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FDA Warning Letters, 483s and Recalls: January 2018

FDA enforcement records dated January 2018: 0 warning letters outside tobacco, 24 OAI inspections and 47 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, 2018Bellingham IVF & Fertility CareBiologicsUnited States
Jan 30, 2018Ng Zheng IncFood/CosmeticsUnited States
Jan 29, 2018WAVi Co.DevicesUnited States
Jan 26, 2018Infusion Partners, LLCDrugsUnited States
Jan 26, 2018Kashiv BioSciences, LLCDrugsUnited States
Jan 26, 2018Peak Nootropics, LLCFood/CosmeticsUnited States
Jan 26, 2018StemGenex Biologic Laboratories, LLCBiologicsUnited States
Jan 26, 2018Techni Med, Inc.DrugsUnited States
Jan 26, 2018The Health Management Group Inc.Food/CosmeticsUnited States
Jan 25, 2018Arrow Reliance IncVeterinaryUnited States
Jan 23, 2018Southern Coast EnterprisesFood/CosmeticsUnited States
Jan 19, 2018Davis Ventures, Inc.Food/CosmeticsUnited States
Jan 19, 2018Dona Newtower Natural Drink And Food Joint Stock CompanyFood/CosmeticsVietnam
Jan 19, 2018GC NaturalFood/CosmeticsUnited States
Jan 19, 2018Indoco Remedies Limited (Plant I)DrugsIndia
Jan 17, 2018College Pharmacy, Inc.DrugsUnited States
Jan 16, 2018The Fierro Group Inc.Food/CosmeticsUnited States
Jan 12, 2018MBi Distributing Inc.DrugsUnited States
Jan 11, 2018Anna's Pies, LLCFood/CosmeticsUnited States
Jan 11, 2018Bimeda Pomona Inc.VeterinaryUnited States
Jan 10, 2018Flawless Beauty And SkinDrugsUnited States
Jan 10, 2018Foo Yuan Food ProductsFood/CosmeticsUnited States
Jan 8, 2018Original Living Coconut LLCFood/CosmeticsUnited States
Jan 5, 2018PharMEDium Services, LLC.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 820.100(a)Lack of or inadequate procedures22
21 CFR 820.198(a)Lack of or inadequate complaint procedures20
21 CFR 117.35(a)Sanitary operations - Plant sanitation19
21 CFR 110.35(a)Cleaning and sanitizing operations18
21 CFR 1.502(a)Develop FSVP18
FDCA 402(a)(4)System for administration of drugs18
FDCA 501(a)(2)(A)Personnel habits, contamination17
21 CFR 117.80(c)Manufacturing, processing, packing, holding - Controls15
21 CFR 110.20(b)(4)Floors, walls and ceilings14
21 CFR 123.11(b)Sanitation monitoring documentation14

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 26, 2018bioMerieux, Inc.DevicesCustomer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.
Jan 26, 2018Primus Pharmaceuticals, Inc.DrugsMarketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy…
Jan 26, 2018Primus Pharmaceuticals, Inc.DrugsMarketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy…
Jan 26, 2018Primus Pharmaceuticals, Inc.DrugsMarketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy…
Jan 26, 2018Primus Pharmaceuticals, Inc.DrugsMarketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy…
Jan 24, 2018Panera, LLCFoodProduct may be contaminated with Listeria monocytogenes.
Jan 24, 2018Panera, LLCFoodProduct may be contaminated with Listeria monocytogenes.
Jan 24, 2018Panera, LLCFoodProduct may be contaminated with Listeria monocytogenes.
Jan 24, 2018Panera, LLCFoodProduct may be contaminated with Listeria monocytogenes.
Jan 24, 2018Panera, LLCFoodProduct may be contaminated with Listeria monocytogenes.
Jan 23, 2018Bulletproof 360 IncFoodBulletproof Collagen Protein is recalled due to undeclared milk. The actual product inside the package is whey (milk) protein but…
Jan 22, 2018Mountain Rose IncFoodPrickly Ash Bark Powder is recalled due to a potential contamination with Salmonella.
Jan 20, 2018ABH Nature's Products, Inc.FoodProduct may be contaminated with Salmonella.
Jan 20, 2018ABH Nature's Products, Inc.FoodProduct may be contaminated with Salmonella.
Jan 17, 2018Magno Humphries Laboratories, IncDrugsLabeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative contained only tablets of Naproxen Sodium 220…
Jan 16, 2018Frog Holler Ltd.FoodFrog Holler Produce initiated a voluntary recall of cherry tomatoes, packaged in a pint sized plastic clamshell due to potential…
Jan 16, 2018Ottogi America IncFoodFirm determined that their Rice Cake Soup has undeclared milk in the form of sodium caseinate.
Jan 12, 2018AuroMedics Pharma LLCDrugsPresence of Particulate Matter; contains visible particulate matter identified as mold.
Jan 12, 2018Beckman Coulter Inc.DevicesA manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of…
Jan 12, 2018Beckman Coulter Inc.DevicesA manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of…
Jan 12, 2018The Compounding Pharmacy Of AmericaDrugsNon-Sterility
Jan 11, 2018Hiland Dairy Foods Company LLCFoodMilk allergen was detected in one lot of orange juice and one lot of citrus drink. Milk is not an ingredient declared on the label.
Jan 11, 2018Hiland Dairy Foods Company LLCFoodMilk allergen was detected in one lot of orange juice and one lot of citrus drink. Milk is not an ingredient declared on the label.
Jan 8, 2018Gilster-Mary Lee Corp.FoodA consumer purchased who purchased a labeled Coat & Bake Chicken but actually contained Pork Seasoning. The Pork Seasoning product contains…
Jan 5, 2018Advanced Pharma Inc.DrugsSubpotent
Jan 5, 2018H.I.G. CorporationFoodCustomer tested product and found Listeria monocytogenes in frozen tuna fillet saku
Jan 4, 2018Dollar General Corporation, Inc.FoodThe firm received Ice Oatmeal Cookies that actually contain Coconut Macaroon Cookies. Product is being recalled due to mislabeling…
Jan 4, 2018International Laboratories, LLCDrugsLABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
Jan 3, 2018Fieldbrook Foods CorporationFoodProduct may be contaminated with Listeria monocytogenes.
Jan 3, 2018Fieldbrook Foods CorporationFoodProduct may be contaminated with Listeria monocytogenes.
Jan 3, 2018Fieldbrook Foods CorporationFoodProduct may be contaminated with Listeria monocytogenes.
Jan 3, 2018Fieldbrook Foods CorporationFoodProduct may be contaminated with Listeria monocytogenes.
Jan 2, 2018Aurobindo Pharma Ltd.DrugsPresence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as…
Jan 2, 2018Condies Foods, Inc.FoodCondies Foods is recalling Veggie Cups due to undeclared milk and egg.
Jan 2, 2018Evershing International Trading Inc.FoodState of Massachusetts tested product and found it to be positive for Salmonella
Jan 2, 2018Productos Pacheco, Inc.FoodUndeclared allergens: wheat, soy, Yellow # 5, Yellow # 6, Red # 40, and potassium sorbate.
Jan 2, 2018Productos Pacheco, Inc.FoodUndeclared allergens: wheat, soy, eggs, and milk.
Jan 2, 2018Productos Pacheco, Inc.FoodUndeclared allergens: wheat and milk.
Jan 2, 2018Productos Pacheco, Inc.FoodUndeclared allergens: soy.
Jan 2, 2018Productos Pacheco, Inc.FoodUndeclared allergens: wheat, soy, and milk.
Jan 2, 2018Productos Pacheco, Inc.FoodUndeclared allergens: wheat, soy, milk, Yellow # 5, and Yellow # 6.
Jan 2, 2018Productos Pacheco, Inc.FoodUndeclared allergens: wheat, soy, milk, Red # 40, and potassium sorbate.
Jan 2, 2018Productos Pacheco, Inc.FoodUndeclared allergens: soy and wheat.
Jan 2, 2018Productos Pacheco, Inc.FoodUndeclared allergens: soy, potassium sorbate.
Jan 2, 2018Productos Pacheco, Inc.FoodUndeclared allergens: soy.
Jan 2, 2018Productos Pacheco, Inc.FoodUndeclared allergens: soy
Jan 2, 2018Productos Pacheco, Inc.FoodUndeclared allergens: wheat, soy, and egg.

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.