord Farms Enoki Mushrooms which were positive for Listeria monocytogenes.
May 28, 2021Marquis Worldwide Specialty IncFoodCalifornia Department of Public Health sampled Conah Organic Enoki mushrooms with a positive result for Listeria monocytogenes.
May 28, 2021RAINFIELD MARKETING GROUPFoodCalifornia Department of Public Health sampled Enoki mushrooms at retail with a positive result for Listeria monocytogenes.
May 28, 2021Sun Hong Foods, Inc.FoodPotential L. mono contamination due to CDPH product sample findings.
May 27, 2021Tiger NutsFoodProduct may be contaminated with Salmonella.
May 26, 2021HMO Beverage Corp. Dba Organic Gemini LLCFoodProduct may be contaminated with Salmonella.
May 25, 2021Gilster-Mary Lee Corp.FoodButter microwave popcorn bags were packaged in organic salted popcorn consumer boxes and therefore contain undeclared milk
May 24, 2021Giant Eagle, Inc.FoodUndeclared egg allergen
May 24, 2021Hy-Vee Stores IncFoodProduct contains chipotle crema as part of a taco kit which contains undeclared major food allergen egg
May 24, 2021IHERB LLCFoodInformed by contract manufacturer that the MCT ingredient used in their product was under recall due to undeclared milk.
May 22, 2021The Kroger CoFoodUndeclared egg allergen for Chipotle Crema on product label.
May 21, 2021Reser's Fine Foods, Inc.FoodUndeclared egg. The cup of Chipotle Crema in the Chicken Street Taco kits contains undeclared egg.
May 20, 2021Interstate Food Products, LLCFoodProduct samples tested positive for Listeria monocytogenes. The products also contain undeclared soy lecithin.
May 20, 2021Interstate Food Products, LLCFoodProduct samples tested positive for Listeria monocytogenes. The products also contain undeclared soy lecithin.
May 20, 2021Interstate Food Products, LLCFoodProduct samples tested positive for Listeria monocytogenes. The products also contain undeclared soy lecithin.
May 20, 2021Interstate Food Products, LLCFoodProduct samples tested positive for Listeria monocytogenes.
May 19, 2021Vero Biotech, LLCDevicesReports received of NO measured below desired dose during transition between primary console and backup console since Software Version…
May 18, 2021Miracle 8989DrugsMarketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
May 18, 2021Miracle 8989DrugsMarketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
May 18, 2021Miracle 8989DrugsMarketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
May 18, 2021Torn Ranch LLC.FoodRecalling one lot code of Torn Ranch Organic Dark Chocolate Blueberries 18 oz. resealable bags due to a potential for an undeclared…
May 17, 2021Garry N Sun USA Inc.FoodState of Iowa collected consumer sample and found high levels of lead - 12,200 mg/kg
May 17, 2021Natural Foods IncFoodFirm received celery from BCFoods.com and BCFoods.com recalled the celery due to potential safety issue with Salmonella.
May 17, 2021Smiths Medical ASD Inc.DevicesSpecific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings…
May 14, 2021BCFoods, Inc.FoodProduct contains ingredient which tested positive for Salmonella
May 14, 2021BCFoods, Inc.FoodProduct contains ingredient which tested positive for Salmonella
May 14, 2021DeRoyal Industries IncDevicesDeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due…
May 14, 2021DeRoyal Industries IncDevicesDeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due…
May 14, 2021DeRoyal Industries IncDevicesDeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due…
May 13, 2021Organic By Nature, Inc.FoodProduct recalled due to undeclared milk in MCT powder used in manufacturing. Milk is not declared on the label. Product item #'s…
May 12, 2021American Pop Corn CoFoodButtered microwave popcorn bags were packaged inside a regular popcorn box which fails to declare the major food allergen milk.
May 12, 2021Global Sanitizers LLCDrugsChemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be…
May 12, 2021Global Sanitizers LLCDrugsChemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be…
May 11, 2021DIBAR NUTRICIONAL S DE RL DE CVDrugsChemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain…
May 11, 2021People's Custom Rx And Clinical Care, LLCDrugsNon-Sterility
May 11, 2021Yamtun7DrugsMarketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which…
May 7, 2021Magellan Diagnostics, Inc.DevicesMagellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may…
May 7, 2021Magellan Diagnostics, Inc.DevicesMagellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may…
May 7, 2021Magellan Diagnostics, Inc.DevicesMagellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may…
May 7, 2021PRIMARY COLORS DESIGN CORPFoodUndeclared egg allergen on box
May 7, 2021SARA LEE FROZEN FOODSFoodPotentially undeclared peanut
May 7, 2021Slayer Forever, LLC Dba BUBS NaturalsFoodFirm was notified by supplier of Medium Chain Triglycerides (MCT) that it contained undeclared milk allergens.
May 6, 2021Forest Mushroom Food Inc.FoodState of Massachusetts sampled Enoki Mushrooms and found them to be positive for Listeria monocytogenes.
May 5, 2021Arizona Nutritional SupplementsFoodWhey Protein Powder was mistakenly packaged with Soy Protein Powder.
May 5, 2021The Hershey CompanyFoodThe Hershey Company, 19 East Chocolate Avenue, Hershey PA 17033 is voluntarily recalling of a specific lot of Hershey s Chocolate Shell…
May 4, 2021Frito-Lay, Inc. HeadquartersFoodPotential to contain undeclared milk
May 4, 2021Medtronic VascularDevicesThe component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead…
May 4, 2021Simkins Brothers Sweets, LLC Dba Natural Way Food GroupFoodPotential to contain undeclared peanuts
May 3, 2021PFIZER, INCDrugsLabeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection…
May 3, 2021PFIZER, INCDrugsLabeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection…

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.