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FDA Warning Letters, 483s and Recalls: May 2022

FDA enforcement records dated May 2022: 49 warning letters outside tobacco (plus 15 tobacco letters), 40 OAI inspections and 161 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 31, 2022Dara Food LLCDivision of Northeast ImportsForeign Supplier Verification Program (FSVP)
May 31, 2022Daxa Foods, Inc. Dba India GrocersDivision of Northeast ImportsForeign Supplier Verification Program (FSVP)
May 31, 2022Export Guatemala CorporationDivision of Southeast ImportsForeign Supplier Verification Program (FSVP)
May 27, 2022Re-Gen Active Lab, Inc.Office of Biological Products Operations – Division 2Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
May 27, 2022Smitha C. Reddy, M.D./ACRC Studies, LLCCenter for Drug Evaluation and Research | CDERClinical Investigator
May 26, 2022Everyday Import & Export, Inc. Dba Everyday Group LLCDivision of Northeast ImportsForeign Supplier Verification Program (FSVP)
May 26, 2022Golden Lab LLCOffice of Human and Animal Food Operations East Division IVUnapproved New Drugs/Misbranded
May 26, 2022Haniel Concepts, Inc. DBA Free State Oils, LLCCenter for Veterinary MedicineUnapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
May 26, 2022Hope Botanicals, LLCCenter for Veterinary MedicineUnapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
May 26, 2022Plantacea, LLC Dba KahmCenter for Veterinary MedicineUnapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
May 24, 2022Jap Inc. Dba Intercontinental FoodsDivision of Northern Border ImportsForeign Supplier Verification Program (FSVP)
May 23, 2022Aire-Master Of America, Inc.Division of Pharmaceutical Quality Operations IIICGMP/Finished Pharmaceuticals/Adulterated
May 23, 2022Grimann S.A. De C.V.Center for Drug Evaluation and Research | CDERFailure to Comply with Drug Registration and Listing Requirements
May 19, 2022Ayuryoga, Inc.Center for Drug Evaluation and Research | CDERUnapproved New Drug
May 19, 2022Santhigram Kerala Ayurvedic Co. Of U.S., Inc.Center for Drug Evaluation and Research | CDERUnapproved New Drugs
May 18, 2022New Vitalis, LLC Dba New Vitalis PharmacyDivision of Pharmaceutical Quality Operations IIICompounding Pharmacy/Adulterated Drug Products
May 17, 2022Valley View Milling LLCOffice of Human and Animal Food- West Division IICGMP/Medicated Feeds/Adulterated
May 16, 2022Equine Podiatry Solutions, LLCCenter for Veterinary MedicineUnapproved New Animal Drug Products
May 13, 2022Krishna Trading LLCDivision of Northern Border ImportsForeign Supplier Verification Program (FSVP)
May 12, 2022Genlabs CorporationDivision of Pharmaceutical Quality Operations IVCGMP/Finished Pharmaceuticals/Adulterated
May 12, 2022La Ilusion Fresh Guava Inc.Division of Northern Border ImportsForeign Supplier Verification Program (FSVP)
May 11, 2022Coastal Fresh Farms, Inc.Division of West Coast ImportsForeign Supplier Verification Program (FSVP)
May 10, 2022Colorful Products CorporationDivision of Pharmaceutical Quality Operations IVCGMP/Finished Pharmaceuticals/Adulterated
May 10, 2022Greenfield Produce ImportsDivision of West Coast ImportsForeign Supplier Verification Program (FSVP)
May 9, 2022Yakamoz Sirke Ferm Urunleri Gida Tas San Ve Tic Ltd STICenter for Food Safety and Applied Nutrition (CFSAN)Juice/HACCP/Adulterated
May 9, 2022Zhoushan Haichang Co. LtdCenter for Food Safety and Applied Nutrition (CFSAN)Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
May 5, 2022Yippee Farms, LLCDivision of Human and Animal Food Operations East IIIllegal Drug Residue Animal Tissue/Adulterated
May 4, 2022Advanced Nutritional Supplements LLCCenter for Food Safety and Applied Nutrition (CFSAN)Dietary Supplement/Adulterated
May 4, 2022Assault LabsCenter for Food Safety and Applied Nutrition (CFSAN)Dietary Supplement/Adulterated
May 4, 2022ATLRx, Inc.Center for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
May 4, 2022BioMD Plus LLCCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
May 4, 2022Complete NutritionCenter for Food Safety and Applied Nutrition (CFSAN)Dietary Supplement/Adulterated
May 4, 2022Delta 8 HempCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
May 4, 2022Exclusive Nutrition Products, LLCCenter for Food Safety and Applied Nutrition (CFSAN)Dietary Supplement/Adulterated
May 4, 2022Fresh Imports International LLCDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
May 4, 2022Hainan Golden Spring Foods Co. Ltd.Center for Food Safety and Applied Nutrition (CFSAN)Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
May 4, 2022Inhousepharmacy.VuCenter for Drug Evaluation and Research | CDERNotice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet
May 4, 2022Ironmag LabsCenter for Food Safety and Applied Nutrition (CFSAN)Dietary Supplement/Adulterated
May 4, 2022Kingdom HarvestCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
May 4, 2022Max MuscleCenter for Food Safety and Applied Nutrition (CFSAN)Dietary Supplement/Adulterated
May 4, 2022M Six Labs, Inc.Center for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
May 4, 2022New York Nutrition CompanyCenter for Food Safety and Applied Nutrition (CFSAN)Dietary Supplement/Adulterated
May 4, 2022Nutritional Sales And Customer Service, LLCCenter for Food Safety and Applied Nutrition (CFSAN)Dietary Supplement/Adulterated
May 4, 2022Performax Labs IncCenter for Food Safety and Applied Nutrition (CFSAN)Dietary Supplement/Adulterated
May 4, 2022Steel Supplements IncCenter for Food Safety and Applied Nutrition (CFSAN)Dietary Supplement/Adulterated
May 3, 2022Specialty Process Labs LLCDivision of Pharmaceutical Quality Operations IVCGMP/Active Pharmaceutical Ingredient (API)/Adulterated
May 2, 2022A.N.N. Imports LLCDivision of West Coast ImportsForeign Supplier Verification Program (FSVP)
May 2, 2022David Cosmetic Co., Ltd.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceutical/Adulterated
May 2, 2022Subhlaxmi GrocersDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)

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 31, 2022Florida Gold Foods LLCFood/CosmeticsUnited States
May 27, 2022Degasa S.A. De C.V.DrugsMexico
May 27, 2022Gold Coast Distributors, Inc.Food/CosmeticsUnited States
May 27, 2022Kobayashi America Manufacturing, LLCDrugsUnited States
May 27, 2022Premium Production, LLCFood/CosmeticsUnited States
May 27, 2022Steven C. Kester, M.D.DrugsUnited States
May 26, 2022Evig LLCFood/CosmeticsUnited States
May 26, 2022MicroVention Costa Rica S.R.L.DevicesCosta Rica
May 25, 2022Brew City Juice LLCTobaccoUnited States
May 25, 2022K2 Trading Inc.Food/CosmeticsUnited States
May 25, 2022Midwestern Pet Foods Inc.VeterinaryUnited States
May 25, 2022Myllan-ORA EhfFood/CosmeticsIceland
May 24, 2022Rich River Produce, LLCFood/CosmeticsUnited States
May 24, 2022The See Clear CompanyDevicesUnited States
May 21, 2022Cantoro Food MarketFood/CosmeticsUnited States
May 20, 2022Certified Laboratories LLCDrugsUnited States
May 20, 2022Clive Ballard, M.D.DrugsUnited Kingdom
May 20, 2022Glenmark Pharmaceuticals LimitedDrugsIndia
May 20, 2022Jeanette & Kristine Enterprise Inc.Food/CosmeticsUnited States
May 20, 2022Minuti Coffee LLCFood/CosmeticsUnited States
May 19, 2022Abbott Point Of Care Canada LimitedDevicesCanada
May 19, 2022Devon Orthopaedic Implants LLC.,DevicesUnited States
May 19, 2022Glenmark Pharmaceuticals Inc USADrugsUnited States
May 17, 2022Akorn Operating Company LLCVeterinaryUnited States
May 16, 2022HH & CN Investment CorpFood/CosmeticsUnited States
May 16, 2022Skyless LLCDrugsUnited States
May 13, 2022RELIANCE SERVICEFood/CosmeticsUnited States
May 12, 2022Nachman's Native Seafood, Inc.Food/CosmeticsUnited States
May 11, 2022Frontier Ag, Inc.VeterinaryUnited States
May 10, 2022Mina Global Trading CorpFood/CosmeticsUnited States
May 10, 2022Safe Chain Solutions, LlcDrugsUnited States
May 10, 2022Smokalo, Inc.TobaccoUnited States
May 10, 2022USA Vapor TrailsTobaccoUnited States
May 9, 2022MD Pharmaceutical Supply, LLCDrugsUnited States
May 9, 2022Sun Pharmaceutical Industries Ltd.DrugsIndia
May 6, 2022AX Pharmaceutical CorporationDrugsCanada
May 6, 2022Omega & Delta Co., Inc.DrugsUnited States
May 6, 2022Paris Brothers, Inc.Food/CosmeticsUnited States
May 5, 2022C. Liberatore LLCFood/CosmeticsUnited States
May 4, 2022CUGINI DISTRUBUTION 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 FSVP61
21 CFR 117.35(a)Sanitary operations - Plant sanitation28
21 CFR 117.35(c)Pest control20
21 CFR 1.506(b)Supplier verification - follow written procedures19
21 CFR 117.80(c)Manufacturing, processing, packing, holding - Controls17
21 CFR 1.505(a)(2)Evaluation - performance, risk15
21 CFR 1.506(a)(1)Unapproved supplier procedures - importer established15
21 CFR 117.10Personnel14
21 CFR 1.504(a)Hazard analysis written13
21 CFR 1.506(d)(1)(i)Verification activity frequency13

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 27, 2022Taylor Farms Retail IncFoodIncorrect salad kit causing undeclared allergens (egg and wheat).
May 26, 2022Albanese Confectionery Group, Inc.FoodSalmonella. Product made using recalled Jif peanut butter
May 26, 2022Amazon.Com, Inc.DrugsMarketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
May 26, 2022Amazon.Com, Inc.DrugsMarketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
May 26, 2022Amazon.Com, Inc.DrugsMarketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
May 24, 2022Bix Produce Company LLCFoodPotential Salmonella contamination.
May 24, 2022Calico Cottage IncFoodFudge contains peanut butter that is potentially contaminated with Salmonella.
May 24, 2022Calico Cottage IncFoodFudge contains peanut butter that is potentially contaminated with Salmonella.
May 24, 2022Calico Cottage IncFoodFudge contains peanut butter that is potentially contaminated with Salmonella.
May 24, 2022Calico Cottage IncFoodFudge contains peanut butter that is potentially contaminated with Salmonella.
May 24, 2022Del Monte Fresh Produce CompanyFoodThe peanut butter in the snack items have the potential to be contaminated with Salmonella.
May 24, 2022Del Monte Fresh Produce CompanyFoodThe peanut butter in the snack items have the potential to be contaminated with Salmonella.
May 24, 2022Del Monte Fresh Produce CompanyFoodThe peanut butter in the snack items have the potential to be contaminated with Salmonella.
May 24, 2022Del Monte Fresh Produce CompanyFoodThe peanut butter in the snack items have the potential to be contaminated with Salmonella.
May 24, 2022Euphoria Trading Company, LLC.FoodPotential contamination with Salmonella. Product contains Jif peanut butter.
May 24, 2022Euphoria Trading Company, LLC.FoodPotential contamination with Salmonella. Product contains Jif peanut butter.
May 24, 2022Euphoria Trading Company, LLC.FoodPotential contamination with Salmonella. Product contains Jif peanut butter.
May 24, 2022Fudgeamentals LLCFoodmade with peanut butter contaminated with Salmonella
May 24, 2022Fudgeamentals LLCFoodmade with peanut butter contaminated with Salmonella
May 24, 2022Fudgeamentals LLCFoodmade with peanut butter contaminated with Salmonella
May 24, 2022Fudgeamentals LLCFoodmade with peanut butter contaminated with Salmonella
May 24, 2022Fudgeamentals LLCFoodmade with peanut butter contaminated with Salmonella
May 24, 2022Fudgeamentals LLCFoodmade with peanut butter contaminated with Salmonella
May 24, 2022Fudgeamentals LLCFoodmade with peanut butter contaminated with Salmonella
May 24, 2022Walmart IncDrugsMarketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal…
May 23, 2022A G Specialty Foods IncFoodPotential contamination with Salmonella.
May 23, 2022A G Specialty Foods IncFoodPotential contamination with Salmonella.
May 23, 2022A G Specialty Foods IncFoodPotential contamination with Salmonella.
May 23, 2022A G Specialty Foods IncFoodPotential contamination with Salmonella.
May 23, 2022Akcea Therapeutics, Inc.DrugsSuperpotent: High Out of specification (OOS) test result for percent label claim (%LC).
May 23, 2022Cargill Cocoa And Chocolate IncFoodPossible contamination with Salmonella
May 23, 2022Cargill Cocoa And Chocolate IncFoodPossible contamination with Salmonella
May 23, 2022Cargill Cocoa And Chocolate IncFoodPossible contamination with Salmonella
May 23, 2022Cargill Cocoa And Chocolate IncFoodPossible contamination with Salmonella
May 23, 2022Cargill Cocoa And Chocolate IncFoodPossible contamination with Salmonella
May 23, 2022Cargill Cocoa And Chocolate IncFoodPossible contamination with Salmonella
May 23, 2022Cargill Cocoa And Chocolate IncFoodPossible contamination with Salmonella
May 23, 2022F&S Produce Co., Inc.FoodProduct was made with peanut butter contaminated with Salmonella.
May 23, 2022Giant EagleFoodProducts were made with Jiff Peanut Butter and have the potential for Salmonella Contamination.
May 23, 2022Giant EagleFoodProducts were made with Jiff Peanut Butter and have the potential for Salmonella Contamination.
May 23, 2022Giant EagleFoodProducts were made with Jiff Peanut Butter and have the potential for Salmonella Contamination.
May 23, 2022Giant EagleFoodProducts were made with Jiff Peanut Butter and have the potential for Salmonella Contamination.
May 23, 2022Giant EagleFoodProducts were made with Jiff Peanut Butter and have the potential for Salmonella Contamination.
May 23, 2022Giant EagleFoodProducts were made with Jiff Peanut Butter and have the potential for Salmonella Contamination.
May 23, 2022Giant EagleFoodProducts were made with Jiff Peanut Butter and have the potential for Salmonella Contamination.
May 23, 2022Giant EagleFoodProducts were made with Jiff Peanut Butter and have the potential for Salmonella Contamination.
May 23, 2022Giant EagleFoodProducts were made with Jiff Peanut Butter and have the potential for Salmonella Contamination.
May 23, 2022Giant EagleFoodProducts were made with Jiff Peanut Butter and have the potential for Salmonella Contamination.
May 23, 2022Giant EagleFoodProducts were made with Jiff Peanut Butter and have the potential for Salmonella Contamination.
May 23, 2022Indianapolis Fruit Company, Inc.FoodProducts contain peanut butter that may be contaminated with Salmonella.
May 23, 2022Indianapolis Fruit Company, Inc.FoodProducts contain peanut butter that may be contaminated with Salmonella.
May 23, 2022Indianapolis Fruit Company, Inc.FoodProducts contain peanut butter that may be contaminated with Salmonella.
May 23, 2022Klein Foods, IncFoodpotential Salmonella contamination
May 23, 2022Mary's Harvest Fresh Foods, Inc.FoodPotential contamination with Salmonella.
May 23, 2022Mary's Harvest Fresh Foods, Inc.FoodPotential contamination with Salmonella.
May 23, 2022Safeway Fresh Foods LLCFoodProduct was made with peanut butter that is potentially contaminated with Salmonella.
May 23, 2022TAHARKA BROTHER'S ICE CREAMFoodMay be contaminated with Salmonella
May 23, 2022Taher, Inc.FoodProduct contains .75 oz container of Jif Peanut Butter that is recalled due to Salmonella contamination.
May 23, 2022Taylor Farms New Jersey, Inc.FoodPossible contamination with Salmonella
May 23, 2022Walnut Creek Chocolate Co IncFoodPotential Salmonella contamination
May 23, 2022Walnut Creek Chocolate Co IncFoodPotential Salmonella contamination
May 23, 2022Walnut Creek Chocolate Co IncFoodPotential Salmonella contamination
May 23, 2022Walnut Creek Chocolate Co IncFoodPotential Salmonella contamination
May 23, 2022Walnut Creek Chocolate Co IncFoodPotential Salmonella contamination
May 23, 2022Walnut Creek Chocolate Co IncFoodPotential Salmonella contamination
May 23, 2022Walnut Creek Chocolate Co IncFoodPotential Salmonella contamination
May 23, 2022Walnut Creek Chocolate Co IncFoodPotential Salmonella contamination
May 23, 2022Walnut Creek Chocolate Co IncFoodPotential Salmonella contamination
May 23, 2022Walnut Creek Chocolate Co IncFoodPotential Salmonella contamination
May 23, 2022Walnut Creek Chocolate Co IncFoodPotential Salmonella contamination
May 23, 2022Walnut Creek Chocolate Co IncFoodPotential Salmonella contamination
May 23, 2022Walnut Creek Chocolate Co IncFoodPotential Salmonella contamination
May 23, 2022Walnut Creek Chocolate Co IncFoodPotential Salmonella contamination
May 23, 2022Walnut Creek Chocolate Co IncFoodPotential Salmonella contamination
May 22, 2022Deskins Wholesale, LLCFoodProducts were made with peanut butter contaminated with Salmonella.
May 22, 2022Deskins Wholesale, LLCFoodProducts were made with peanut butter contaminated with Salmonella.
May 22, 2022Deskins Wholesale, LLCFoodProducts were made with peanut butter contaminated with Salmonella.
May 22, 2022Deskins Wholesale, LLCFoodProducts were made with peanut butter contaminated with Salmonella.
May 22, 2022Desserts By Helen, Inc.FoodProduct contained JIF peanut butter and was manufactured during the JIF recall time period in 2022. Product was recalled out of an…
May 22, 2022General Mills James Ford Bell Technical CenterFoodPotential Salmonella contamination.
May 22, 2022Stellex/CF Houston, LLCFoodPotential to be contaminated with Salmonella
May 22, 2022Stellex/CF Houston, LLCFoodPotential to be contaminated with Salmonella
May 22, 2022Stellex/CF Houston, LLCFoodPotential to be contaminated with Salmonella
May 22, 2022Stellex/CF Houston, LLCFoodPotential to be contaminated with Salmonella
May 22, 2022Stellex/CF Houston, LLCFoodPotential to be contaminated with Salmonella
May 21, 2022Albertsons Companies LLCFoodPotential Salmonella contamination.
May 21, 2022Albertsons Companies LLCFoodPotential Salmonella contamination.
May 21, 2022Albertsons Companies LLCFoodPotential Salmonella contamination.
May 21, 2022Albertsons Companies LLCFoodPotential Salmonella contamination.
May 21, 2022Albertsons Companies LLCFoodPotential Salmonella contamination.
May 21, 2022Albertsons Companies LLCFoodPotential Salmonella contamination.
May 21, 2022Albertsons Companies LLCFoodPotential Salmonella contamination.
May 21, 2022Albertsons Companies LLCFoodPotential Salmonella contamination.
May 21, 2022Albertsons Companies LLCFoodPotential Salmonella contamination.
May 21, 2022Albertsons Companies LLCFoodPotential Salmonella contamination.
May 21, 2022Albertsons Companies LLCFoodPotential Salmonella contamination.
May 21, 2022Taylor Farms Florida, Inc.FoodPossible contamination with Salmonella.Products contains JM Smucker's Jif To Go Natural creamy peanut butter spread NET WT 1.5oz (43g) cups.
May 20, 2022Blue Moose Of Boulder, LLCFoodSpinach Artichoke Cashew Dip was mislabeled with Spinach Artichoke Parmesan Dip label and does not state that the product contains cashews…
May 20, 2022The JM Smucker Company LLCFoodProducts are potentially contaminated with Salmonella.
May 20, 2022The JM Smucker Company LLCFoodProducts are potentially contaminated with Salmonella.

Showing the latest 100 of 161.

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