Home / Months / December 2018

FDA Warning Letters, 483s and Recalls: December 2018

FDA enforcement records dated December 2018: 0 warning letters outside tobacco, 35 OAI inspections and 108 Class I recalls. FDA publishes some records weeks after their date, so recent months can still grow.

· All months ·

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
Dec 22, 2018Glint Cosmetics Private LtdDrugsIndia
Dec 21, 2018Jurox Pty LtdVeterinaryAustralia
Dec 21, 2018Petra Hygienic Systems Int LtdDrugsCanada
Dec 20, 2018Joseph AndersonTobaccoUnited States
Dec 19, 2018Captain Alex Seafood, Ltd.Food/CosmeticsUnited States
Dec 19, 2018Lystn, LLCVeterinaryUnited States
Dec 19, 2018Pine Lane FarmsVeterinaryUnited States
Dec 18, 2018Exercore, LLCDevicesUnited States
Dec 18, 2018Jubilant Pharmova LimitedDrugsIndia
Dec 18, 2018LNZRO Pizza Empire IncFood/CosmeticsUnited States
Dec 18, 2018Unipack LLCDrugsUnited States
Dec 18, 2018Wetters Distributing, IncFood/CosmeticsUnited States
Dec 18, 2018X TECH CO-PACKERS, LLCDrugsUnited States
Dec 18, 2018Ziegler Dairy Farm Inc.VeterinaryUnited States
Dec 17, 2018Landmark Foods, LLCFood/CosmeticsUnited States
Dec 14, 2018Barclay, Luke, & Pillai Specialty Pharmacy, PLLCDrugsUnited States
Dec 14, 2018EL MAGUEY DORADO CORPORATIONFood/CosmeticsUnited States
Dec 14, 2018Erchonia Corporation, LLCDevicesUnited States
Dec 14, 2018Herman's NutHouse, LLCFood/CosmeticsUnited States
Dec 14, 2018Luen Fook Medicine Sdn. Bhd.DrugsMalaysia
Dec 13, 2018Evol Nutrition Associates, Inc.Food/CosmeticsUnited States
Dec 13, 2018Frozen Products Corporation S.A.C.Food/CosmeticsPeru
Dec 13, 2018Grand Strand Sandwich Company, Inc.Food/CosmeticsUnited States
Dec 13, 2018Kitron ABDevicesSweden
Dec 13, 2018Sunshine Mills, Inc.VeterinaryUnited States
Dec 13, 2018Vida International, Inc.DrugsTaiwan
Dec 12, 2018Somalabs, IncFood/CosmeticsUnited States
Dec 11, 2018Allied Vision Group IncDevicesUnited States
Dec 10, 2018Seaway Pharma Inc.DrugsUnited States
Dec 6, 2018Davis Ventures, Inc.Food/CosmeticsUnited States
Dec 6, 2018INGENUE CAREDrugsUnited States
Dec 6, 2018J & M Urinary Catheters, LLCDevicesUnited States
Dec 4, 2018LGM Pharma LLCDrugsUnited States
Dec 4, 2018Lupin LimitedDrugsIndia
Dec 4, 2018Philips North America, LLCDevicesUnited States

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 procedures30
21 CFR 820.198(a)Lack of or inadequate complaint procedures28
21 CFR 1.502(a)Develop FSVP26
21 CFR 117.10Personnel25
21 CFR 117.35(a)Sanitary operations - Plant sanitation23
21 CFR 117.80(c)Process Control Measures18
21 CFR 211.22(d)Procedures not in writing, fully followed17
21 CFR 211.192Written record of investigation incomplete16
21 CFR 117.40Equipment and utensils - Design and maintenance14
FDCA 402(a)(4)System for administration of drugs14

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
Dec 28, 2018Salmon River Foods IncFoodThe 1.25 oz Forest Wild Wolf Dark Chocolate bars are recalled due to undeclared milk
Dec 26, 2018WEST PHARMA. SERVICES IL, LTDDevicesAdverse events have been reported with the use of oxytocin in conjunction with the product in pregnant women. There is a possibility that…
Dec 26, 2018WEST PHARMA. SERVICES IL, LTDDevicesAdverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. Vial2Bag is recalled…
Dec 26, 2018WEST PHARMA. SERVICES IL, LTDDevicesAdverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. Vial2Bag DC 20mm is…
Dec 21, 2018Bornstein Seafoods IncFood5-pound cans of unpasteurized, reduced oxygen packaged (ROP), ready-to-eat, Dungeness crab meat are recalled because the incorrect Time…
Dec 21, 2018Chocolate Therapist, TheFoodChocolate Rx The Purist may contain milk solids.
Dec 21, 2018Dakota Specialty Milling, IncFoodAn ingredient in the blended products has the potential to be contaminated with Salmonella.
Dec 21, 2018Dakota Specialty Milling, IncFoodAn ingredient in the blended products has the potential to be contaminated with Salmonella.
Dec 21, 2018Draeger Medical, Inc.DevicesIncorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Dec 21, 2018Draeger Medical, Inc.DevicesIncorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Dec 21, 2018Draeger Medical, Inc.DevicesIncorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Dec 21, 2018Draeger Medical, Inc.DevicesIncorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Dec 21, 2018Draeger Medical, Inc.DevicesIncorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Dec 21, 2018Draeger Medical, Inc.DevicesIncorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Dec 21, 2018Draeger Medical, Inc.DevicesIncorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Dec 21, 2018Draeger Medical, Inc.DevicesIncorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Dec 21, 2018Draeger Medical, Inc.DevicesIncorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Dec 21, 2018Edwards Lifesciences, LLCDevicesThese Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may…
Dec 21, 2018Edwards Lifesciences, LLCDevicesThese Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may…
Dec 21, 2018Edwards Lifesciences, LLCDevicesThese Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may…
Dec 21, 2018Edwards Lifesciences, LLCDevicesThese Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may…
Dec 21, 2018Pennant IngredientsFoodProduct may be contaminated with Salmonella.
Dec 21, 2018Southwind Foods LLC Dba Great American Seafood Imports Co.FoodCrab meat recalled by supplier due to potential temperature abuse.
Dec 21, 2018US GypsumFoodPotential for the inclusion of Salmonella in the product.
Dec 20, 2018Funky Chunky LLCFoodNutty Choco Pop has in incorrect label and does not declare that it contains cashews and almonds.
Dec 20, 2018Lupin Pharmaceuticals Inc.DrugsPresence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the…
Dec 20, 2018Lupin Pharmaceuticals Inc.DrugsPresence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the…
Dec 20, 2018Lupin Pharmaceuticals Inc.DrugsPresence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the…
Dec 20, 2018Lupin Pharmaceuticals Inc.DrugsPresence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the…
Dec 20, 2018TERRIFIC CARE LLCDevicesPotential for abnormally high INR test results with the CoaguChek XS PT Test Strips for customers who purchased products directly from…
Dec 18, 2018Produce Packaging IncFoodFirm received notification from supplier of potential for contamination with E.coli.
Dec 18, 2018Produce Packaging IncFoodFirm received notification from supplier of potential for contamination with E.coli.
Dec 18, 2018Produce Packaging IncFoodFirm received notification from supplier of potential for contamination with E.coli.
Dec 18, 2018Produce Packaging IncFoodFirm received notification from supplier of potential for contamination with E.coli.
Dec 18, 2018Produce Packaging IncFoodFirm received notification from supplier of potential for contamination with E.coli.
Dec 18, 2018Produce Packaging IncFoodFirm received notification from supplier of potential for contamination with E.coli.
Dec 18, 2018Produce Packaging IncFoodFirm received notification from supplier of potential for contamination with E.coli.
Dec 18, 2018Produce Packaging IncFoodFirm received notification from supplier of potential for contamination with E.coli.
Dec 18, 2018Produce Packaging IncFoodFirm received notification from supplier of potential for contamination with E.coli.
Dec 18, 2018Produce Packaging IncFoodFirm received notification from supplier of potential for contamination with E.coli.
Dec 18, 2018Produce Packaging IncFoodFirm received notification from supplier of potential for contamination with E.coli.
Dec 18, 2018Produce Packaging IncFoodFirm received notification from supplier of potential for contamination with E.coli..
Dec 18, 2018Produce Packaging IncFoodFirm received notification from supplier of potential for contamination with E.coli.
Dec 18, 2018Produce Packaging IncFoodFirm received notification from supplier of potential for contamination with E.coli.
Dec 18, 2018Produce Packaging IncFoodFirm received notification from supplier of potential for contamination with E.coli.
Dec 18, 2018Produce Packaging IncFoodFirm received notification from supplier of potential for contamination with E.coli.
Dec 18, 2018Produce Packaging IncFoodFirm received notification from supplier of potential for contamination with E.coli.
Dec 18, 2018Produce Packaging IncFoodFirm received notification from supplier of potential for contamination with E.coli.
Dec 18, 2018Produce Packaging IncFoodFirm received notification from supplier of potential for contamination with E.coli.
Dec 18, 2018Produce Packaging IncFoodFirm received notification from supplier of potential for contamination with E.coli.
Dec 18, 2018Produce Packaging IncFoodFirm received notification from supplier of potential for contamination with E.coli.
Dec 18, 2018Produce Packaging IncFoodFirm received notification from supplier of potential for contamination with E.coli.
Dec 17, 2018Oskri Corp.FoodSunflower and Tahini Butter has the potential to be contaminated with Listeria monocytogenes. EXPANDED1/21/2019 Recall was expanded to…
Dec 17, 2018Oskri Corp.FoodSunflower and Tahini Butter has the potential to be contaminated with Listeria monocytogenes. EXPANDED1/21/2019 Recall was expanded to…
Dec 17, 2018Oskri Corp.FoodSunflower and Tahini Butter has the potential to be contaminated with Listeria monocytogenes. EXPANDED1/21/2019 Recall was expanded to…
Dec 17, 2018Oskri Corp.FoodSunflower and Tahini Butter has the potential to be contaminated with Listeria monocytogenes. EXPANDED1/21/2019 Recall was expanded to…
Dec 17, 2018Oskri Corp.FoodSunflower and Tahini Butter has the potential to be contaminated with Listeria monocytogenes. EXPANDED1/21/2019 Recall was expanded to…
Dec 17, 2018Oskri Corp.FoodSunflower and Tahini Butter has the potential to be contaminated with Listeria monocytogenes. EXPANDED1/21/2019 Recall was expanded to…
Dec 17, 2018Oskri Corp.FoodSunflower and Tahini Butter has the potential to be contaminated with Listeria monocytogenes. EXPANDED1/21/2019 Recall was expanded to…
Dec 17, 2018Oskri Corp.FoodSunflower and Tahini Butter has the potential to be contaminated with Listeria monocytogenes. EXPANDED1/21/2019 Recall was expanded to…
Dec 17, 2018Oskri Corp.FoodSunflower and Tahini Butter has the potential to be contaminated with Listeria monocytogenes. EXPANDED1/21/2019 Recall was expanded to…
Dec 17, 2018Oskri Corp.FoodSunflower and Tahini Butter has the potential to be contaminated with Listeria monocytogenes. EXPANDED1/21/2019 Recall was expanded to…
Dec 17, 2018Oskri Corp.FoodSunflower and Tahini Butter has the potential to be contaminated with Listeria monocytogenes. EXPANDED1/21/2019 Recall was expanded to…
Dec 17, 2018Oskri Corp.FoodSunflower and Tahini Butter has the potential to be contaminated with Listeria monocytogenes. EXPANDED1/21/2019 Recall was expanded to…
Dec 17, 2018Oskri Corp.FoodSunflower and Tahini Butter has the potential to be contaminated with Listeria monocytogenes. EXPANDED1/21/2019 Recall was expanded to…
Dec 17, 2018Oskri Corp.FoodSunflower and Tahini Butter has the potential to be contaminated with Listeria monocytogenes. EXPANDED1/21/2019 Recall was expanded to…
Dec 17, 2018Oskri Corp.FoodSunflower and Tahini Butter has the potential to be contaminated with Listeria monocytogenes. EXPANDED1/21/2019 Recall was expanded to…
Dec 17, 2018Oskri Corp.FoodSunflower and Tahini Butter has the potential to be contaminated with Listeria monocytogenes. EXPANDED1/21/2019 Recall was expanded to…
Dec 17, 2018Oskri Corp.FoodSunflower and Tahini Butter has the potential to be contaminated with Listeria monocytogenes. EXPANDED1/21/2019 Recall was expanded to…
Dec 17, 2018Oskri Corp.FoodSunflower and Tahini Butter has the potential to be contaminated with Listeria monocytogenes. EXPANDED1/21/2019 Recall was expanded to…
Dec 17, 2018Oskri Corp.FoodSunflower and Tahini Butter has the potential to be contaminated with Listeria monocytogenes. EXPANDED1/21/2019 Recall was expanded to…
Dec 17, 2018Oskri Corp.FoodSunflower and Tahini Butter has the potential to be contaminated with Listeria monocytogenes. EXPANDED1/21/2019 Recall was expanded to…
Dec 16, 2018Atherstone Foods, Inc. Dba Glass Onion CateringFoodDuring internal review is was discovered that the incorrect dressing was used in production of a vegetable wrap that does not declare soy…
Dec 15, 2018Apio, Inc.FoodCanadian Food Inspection Agency notified firm of positive finding Listeria Monocytogenes in several varieties of Eat Smart Single-Serve…
Dec 15, 2018Apio, Inc.FoodCanadian Food Inspection Agency notified firm of positive finding Listeria Monocytogenes in several varieties of Eat Smart Single-Serve…
Dec 15, 2018Apio, Inc.FoodCanadian Food Inspection Agency notified firm of positive finding Listeria Monocytogenes in several varieties of Eat Smart Single-Serve…
Dec 15, 2018Apio, Inc.FoodCanadian Food Inspection Agency notified firm of positive finding Listeria Monocytogenes in several varieties of Eat Smart Single-Serve…
Dec 15, 2018Apio, Inc.FoodCanadian Food Inspection Agency notified firm of positive finding Listeria Monocytogenes in several varieties of Eat Smart Single-Serve…
Dec 14, 2018Results RNA, LLCDrugsLack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
Dec 14, 2018Spokane Produce IncFoodThe sandwiches made with green leaf are recalled due to a potential to be contaminated with E. Coli O157:H7.
Dec 14, 2018Spokane Produce IncFoodThe sandwiches were made with green leaf and were recalled due to a potential to be contaminated with E. Coli O157:H7.
Dec 14, 2018Spokane Produce IncFoodThe sandwiches were made with green leaf and were recalled due to a potential to be contaminated with E. Coli O157:H7.
Dec 14, 2018Spokane Produce IncFoodThe sandwiches were made with green leaf and were recalled due to a potential to be contaminated with E. Coli O157:H7.
Dec 14, 2018Spokane Produce IncFoodThe red leaf lettuce heads are recalled due to a potential to be contaminated with E. Coli O157:H7.
Dec 14, 2018Spokane Produce IncFoodThe sandwiches were made with green leaf and were recalled due to a potential to be contaminated with E. Coli O157:H7.
Dec 14, 2018Spokane Produce IncFoodThe sandwiches were made with green leaf and were recalled due to a potential to be contaminated with E. Coli O157:H7.
Dec 14, 2018Spokane Produce IncFoodThe sandwiches were made with green leaf and were recalled due to a potential to be contaminated with E. Coli O157:H7.
Dec 14, 2018Spokane Produce IncFoodThe sandwiches were made with green leaf and were recalled due to a potential to be contaminated with E. Coli O157:H7.
Dec 14, 2018Spokane Produce IncFoodThe sandwiches were made with green leaf and were recalled due to a potential to be contaminated with E. Coli O157:H7.
Dec 14, 2018Spokane Produce IncFoodThe sandwiches were made with green leaf and were recalled due to a potential to be contaminated with E. Coli O157:H7.
Dec 14, 2018Spokane Produce IncFoodThe green leaf lettuce fillets and heads are recalled due to a potential to be contaminated with E. Coli O157:H7.
Dec 13, 2018Adam Bros. Farming, Inc.FoodPotential E. coli O157:H7 contamination.
Dec 13, 2018Adam Bros. Farming, Inc.FoodPotential E. coli O157:H7 contamination.
Dec 13, 2018Adam Bros. Farming, Inc.FoodPotential E. coli O157:H7 contamination.
Dec 11, 2018Asclemed USA Inc. Dba EnovachemDrugsLabeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product…
Dec 11, 2018Asclemed USA Inc. Dba EnovachemDrugsLabeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product…
Dec 11, 2018Lipari Foods Operating Company, LLCFoodProduct testing returned positive test results for Listeria monocytogenes.
Dec 11, 2018Lipari Foods Operating Company, LLCFoodProduct testing returned positive test results for Listeria monocytogenes.
Dec 11, 2018Lipari Foods Operating Company, LLCFoodProduct testing returned positive test results for Listeria monocytogenes.
Dec 11, 2018Lipari Foods Operating Company, LLCFoodProduct testing returned positive test results for Listeria monocytogenes.

Showing the latest 100 of 108.

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.