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FDA Warning Letters, 483s and Recalls: March 2022

FDA enforcement records dated March 2022: 41 warning letters outside tobacco (plus 19 tobacco letters), 56 OAI inspections and 53 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
Mar 31, 2022OsteoLife Biomedical I LLCOffice of Biological Products Operations – Division IDeviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Mar 31, 2022Vi-Jon, LLCDivision of Pharmaceutical Quality Operations IIICGMP/Finished Pharmaceuticals/Adulterated
Mar 30, 2022Kubapharm.ComCenter for Drug Evaluation and Research | CDERUnlawful Sale of Schedule II Stimulants to Consumers over the Internet
Mar 30, 2022Premiumlightsupplier.ComCenter for Drug Evaluation and Research | CDERUnlawful Sale of Schedule II Stimulants to Consumers over the Internet
Mar 30, 2022Verde Cosmetic Labs LLCDivision of Pharmaceutical Quality Operations IVCGMP/Finished Pharmaceuticals/Adulterated
Mar 28, 2022Bhan Kanom Thai IncDivision of West Coast ImportsForeign Supplier Verification Program (FSVP)
Mar 28, 2022CBD SocialCenter for Drug Evaluation and Research | CDERUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Mar 28, 2022CureganicsCenter for Drug Evaluation and Research | CDERUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Mar 28, 2022Functional Remedies, LLC D/B/A Synchronicity Hemp OilCenter for Drug Evaluation and Research | CDERUnapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)
Mar 28, 2022Greenway Herbal Products LLCCenter for Drug Evaluation and Research | CDERUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Mar 28, 2022Heaven’S Organic LLCCenter for Drug Evaluation and Research | CDERUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Mar 28, 2022LECS USA Inc.Division of West Coast ImportsForeign Supplier Verification Program (FSVP)
Mar 28, 2022Madras GroceriesDivision of West Coast ImportsForeign Supplier Verification Program (FSVP)
Mar 28, 2022Nature's HighwayCenter for Drug Evaluation and Research | CDERUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Mar 28, 2022NDAL Mfg Inc.Division of Pharmaceutical Quality Operations IVCGMP/Finished Pharmaceuticals/Adulterated
Mar 28, 2022UPSY LLCCenter for Drug Evaluation and Research | CDERUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Mar 25, 2022Agropharma Laboratories, Inc.Office of Pharmaceutical Quality Operations, Division IICGMP/Finished Pharmaceuticals/Adulterated
Mar 25, 2022Iodine Products IncCenter for Drug Evaluation and Research | CDERUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Mar 24, 2022Applied Biological Laboratories Inc.Center for Drug Evaluation and Research | CDERUnapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)
Mar 24, 2022Northeast Seafood Products, Inc.Office of Human and Animal Food Operations Division West 4Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Mar 18, 2022Med Shop Total Care, Inc.Office of Pharmaceutical Quality Operations, Division IICompounding Pharmacy/Adulterated Drug Products
Mar 17, 2022Honey Feast, Inc.Office of Human and Animal Food Operations East Division IVNew Drug/Misbranded
Mar 17, 2022Vitae Enim Vitae Scientific Inc.Division of Pharmaceutical Quality Operations IVCGMP/Finished Pharmaceuticals/Adulterated
Mar 15, 2022Iotech International, LLCCenter for Drug Evaluation and Research | CDERUnapproved New Drug and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Mar 14, 2022Dr Retter Ec Wladyslaw RetterCenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Mar 14, 2022Langlinais’ Baking CompanyOffice of Human and Animal Foods Operations-EastCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Mar 14, 2022Premier Trends LLCDivision of Pharmaceutical Quality Operations ICGMP/Finished Pharmaceuticals/Adulterated
Mar 14, 2022Ultra Seal CorporationOffice of Pharmaceutical Quality OperationsCGMP/Finished Pharmaceuticals/Adulterated
Mar 11, 2022Agroson’S LLCDivision of Northeast ImportsForeign Supplier Verification Program (FSVP)
Mar 11, 2022CAJ Food Products Inc.Office of Human and Animal Food Operations East Division 6New Drug/Misbranded
Mar 11, 2022Don’T Run Out Dba Public GoodsDivision of Northeast ImportsForeign Supplier Verification Program (FSVP)
Mar 10, 2022Soda PharmCenter for Drug Evaluation and Research | CDERUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Mar 9, 2022GW FOOD USA Inc.Division of West Coast ImportsForeign Supplier Verification Program (FSVP)
Mar 8, 2022Apna Foods Imports Co.Division of Northern Border ImportsForeign Supplier Verification Program (FSVP)
Mar 8, 2022Purina Animal Nutrition LLCDivision of Human and Animal Food Operations West IIICGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Mar 7, 2022Sunshine Mills, IncHuman and Animal Food East V Compliance Branch (HAFE5-CB)CGMP/Animal Food/Adulterated
Mar 7, 2022Viraldine, LLCCenter for Drug Evaluation and Research | CDERUnapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)
Mar 4, 2022Medina Baking And Powder Products, Inc.Office of Human and Animal Food Operations Division IV EastFood Labeling/Misbranded
Mar 2, 2022Keeler Family FarmsDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Mar 1, 2022Clinical Resolution Laboratory Inc.Division of Pharmaceutical Quality Operations IVCGMP/Finished Pharmaceuticals/Adulterated
Mar 1, 2022Generitech CorporationDivision of Pharmaceutical Quality Operations IVCGMP/Finished Pharmaceuticals/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
Mar 31, 2022Sanitizer Supply LLCDrugsUnited States
Mar 30, 2022DF Global, Inc.Food/CosmeticsUnited States
Mar 30, 2022Lucky's Convenience & Tobacco, LLCTobaccoUnited States
Mar 30, 2022Mahina Mele Farms LLCFood/CosmeticsUnited States
Mar 30, 2022Seditious Vapours LLCTobaccoUnited States
Mar 30, 2022SUPREME FRUIT PRODUCE INC.Food/CosmeticsUnited States
Mar 30, 2022The Vapor Craft LLCTobaccoUnited States
Mar 29, 2022ImmuCell CorporationVeterinaryUnited States
Mar 28, 2022American Cleaning SolutionsDrugsUnited States
Mar 25, 2022Elvi Pharma LLCDrugsUnited States
Mar 25, 2022Soul Vapor, LLCTobaccoUnited States
Mar 25, 2022Unipack LLCDrugsUnited States
Mar 24, 2022CHICAGO SWEET CONNECTION, INC.Food/CosmeticsUnited States
Mar 24, 2022DING TEA BALBOAFood/CosmeticsUnited States
Mar 24, 2022Eco Lips, Inc.DrugsUnited States
Mar 24, 2022Morin EnterprisesTobaccoUnited States
Mar 23, 2022Best Choice Confectionary Inc.Food/CosmeticsUnited States
Mar 23, 2022Mercado Hispano Distributors, LLCFood/CosmeticsUnited States
Mar 22, 2022DN Imports, IncFood/CosmeticsUnited States
Mar 22, 2022Invitrx Therapeutics Inc.BiologicsUnited States
Mar 21, 2022Banks Square Market CorpFood/CosmeticsUnited States
Mar 18, 2022Abbott LaboratoriesFood/CosmeticsUnited States
Mar 18, 2022National Food Industries, LLCFood/CosmeticsUnited Arab Emirates
Mar 17, 2022American Chinese Natural Herbs, Inc.Food/CosmeticsUnited States
Mar 17, 2022Brad Grate Dairy FarmVeterinaryUnited States
Mar 17, 2022Daxa Foods, Inc.Food/CosmeticsUnited States
Mar 17, 2022Ocho Rios-Miami, Inc.Food/CosmeticsUnited States
Mar 15, 2022Advance-Esthetic LLCDevicesUnited States
Mar 15, 2022Nova-Tech, Inc.VeterinaryUnited States
Mar 15, 2022USA Medical, LLCDevicesUnited States
Mar 15, 2022WINFULL CORPORATIONFood/CosmeticsUnited States
Mar 14, 2022BMF, Inc.Food/CosmeticsUnited States
Mar 14, 2022Dara Food LLCFood/CosmeticsUnited States
Mar 11, 2022Charanga Catering, LLCFood/CosmeticsUnited States
Mar 11, 2022Episciences IncDrugsUnited States
Mar 11, 2022Family Pharmacy Of StatesvilleDrugsUnited States
Mar 11, 2022Flores Produce, Inc.Food/CosmeticsUnited States
Mar 11, 2022KAKAW MANUFACTURING CO LLCFood/CosmeticsUnited Arab Emirates
Mar 11, 2022VIRGIN SCENT INCDrugsUnited States
Mar 10, 2022Bella Rosa Distribution, Inc.Food/CosmeticsUnited States
Mar 10, 2022Gordon Laboratories IncDrugsUnited States
Mar 10, 2022North American Custom Laboratories, LLCDrugsUnited States
Mar 9, 2022Brunkow Cheese Of Wisconsin, Inc.Food/CosmeticsUnited States
Mar 9, 2022Jap Inc.Food/CosmeticsUnited States
Mar 9, 2022West Coast Cosmetics IncDrugsUnited States
Mar 9, 2022Wick 'N' Vape, LLCTobaccoUnited States
Mar 8, 2022Arizona Hydroponic Farming, LLCFood/CosmeticsUnited States
Mar 8, 2022Cryos International USA, LLCBiologicsUnited States
Mar 8, 2022Rong Shing Trading NY IncFood/CosmeticsUnited States
Mar 8, 2022VidasoyFood/CosmeticsUnited States
Mar 7, 2022Expert Chemical Analysis, Inc.DrugsUnited States
Mar 4, 2022La Ilusion Fresh Guava Inc.Food/CosmeticsUnited States
Mar 4, 2022Zhejiang Tianyu Pharmaceutical Co LtdDrugsChina
Mar 4, 2022ZHOUSHAN HAICHANG FOOD CO.,LTD.Food/CosmeticsChina
Mar 3, 2022IDC USA INCFood/CosmeticsUnited States
Mar 1, 2022Eosera, Inc.DrugsUnited 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 FSVP91
21 CFR 117.35(a)Sanitary operations - Plant sanitation38
21 CFR 117.40Equipment and utensils - Design and maintenance29
21 CFR 820.100(a)Lack of or inadequate procedures25
21 CFR 1.505(a)(2)Evaluation - performance, risk23
21 CFR 1.506(b)Supplier verification - establish written procedures21
21 CFR 117.35(c)Pest control20
21 CFR 117.10Personnel19
21 CFR 211.192Written record of investigation incomplete18
21 CFR 117.80(c)Process Control Measures17

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
Mar 30, 2022Abbott VascularDevicesThere is a potential that the proximal marker may separate from the imaging catheter
Mar 30, 2022Unilever United States Inc.DrugsChemical contamination: presence of benzene
Mar 29, 2022Best Brands Consumer Products, Inc.DrugsChemical Contamination; FDA analysis found product to contain methanol
Mar 29, 2022Best Brands Consumer Products, Inc.DrugsChemical Contamination; FDA analysis found product to contain benzene
Mar 29, 2022Giant Eagle, Inc.FoodUndeclared milk allergen
Mar 29, 2022Giant Eagle, Inc.FoodUndeclared milk allergen
Mar 29, 2022Pink ToyzDrugsMarketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil, an ingredient found in FDA approved…
Mar 29, 2022Teva Pharmaceuticals USA IncDrugsPresence of Particulate Matter: Product was found to contain silica and iron oxide
Mar 28, 2022Groundwork Coffee LLCFoodOregon Department of Agriculture found that allergens were not properly declared during inspection.
Mar 25, 2022Medtronic Formerly CovidienDevicesThe audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states. Delayed awareness of…
Mar 24, 2022Plastikon Healthcare LLCDrugsMicrobial Contamination of Non-Sterile Products
Mar 24, 2022Plastikon Healthcare LLCDrugsMicrobial Contamination of Non-Sterile Products
Mar 23, 2022WISETRADE CORPORATIONFoodCalifornia Department of Public Health sampled Enoki mushrooms and found contamination with Listeria monocytogenes.
Mar 22, 2022Farm Fresh Produce LLCFoodCalifornia Department of Public Health of Public Health sampled product and found it to contain Listeria monocytogenes.
Mar 21, 2022A & C Best Food TradingFoodProduct contains undeclared sulfites.
Mar 21, 2022A & C Best Food TradingFoodProduct contains undeclared sulfites and unallowed dye - Amaranth (E123) - Acid Red 27
Mar 21, 2022Adamis Pharmaceuticals CorporationDrugsDefective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Mar 21, 2022Adamis Pharmaceuticals CorporationDrugsDefective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Mar 21, 2022Avanos Medical, Inc.DevicesProduct labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement…
Mar 18, 2022Fruit Fresh Up, Inc.Foodmay be contaminated with Listeria monocytogenes
Mar 18, 2022Fruit Fresh Up, Inc.Foodmay be contaminated with Listeria monocytogenes
Mar 18, 2022Fruit Fresh Up, Inc.Foodmay be contaminated with Listeria monocytogenes
Mar 18, 2022Fruit Fresh Up, Inc.Foodmay be contaminated with Listeria monocytogenes
Mar 18, 2022Fruit Fresh Up, Inc.Foodmay be contaminated with Listeria monocytogenes
Mar 18, 2022Fruit Fresh Up, Inc.Foodmay be contaminated with Listeria monocytogenes
Mar 18, 2022Fruit Fresh Up, Inc.Foodmay be contaminated with Listeria monocytogenes
Mar 18, 2022Fruit Fresh Up, Inc.Foodmay be contaminated with Listeria monocytogenes
Mar 18, 2022Fruit Fresh Up, Inc.Foodmay be contaminated with Listeria monocytogenes
Mar 18, 2022Fruit Fresh Up, Inc.Foodmay be contaminated with Listeria monocytogenes
Mar 18, 2022Fruit Fresh Up, Inc.Foodmay be contaminated with Listeria monocytogenes
Mar 18, 2022Fruit Fresh Up, Inc.Foodmay be contaminated with Listeria monocytogenes
Mar 18, 2022Jan Fruits, Inc.FoodCalifornia Department of Public Health sampled product and results showed the presence of Listeria monocytogenes.
Mar 18, 2022Liberty Fruit Co Inc DBA Carol's CutsFoodFresh-cut cantaloupe positive for Salmonella.
Mar 18, 2022Liberty Fruit Co Inc DBA Carol's CutsFoodFresh-cut cantaloupe positive for Salmonella.
Mar 18, 2022Liberty Fruit Co Inc DBA Carol's CutsFoodFresh-cut cantaloupe positive for Salmonella.
Mar 18, 2022Liberty Fruit Co Inc DBA Carol's CutsFoodFresh-cut cantaloupe positive for Salmonella.
Mar 18, 2022T Fresh Company DBA Yes ProduceFoodCalifornia Department of Public Health sampled product with a result of Listeria monocytogenes
Mar 18, 2022The Salsa TexanFoodPotential to contain undeclared wheat and whey
Mar 18, 2022Top Quality Produce, IncFoodCalifornia Department of Public Health tested Enoki mushrooms and had a positive result for Listeria monocytogenes.
Mar 15, 2022Laura Chenel's Chevre, Inc.FoodUndeclared Egg.
Mar 14, 2022Sensory Medical IncDevicesDue potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021.
Mar 13, 2022Cavendish FarmsFoodUndeclared barley and wheat flour
Mar 9, 2022Albanese Confectionery Group, Inc.FoodUndeclared Allergen - Peanut
Mar 8, 2022Jubilant Cadista Pharmaceuticals, Inc.DrugsLabeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles…
Mar 4, 2022Fagron, IncDrugsMicrobial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Mar 4, 2022Fresenius Kabi USA, LLCDrugsPresence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium…
Mar 4, 2022SML Distribution, LLCDevicesThe product was distributed without FDA authorization or clearance for marketing and distribution in the US.
Mar 3, 2022Atrium Medical CorporationDevicesFirm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter…
Mar 3, 2022Atrium Medical CorporationDevicesFirm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter…
Mar 3, 2022Tennessee Technical Coatings, Corp.DrugsChemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol.
Mar 3, 2022Torn & Glasser, Inc.FoodPackaged of Dark Chococlate Covered Cherries may contain Dark Chocolate covered almonds. Undeclared allergen - tree nuts (almonds).
Mar 3, 2022Tova Industries IncFoodUndeclared Allergen- Milk
Mar 2, 2022Medtronic IncDevicesThere is potential for the capsule bond to break during the procedure.

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.