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FDA Warning Letters, 483s and Recalls: March 2018

FDA enforcement records dated March 2018: 0 warning letters outside tobacco, 48 OAI inspections and 71 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
Mar 30, 2018Almitech, Inc.DevicesUnited States
Mar 30, 2018Eric A. Steckler, M.D.DrugsUnited States
Mar 30, 2018Mariposa Labs, LLCVeterinaryUnited States
Mar 30, 2018Newton Laboratories, Inc.DrugsUnited States
Mar 30, 2018Ridge Properties, LLCDrugsUnited States
Mar 30, 2018Ruby Hall Clinic Ser. Private LimitedDrugsIndia
Mar 30, 2018US Vascular, Inc.DevicesUnited States
Mar 29, 2018Dr. Rajendra Kashinath ShimpiDrugsIndia
Mar 29, 2018Hangzhou Karic Commodities Co., Ltd.DrugsChina
Mar 29, 2018Premier Produce LLCFood/CosmeticsUnited States
Mar 27, 2018Atomvie Global Radiopharma Inc.DrugsCanada
Mar 27, 2018BiB Production & Packaging B.V.DrugsNetherlands
Mar 27, 2018Medicine Invention Design Incorporation IRBDrugsUnited States
Mar 26, 2018Avalon Packaging, Inc.Food/CosmeticsUnited States
Mar 26, 2018Nutreglo Products, LLC.Food/CosmeticsUnited States
Mar 26, 2018Shandong Analysis And Test CenterDrugsChina
Mar 26, 2018Whitsons Food Service (Bronx), LLCFood/CosmeticsUnited States
Mar 23, 2018Jabones Y Productos Especializados SA De CVDrugsMexico
Mar 23, 2018MC Fish CoFood/CosmeticsUnited States
Mar 23, 2018Samuel ZimmermanFood/CosmeticsUnited States
Mar 23, 2018Tata Memorial CentreDrugsIndia
Mar 23, 2018West Coast Nuclear PharmacyDrugsUnited States
Mar 22, 2018Cantrell Drug CompanyDrugsUnited States
Mar 22, 2018Jimmy NesbittVeterinaryUnited States
Mar 22, 2018Leventon S. A. U.DevicesSpain
Mar 22, 2018Niche Pharmaceuticals, IncFood/CosmeticsUnited States
Mar 16, 2018TRIANGLE PHARMANATURALS LLCFood/CosmeticsUnited States
Mar 15, 2018JAKT LLCFood/CosmeticsUnited States
Mar 13, 2018Apollo Care, LLCDrugsUnited States
Mar 13, 2018Product Packaging West, Inc.DrugsUnited States
Mar 12, 2018Defender SD Manufacturing LLCDrugsUnited States
Mar 12, 2018Denterprise International, Inc.DevicesUnited States
Mar 9, 2018E-Z Spuds LLC.Food/CosmeticsUnited States
Mar 9, 2018Holy Land Brand Inc.Food/CosmeticsUnited States
Mar 8, 2018Edge Pharma, LLCDrugsUnited States
Mar 8, 2018Environmental Trade Inc.VeterinaryUnited States
Mar 8, 2018Fair Fish Co IncFood/CosmeticsUnited States
Mar 8, 2018One Way DrugDrugsUnited States
Mar 7, 2018Laboratorios TegorFood/CosmeticsSpain
Mar 7, 2018Sybaritic, IncDevicesUnited States
Mar 6, 2018Molecular Cytogenetics And Genomics LaboratoryVeterinaryUnited States
Mar 5, 2018The Fertility Partnership, LLCBiologicsUnited States
Mar 2, 2018Bamboo LLCFood/CosmeticsUnited States
Mar 2, 2018Gasco Industrial Corp.Food/CosmeticsUnited States
Mar 1, 2018Planet Health Packaging, Inc.Food/CosmeticsUnited States
Mar 1, 2018Pure Source, LLCDrugsUnited States
Mar 1, 2018Surmasis Pharmaceutical, LLCDrugsUnited States
Mar 1, 2018Wilson Medicine CompanyDrugsIndia

Most-cited Form 483 sections

The CFR sections FDA investigators cited most often in inspections that ended this month.

CFR sectionObservationCitations
21 CFR 820.100(a)Lack of or inadequate procedures39
21 CFR 820.198(a)Lack of or inadequate complaint procedures28
21 CFR 1.502(a)Develop FSVP23
21 CFR 117.35(a)Sanitary operations - Plant sanitation22
21 CFR 211.192Written record of investigation incomplete22
21 CFR 211.22(d)Procedures not in writing, fully followed22
21 CFR 117.80(c)Process Control Measures18
21 CFR 820.184Lack of or inadequate DHR procedures18
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures18
21 CFR 123.6(b)No HACCP plan17

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 31, 2018Club 13 Enterprises WarehouseFoodSamples of Maeng Da red powder were tested and resulted positive for Salmonella.
Mar 31, 2018Club 13 Enterprises WarehouseFoodSamples of Maeng Da red powder were tested and resulted positive for Salmonella.
Mar 31, 2018Club 13 Enterprises WarehouseFoodSamples of Maeng Da red powder were tested and resulted positive for Salmonella.
Mar 30, 2018Nutrizone LLCFoodDietary supplements have the potential to be contaminated with Salmonella.
Mar 30, 2018Nutrizone LLCFoodDietary supplements have the potential to be contaminated with Salmonella.
Mar 30, 2018Nutrizone LLCFoodDietary supplements have the potential to be contaminated with Salmonella.
Mar 30, 2018Nutrizone LLCFoodDietary supplements have the potential to be contaminated with Salmonella.
Mar 30, 2018Nutrizone LLCFoodDietary supplements have the potential to be contaminated with Salmonella.
Mar 30, 2018Nutrizone LLCFoodDietary supplements have the potential to be contaminated with Salmonella.
Mar 30, 2018Nutrizone LLCFoodDietary supplements have the potential to be contaminated with Salmonella.
Mar 30, 2018Nutrizone LLCFoodDietary supplements have the potential to be contaminated with Salmonella.
Mar 30, 2018Nutrizone LLCFoodDietary supplements have the potential to be contaminated with Salmonella.
Mar 30, 2018Nutrizone LLCFoodDietary supplements have the potential to be contaminated with Salmonella.
Mar 29, 2018Health NutsFoodProduct may be contaminated with Salmonella.
Mar 28, 2018Independent Nutrition, Inc.FoodIgnite High Endurance Pre-Workout Supplement with Caffeine dietary supplement product is recalled because label declared WHEY protein but…
Mar 28, 2018Independent Nutrition, Inc.FoodEnduravol Elite Pre-Workout dietary supplement product is recalled because label declared WHEY protein but do not declare milk.
Mar 28, 2018Independent Nutrition, Inc.FoodIgnite High Endurance Pre-Workout Supplement Caffeine Free dietary supplement product is recalled because label declared WHEY protein but…
Mar 28, 2018Independent Nutrition, Inc.FoodIgnite High Endurance Pre-Workout Supplement dietary supplement product is recalled because label declared WHEY protein but do not declare…
Mar 28, 2018Independent Nutrition, Inc.FoodIgnite High Endurance Pre-Workout Supplement VANILLA dietary supplement product is recalled because label declared WHEY protein but do not…
Mar 27, 2018First Source, LLCFoodProduct contains undeclared peanuts.
Mar 25, 2018Whole Foods MarketFoodSome decorated (iced) Easter cookies in the shapes of eggs, bunnies and chicks sold in bulk bins in 9 northern CA Whole Foods locations do…
Mar 23, 2018Kwik Trip, Inc.FoodKwik Trip is recalling Kitchen's Cravings Premium Egg Salad Sandwich on Oat Multigrain Bread because it may contain undeclared fish and…
Mar 23, 2018The King Arthur Flour Company, Inc.FoodCoconut flour tested positive for Salmonella.
Mar 22, 2018Becton Dickinson & CompanyDevicesBD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead…
Mar 22, 2018Becton Dickinson & CompanyDevicesBD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead…
Mar 22, 2018Becton Dickinson & CompanyDevicesBD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead…
Mar 22, 2018Becton Dickinson & CompanyDevicesBD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead…
Mar 21, 2018Soap KornerFoodS.K. Herbalist Red MD Kratom powder may be contaminated with Salmonella.
Mar 21, 2018WEIS MARKETSFoodThe ingredient label failed to declare egg because the store-made coleslaw scale label did not list the sub-ingredients of mayonnaise.
Mar 20, 2018Kitchen By The SeaFoodallergen warning not listed on labels, egg, soy & wheat including sulfites
Mar 20, 2018Kitchen By The SeaFoodallergen warning not listed on labels , egg, soy and wheat including sulfites
Mar 20, 2018Maya Distribution, LLCFoodSamples collected by public health officials found the presence of Salmonella.
Mar 20, 2018Maya Distribution, LLCFoodSamples collected by public health officials found the presence of Salmonella.
Mar 20, 2018Maya Distribution, LLCFoodSamples collected by public health officials found the presence of Salmonella.
Mar 20, 2018Maya Distribution, LLCFoodSamples collected by public health officials found the presence of Salmonella.
Mar 19, 2018Tamarack, Inc.FoodTamarack Inc. is recalling Eclipse Kratom-containing powder products because it may be contaminated with Salmonella.
Mar 17, 2018International Harvest, Inc.FoodProduct tested positive for Salmonella.
Mar 16, 2018Aspire Food Group USA Inc.FoodProducts contain undeclared sulfites
Mar 16, 2018Aspire Food Group USA Inc.FoodProducts contain undeclared sulfites
Mar 16, 2018Aspire Food Group USA Inc.FoodProducts contain undeclared sulfites
Mar 16, 2018Natural Grocers By Vitamin CottageFoodCoconut smiles product tested positive for Salmonella.
Mar 16, 2018NGB, CorpFoodNGB Corp is recalling Nxtgen Botanicals due to potential Salmonella contamination.
Mar 16, 2018River Valley SproutsFoodAlfalfa Sprouts have the potential to be contaminated with Salmonella.
Mar 16, 2018River Valley SproutsFoodAlfalfa Sprouts have the potential to be contaminated with Salmonella.
Mar 16, 2018River Valley SproutsFoodAlfalfa Sprouts have the potential to be contaminated with Salmonella.
Mar 16, 2018Taylor Farms California Foodservice, Inc.FoodFirm was notified by direct customer of a confirmed positive result for Salmonella ssp. after routine testing of the diced onion product.
Mar 15, 2018Bayer HealthCare Pharmaceuticals, Inc.DrugsLabeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left…
Mar 14, 2018Davis Chocolate A Division Of Deco Chem, Inc.FoodDavis Chocolate Inc., voluntarily removed organic peanut butter chips from a wholesale account due to a customer's laboratory analysis of…
Mar 14, 2018Vietti Acquisitions, LLCFoodThe firm was notified by a customer that the product contains Dumplings with Chicken. The Dumplings with Chicken contains egg and wheat…
Mar 10, 2018Lancaster Fine Foods Inc.FoodThe firm received a report that 3 cups labeled as Spicy Mayonnaise Sauce was labeled as Thai Sweet Chili Sauce
Mar 10, 2018Wegmans Food Markets, Inc.FoodThe product is labeled as Thai Chili Sauce. The product actually contains Spicy Sauce which contains undeclared egg.
Mar 10, 2018Wegmans Food Markets, Inc.FoodThe product is labeled as Thai Chili Sauce. The product actually contains Spicy Sauce which contains undeclared egg.
Mar 10, 2018Wegmans Food Markets, Inc.FoodThe product is labeled as Thai Chili Sauce. The product actually contains Spicy Sauce which contains undeclared egg.
Mar 9, 2018Avalon PackagingFoodAvalon Packaging is recalling NXTGEN Kratom because of the potential for Salmonella contamination.
Mar 9, 2018Pdx AromaticsFoodKraken Kratom, Phytoextractum, and Soul Speciosa WHITE VEIN Kratom CAPSULES are recalled due to potential contamination with Salmonella.
Mar 9, 2018Pdx AromaticsFoodKraken Kratom, Phytoextractum, and Soul Speciosa RED VEin Kratom Capsule are recalled due to potential contamination with Salmonella.
Mar 9, 2018Pdx AromaticsFoodKraken Kratom, Phytoextractum, and Soul Speciosa GREEN VEIN Kratom CAPSULES are recalled due to potential contamination with Salmonella.
Mar 9, 2018Pdx AromaticsFoodKraken Kratom, Phytoextractum, and Soul Speciosa products containing Red Vein Kratom Powder are recalled due to potential contamination…
Mar 9, 2018Pdx AromaticsFoodKraken Kratom, Phytoextractum, and Soul Speciosa products containing WHITE VEIN Kratom Powder are recalled due to potential contamination…
Mar 9, 2018Pdx AromaticsFoodKraken Kratom, Phytoextractum, and Soul Speciosa GREEN VEIN Kratom POWDER are recalled due to potential contamination with Salmonella.
Mar 8, 2018Jimmy WeberDrugsMarketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the…
Mar 6, 2018Guixens Food Group, Inc.FoodUndeclared Sulfites
Mar 6, 2018M.A.S Food Services CoFoodA sample was collected by the Florida Department of Agriculture and Consumer Services and the analysis revealed that the product contains…
Mar 6, 2018Piggie Park Enterprises IncFoodUndeclared soy and wheat ingredients
Mar 6, 2018Starwest Botanicals, IncFoodCustomer notified firm after they received a positive result for Salmonella of Lot #90186-00 Cardamon Pods Green Whole Organic supplied by…
Mar 5, 2018Good Fields Farm/The Maiden's CreameryFoodThe firm recalled cheese after a sample tested positive for Listeria monocytogenes by the State of New York.
Mar 1, 2018Draeger Medical, Inc.DevicesThe automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual…
Mar 1, 2018Draeger Medical, Inc.DevicesThe automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual…
Mar 1, 2018Draeger Medical, Inc.DevicesThe automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual…
Mar 1, 2018Draeger Medical, Inc.DevicesThe automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual…
Mar 1, 2018WEIS MARKETSFoodLabel did not list sub-ingredients for mayo and sour cream. It contains undeclared egg and milk. The firm found a 2nd PLU which was not…

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.