Home / Months / January 2019

FDA Warning Letters, 483s and Recalls: January 2019

FDA enforcement records dated January 2019: 0 warning letters outside tobacco, 13 OAI inspections and 122 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
Jan 31, 2019Mighty Vapors, LLCTobaccoUnited States
Jan 31, 2019V8P Juice International, LLCTobaccoUnited States
Jan 29, 2019Pharmacy Resources IncorporatedDrugsUnited States
Jan 28, 2019Pet Pharmacy NW LLCDrugsUnited States
Jan 25, 2019Lupin LimitedDrugsIndia
Jan 25, 2019Opto-Pharm Pte Ltd.DrugsSingapore
Jan 23, 2019Complete Pharmacy And Medical Solutions, LLC.DrugsUnited States
Jan 23, 2019Tris Pharma Inc.DrugsUnited States
Jan 22, 2019PT. Primo Indo IkanFood/CosmeticsIndonesia
Jan 18, 2019Deva Holding Anonim Sirketi - Cerkezkoy SubesiDrugsTurkey
Jan 11, 2019La Sonorense, Inc.Food/CosmeticsUnited States
Jan 10, 2019Comasphere LLCTobaccoUnited States
Jan 10, 2019Xi'an Livingbond Nonwoven Products Corp., Ltd.DrugsChina

Most-cited Form 483 sections

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

CFR sectionObservationCitations
21 CFR 123.6(b)No HACCP plan18
21 CFR 123.11(b)Sanitation monitoring documentation14
21 CFR 312.60Informed consent13
21 CFR 123.6(c)(1)Food safety hazards11
21 CFR 123.6(c)(2)Critical control points10
21 CFR 211.22(d)Procedures not in writing, fully followed9
21 CFR 117.10Personnel8
21 CFR 211.192Written record of investigation incomplete8
21 CFR 117.80(c)Process Control Measures7
21 CFR 117.130(a)(1)Hazard Analysis - Identification of Hazard6

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
Jan 25, 2019Natures RxDrugsMarketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Jan 25, 2019The Boston Smoked Fish Company LLCFoodLow water phase salt.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 24, 2019Whole Foods MarketFoodProduct potentially contaminated with Salmonella.
Jan 23, 2019Satur Farms LLCFoodProduct may be contaminated with Salmonella.
Jan 23, 2019Satur Farms LLCFoodProduct may be contaminated with Salmonella.
Jan 23, 2019THRIVE MARKETFoodPotential Listeria monocytogenes contamination.
Jan 23, 2019THRIVE MARKETFoodPotential Listeria monocytogenes contamination.
Jan 23, 2019THRIVE MARKETFoodPotential Listeria monocytogenes contamination.
Jan 23, 2019THRIVE MARKETFoodPotential Listeria monocytogenes contamination.
Jan 23, 2019THRIVE MARKETFoodPotential Listeria monocytogenes contamination.
Jan 23, 2019THRIVE MARKETFoodPotential Listeria monocytogenes contamination.
Jan 23, 2019THRIVE MARKETFoodPotential Listeria monocytogenes contamination.
Jan 23, 2019THRIVE MARKETFoodPotential Listeria monocytogenes contamination.
Jan 23, 2019THRIVE MARKETFoodPotential Listeria monocytogenes contamination.
Jan 23, 2019THRIVE MARKETFoodPotential Listeria monocytogenes contamination.
Jan 22, 2019Jac Vandenberg Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jan 22, 2019Jac Vandenberg Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jan 22, 2019Jac Vandenberg Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jan 17, 2019Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF)DevicesA subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta…
Jan 17, 2019Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF)DevicesA subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta…
Jan 17, 2019Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF)DevicesA subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta…
Jan 17, 2019Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF)DevicesA subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta…
Jan 17, 2019Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF)DevicesA subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta…
Jan 17, 2019Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF)DevicesA subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta…
Jan 17, 2019Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF)DevicesA subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta…
Jan 16, 2019Puratos CorporationFoodProduct contains undeclared milk.
Jan 15, 2019Ottogi America IncFoodUndeclared allergen; egg.
Jan 15, 2019Ottogi America IncFoodUndeclared allergen; egg.
Jan 15, 2019Ottogi America IncFoodUndeclared allergen; egg.
Jan 15, 2019Ottogi America IncFoodUndeclared allergen; egg.
Jan 15, 2019Ottogi America IncFoodUndeclared allergen; egg.
Jan 15, 2019Ottogi America IncFoodUndeclared allergen; egg.
Jan 15, 2019Ottogi America IncFoodUndeclared allergen; egg.
Jan 15, 2019Ottogi America IncFoodUndeclared allergen; egg.
Jan 15, 2019Ottogi America IncFoodUndeclared allergen; egg.
Jan 15, 2019Ottogi America IncFoodUndeclared allergen; egg.
Jan 15, 2019Ottogi America IncFoodUndeclared allergen; egg.
Jan 15, 2019Ottogi America IncFoodUndeclared allergen; egg.
Jan 15, 2019Ottogi America IncFoodUndeclared allergen; egg.
Jan 15, 2019Ottogi America IncFoodUndeclared allergen; egg.
Jan 15, 2019Ottogi America IncFoodUndeclared allergen; egg.
Jan 15, 2019Ottogi America IncFoodUndeclared allergen; egg.
Jan 15, 2019Ottogi America IncFoodUndeclared allergen; egg.
Jan 11, 2019McCormick & Company, Inc. - Flavor Manufacturing CenterFoodMojave Foods Corporation (subsidiary of McCormick) is initiating a voluntary recall of El Guapo Chile Habanero and Chili Pasilla-Ancho…
Jan 11, 2019McCormick & Company, Inc. - Flavor Manufacturing CenterFoodMojave Foods Corporation (subsidiary of McCormick) is initiating a voluntary recall of El Guapo Chile Habanero and Chile Pasilla-Ancho…
Jan 8, 2019Happy Together, Inc.DrugsMarketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Jan 8, 2019Winter Gardens Quality Foods, Inc.FoodProducts potentially contaminated with Salmonella.
Jan 7, 2019Pizza Blends, LLCFoodThe firm received an ingredient from their supplier that is potentially contaminated with Salmonella.
Jan 7, 2019Pizza Blends, LLCFoodThe firm received an ingredient from their supplier that is potentially contaminated with Salmonella.
Jan 7, 2019Pizza Blends, LLCFoodThe firm received an ingredient from their supplier that is potentially contaminated with Salmonella.
Jan 7, 2019Pizza Blends, LLCFoodThe firm received an ingredient from their supplier that is potentially contaminated with Salmonella.
Jan 7, 2019Pizza Blends, LLCFoodThe firm received an ingredient from their supplier that is potentially contaminated with Salmonella.
Jan 7, 2019Pizza Blends, LLCFoodThe firm received an ingredient from their supplier that is potentially contaminated with Salmonella.
Jan 7, 2019Pizza Blends, LLCFoodThe firm received an ingredient from their supplier that is potentially contaminated with Salmonella.
Jan 7, 2019Pizza Blends, LLCFoodThe firm received an ingredient from their supplier that is potentially contaminated with Salmonella.
Jan 7, 2019Pizza Blends, LLCFoodThe firm received an ingredient from their supplier that is potentially contaminated with Salmonella.
Jan 7, 2019Pizza Blends, LLCFoodThe firm received an ingredient from their supplier that is potentially contaminated with Salmonella.
Jan 4, 2019Diamond Crystal Brands, Inc.FoodRecalled products were manufactured with an ingredient that is potentially contaminated with Salmonella.
Jan 4, 2019Diamond Crystal Brands, Inc.FoodRecalled products were manufactured with an ingredient that is potentially contaminated with Salmonella.
Jan 4, 2019Diamond Crystal Brands, Inc.FoodRecalled products were manufactured with an ingredient that is potentially contaminated with Salmonella.
Jan 4, 2019Diamond Crystal Brands, Inc.FoodRecalled products were manufactured with an ingredient that is potentially contaminated with Salmonella.
Jan 4, 2019Diamond Crystal Brands, Inc.FoodRecalled products were manufactured with an ingredient that is potentially contaminated with Salmonella.
Jan 4, 2019Diamond Crystal Brands, Inc.FoodRecalled products were manufactured with an ingredient that is potentially contaminated with Salmonella.
Jan 4, 2019Diamond Crystal Brands, Inc.FoodRecalled products were manufactured with an ingredient that is potentially contaminated with Salmonella.
Jan 4, 2019Diamond Crystal Brands, Inc.FoodRecalled products were manufactured with an ingredient that is potentially contaminated with Salmonella.
Jan 4, 2019Diamond Crystal Brands, Inc.FoodRecalled products were manufactured with an ingredient that is potentially contaminated with Salmonella.
Jan 4, 2019Diamond Crystal Brands, Inc.FoodRecalled products were manufactured with an ingredient that is potentially contaminated with Salmonella.

Showing the latest 100 of 122.

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.