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FDA Warning Letters, 483s and Recalls: December 2019

FDA enforcement records dated December 2019: 0 warning letters outside tobacco, 33 OAI inspections and 98 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
Dec 31, 2019Hampshire Labs, Inc.Food/CosmeticsUnited States
Dec 20, 2019Matthew 7:25 IncDrugsUnited States
Dec 20, 2019Signa S.A. De C.V.DrugsMexico
Dec 19, 2019Aquavit Life Sciences, Inc.DevicesUnited States
Dec 19, 2019Desarrollo E Investigacion Medica Aragonesa SLDevicesSpain
Dec 19, 2019WK Kellogg CoFood/CosmeticsUnited States
Dec 18, 2019BioLyte Laboratories, LLCDrugsUnited States
Dec 18, 2019Cosco International, Inc.TobaccoUnited States
Dec 17, 2019CV East, LLCFood/CosmeticsUnited States
Dec 17, 2019Monfitello Inc.Food/CosmeticsCanada
Dec 17, 2019Patel, Vikas V.DevicesUnited States
Dec 13, 2019Almark Foods, LLCFood/CosmeticsUnited States
Dec 13, 2019Greiner Bio-One North America, Inc.DevicesUnited States
Dec 13, 2019Hakim CharfiDrugsFrance
Dec 13, 2019Sicor De Mexico S.A. De C.V.DrugsMexico
Dec 13, 2019Sun Pharmaceutical Industries Ltd.DrugsIndia
Dec 13, 2019Tenderneeds Fertility LLCBiologicsUnited States
Dec 12, 2019Catsmo, LLCFood/CosmeticsUnited States
Dec 11, 2019LifeHealth ScienceFood/CosmeticsUnited States
Dec 11, 2019NutraCap Holdings LLCFood/CosmeticsUnited States
Dec 6, 2019Avenue Pharmacy IncDrugsUnited States
Dec 6, 2019BOEHRINGER INGELHEIM PROMECO S.A. De C.V.DrugsMexico
Dec 6, 2019Cartibras Beneficiadora De Produtos Animais LtdaDrugsBrazil
Dec 6, 2019Grato Holdings, Inc.DrugsUnited States
Dec 6, 2019Marcus Research Laboratory, Inc.VeterinaryUnited States
Dec 6, 2019Portland Sandwich Co.Food/CosmeticsUnited States
Dec 6, 2019Surgery Pharmacy Services IncDrugsUnited States
Dec 5, 2019Mark Berman, M.D.DevicesUnited States
Dec 5, 2019Steamboat Seafood Company, IncorporatedFood/CosmeticsUnited States
Dec 5, 2019Sunrise Distributors IncFood/CosmeticsUnited States
Dec 4, 2019Fuji Food Products, Inc.Food/CosmeticsUnited States
Dec 3, 2019Assurance InfusionDrugsUnited States
Dec 2, 2019Implant Direct Sybron Manufacturing 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 1.502(a)FSVP assurances38
21 CFR 117.35(a)Sanitary operations - Plant sanitation29
21 CFR 820.100(a)Lack of or inadequate procedures29
21 CFR 123.11(b)Sanitation monitoring documentation23
21 CFR 820.198(a)Lack of or inadequate complaint procedures19
21 CFR 117.130(a)(1)Hazard Analysis - Identification of Hazard17
21 CFR 123.6(b)No HACCP plan17
21 CFR 117.80(c)Process Control Measures16
21 CFR 117.10Personnel15
21 CFR 211.22(d)Procedures not in writing, fully followed14

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 31, 2019Dianne's Fine DessertsFoodBrownie product contains undeclared peanuts
Dec 31, 2019Rachael's Food CorporationFoodProduct may be contaminated with Listeria monocytogenes.
Dec 30, 2019International Sprout Holding Inc.FoodPossible contamination with E. Coli.
Dec 30, 2019International Sprout Holding Inc.FoodPossible contamination with E. Coli.
Dec 30, 2019MeijerFoodPossible L. mono contamination in hard boiled eggs
Dec 27, 2019Cheesewich FactoryFoodEggs in RTE bacon and egg packet may contain Listeria Monocytogenes.
Dec 27, 2019Five Star Gourmet Foods Of FloridaFoodProducts have potential to be contaminated with Listeria monocytogenes.
Dec 27, 2019Five Star Gourmet Foods Of FloridaFoodProducts have potential to be contaminated with Listeria monocytogenes.
Dec 27, 2019Fresh Unlimited IncFoodEggs used in the manufacture of the products may be contaminated with Listeria monocytogenes
Dec 27, 2019Fresh Unlimited IncFoodEggs used in the manufacture of the products may be contaminated with Listeria monocytogenes
Dec 27, 2019Fresh Unlimited IncFoodEggs used in the manufacture of the products may be contaminated with Listeria monocytogenes
Dec 27, 2019RemedyRepack Inc.DrugsPresence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed…
Dec 27, 2019Sun Valley FoodsFoodPotential Listeria monocytogenes contamination in hard boiled eggs
Dec 27, 2019Sun Valley FoodsFoodPotential Listeria monocytogenes contamination in hard boiled eggs
Dec 26, 2019Veggie Noodle CoFoodPotential to be contaminated with Listeria monocytogenes
Dec 24, 2019Dierbergs Markets, Inc Corporate OfficeFoodThe firm received a recall notice for hardboiled eggs that were potentially contaminated with Listeria monocytogenes. The eggs were…
Dec 24, 2019Dierbergs Markets, Inc Corporate OfficeFoodThe firm received a recall notice for hardboiled eggs that were potentially contaminated with Listeria monocytogenes. The eggs were…
Dec 24, 2019Dierbergs Markets, Inc Corporate OfficeFoodThe firm received a recall notice for hardboiled eggs that were potentially contaminated with Listeria monocytogenes. The eggs were…
Dec 24, 2019Dierbergs Markets, Inc Corporate OfficeFoodThe firm received a recall notice for hardboiled eggs that were potentially contaminated with Listeria monocytogenes. The eggs were…
Dec 24, 2019Dierbergs Markets, Inc Corporate OfficeFoodThe firm received a recall notice for hardboiled eggs that were potentially contaminated with Listeria monocytogenes. The eggs were…
Dec 24, 2019Dierbergs Markets, Inc Corporate OfficeFoodThe firm received a recall notice for hardboiled eggs that were potentially contaminated with Listeria monocytogenes. The eggs were…
Dec 24, 2019Sprouts Unlimited IncFoodThe firm's sprout products are linked to an outbreak of E. coli O103 illness in Iowa.
Dec 24, 2019The H.T. Hackney Co. LLCFoodProduct potentially contaminated with Listeria monocytogenes.
Dec 24, 2019The H.T. Hackney Co. LLCFoodProduct potentially contaminated with Listeria monocytogenes.
Dec 23, 2019Great American Deli, LLCFoodAlmark Foods issued recall for potential Listeria monocytogenes in ingredient used by firm's supplier.
Dec 23, 2019Reichel Foods Inc.FoodProducts are being recalled due to Listeria monocytogenes contamination.
Dec 23, 2019Reichel Foods Inc.FoodProducts are being recalled due to Listeria monocytogenes contamination.
Dec 21, 2019Bakkavor Foods USA Inc.FoodThe firm was notified by their supplier of boiled eggs that the eggs my be contaminated with Listeria monocytogenes.
Dec 21, 2019Bakkavor Foods USA Inc.FoodThe firm was notified by their supplier of boiled eggs that the eggs my be contaminated with Listeria monocytogenes.
Dec 20, 2019EMESA FOODS COFoodproduct tested positive for salmonella
Dec 20, 2019Knotts Fine Foods IncFoodAlmark Foods issued recall for possible Listeria monocytogenes in eggs, which is an ingredient used in the production of egg salad.
Dec 20, 2019Knotts Fine Foods IncFoodAlmark Foods issued recall for possible Listeria monocytogenes in eggs, which is an ingredient used in the production of egg salad.
Dec 20, 2019Taro Pharmaceuticals U.S.A., Inc.DrugsCross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Almark Foods, LLCFoodThe firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and…
Dec 19, 2019Whole Foods MarketFoodPotential to contain undeclared milk.
Dec 19, 2019Whole Foods MarketFoodPotential to contain undeclared milk and coconut.
Dec 17, 2019Hikma Pharmaceuticals USA Inc.DrugsPresence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Dec 17, 2019Motto International CorpDrugsMarketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Dec 17, 2019Motto International CorpDrugsMarketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Dec 17, 2019Motto International CorpDrugsMarketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Dec 17, 2019Motto International CorpDrugsMarketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Dec 13, 2019TELEFLEX MEDICAL INCDevicesThere is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is…
Dec 13, 2019TELEFLEX MEDICAL INCDevicesThere is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is…
Dec 13, 2019TELEFLEX MEDICAL INCDevicesThere is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is…
Dec 13, 2019TELEFLEX MEDICAL INCDevicesThere is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is…
Dec 12, 2019ResMed Ltd.DevicesCombination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for…
Dec 10, 2019CATSMO LLCFoodProduct may be contaminated with Listeria monocytogenes.
Dec 10, 2019CATSMO LLCFoodProduct may be contaminated with Listeria monocytogenes.
Dec 10, 2019CATSMO LLCFoodProduct may be contaminated with Listeria monocytogenes.
Dec 10, 2019CATSMO LLCFoodProduct may be contaminated with Listeria monocytogenes.
Dec 10, 2019CATSMO LLCFoodProduct may be contaminated with Listeria monocytogenes.
Dec 10, 2019CATSMO LLCFoodProduct may be contaminated with Listeria monocytogenes.
Dec 10, 2019CATSMO LLCFoodProduct may be contaminated with Listeria monocytogenes.
Dec 10, 2019FIVE STAR FOOD INCFoodproduct samples positive for salmonella
Dec 6, 2019Gourmet International Ltd.Foodundeclared milk
Dec 6, 2019Lannett Company, Inc.DrugsMicrobial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
Dec 6, 2019Tailor Cut Produce Inc.FoodProducts have the potential to be contaminated with Salmonella.
Dec 6, 2019Tailor Cut Produce Inc.FoodProducts have the potential to be contaminated with Salmonella.
Dec 6, 2019Tailor Cut Produce Inc.FoodProducts have the potential to be contaminated with Salmonella.
Dec 6, 2019Tailor Cut Produce Inc.FoodProducts have the potential to be contaminated with Salmonella.
Dec 6, 2019Tailor Cut Produce Inc.FoodProducts have the potential to be contaminated with Salmonella.
Dec 6, 2019Tailor Cut Produce Inc.FoodProducts have the potential to be contaminated with Salmonella.
Dec 6, 2019Tailor Cut Produce Inc.FoodProducts have the potential to be contaminated with Salmonella.
Dec 4, 2019Argon Medical Devices, IncDevicesThe stiffness of the soft end of the guidewire caused tissue perforation.
Dec 4, 2019Argon Medical Devices, IncDevicesThe stiffness of the soft end of the guidewire caused tissue perforation.
Dec 3, 2019Lin's Waha International Corp.FoodProducts contain undeclared sulfites and cyclamates.
Dec 3, 2019Lin's Waha International Corp.FoodProducts contain undeclared sulfites and cyclamates.
Dec 3, 2019Mrs. Condies Salad Company, IncorporatedFoodRanch Dressing dip contains undeclared milk as an ingredient.
Dec 3, 2019Onset WorldwideFoodOnset Worldwide has initiated a recall of Nitro-Milled Black Chia, Unit size: 50 lb Bulk Kraft paper bags with blue plastic liner. Codes…
Dec 2, 2019Dole Fresh Vegetables IncFoodCanadian Food Inspection Agency reported finding Salmonella in a sample of Coleslaw with Green and Red Cabbage and Carrots.

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.