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FDA Warning Letters, 483s and Recalls: February 2018

FDA enforcement records dated February 2018: 0 warning letters outside tobacco, 26 OAI inspections and 32 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
Feb 28, 2018JT Cosmetics & Chemicals Pvt Ltd.DrugsIndia
Feb 28, 2018N-Molecular Inc. D.B.A. SOFIEDrugsUnited States
Feb 27, 2018BioDiagnostic InternationalDrugsUnited States
Feb 27, 2018TYRX Inc.DevicesUnited States
Feb 24, 2018Vipor Chemicals Private Ltd.DrugsIndia
Feb 23, 2018Norax Supplements LLCFood/CosmeticsUnited States
Feb 23, 2018Nutrafill, LLCFood/CosmeticsUnited States
Feb 22, 2018Cochlear Americas Inc.DevicesUnited States
Feb 21, 2018ECRS, LLCFood/CosmeticsUnited States
Feb 14, 2018Jodi Lynn's, Inc.Food/CosmeticsUnited States
Feb 14, 2018Tufos To Go LLCFood/CosmeticsUnited States
Feb 13, 2018ABH Nature's Products, Inc.Food/CosmeticsUnited States
Feb 13, 2018Starlight Desserts IncFood/CosmeticsUnited States
Feb 9, 2018Samson Pharmaceuticals, IncDrugsUnited States
Feb 9, 2018Vista Pharmaceuticals LimitedDrugsIndia
Feb 7, 2018Flying Food Group, LLCFood/CosmeticsUnited States
Feb 7, 2018Lone Palm, Inc.Food/CosmeticsUnited States
Feb 6, 2018Elwood International, Inc.Food/CosmeticsUnited States
Feb 6, 2018Hanlim Pharm Co. Ltd.DrugsKorea (the Republic of)
Feb 2, 2018HoneyCombs Industries, LLCFood/CosmeticsUnited States
Feb 2, 2018MWM Ministries, LLCFood/CosmeticsUnited States
Feb 2, 2018Thrive And Revive MinistiresFood/CosmeticsUnited States
Feb 2, 2018Thrive And Revive MinistiresFood/CosmeticsUnited States
Feb 1, 2018Blue Heron Community CooperativeFood/CosmeticsUnited States
Feb 1, 2018Fortune Food Product, Inc.Food/CosmeticsUnited States
Feb 1, 2018Schmidt, JamesVeterinaryUnited 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 procedures26
21 CFR 123.6(b)No HACCP plan25
21 CFR 123.11(b)Sanitation monitoring documentation23
21 CFR 820.198(a)Lack of or inadequate complaint procedures23
21 CFR 117.35(a)Sanitary operations - Plant sanitation22
21 CFR 117.40Equipment and utensils - Design and maintenance21
FDCA 402(a)(4)System for administration of drugs20
21 CFR 117.10Personnel16
21 CFR 117.37Sanitary facilities and controls16
21 CFR 1.502(a)Develop FSVP16

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
Feb 28, 2018Blue Moose Of Boulder, LLCFoodFirm is recalling Nut-Free Basil Pesto due to mislabeling, causing undeclared tree nuts.
Feb 26, 2018Micro Therapeutics Inc, Dba Ev3 NeurovascularDevicesThere is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire.
Feb 23, 2018Progressive Laboratories, IncFoodRecalled dietary supplements may contain undeclared milk.
Feb 23, 2018Progressive Laboratories, IncFoodRecalled dietary supplements may contain undeclared milk.
Feb 23, 2018Progressive Laboratories, IncFoodRecalled dietary supplements may contain undeclared milk.
Feb 23, 2018Progressive Laboratories, IncFoodRecalled dietary supplements may contain undeclared milk.
Feb 21, 2018La Pasta, Inc.FoodLA PASTA, INC has initiated a recall of Heinen's Potato Gnocchi 9 oz. , because of a undeclared milk allergen .
Feb 21, 2018Sunneen Health Foods, LLCFoodThe firm is recalling the products listed below because it is mislabeled. Products labeled as Vegan Buffalo Chicken Bites are in fact Vegan…
Feb 20, 2018Lotte International America Corp.FoodFirm was notified by customer of peanut allergen found in the product during product sampling and testing in Kancho Choco Biscuits.
Feb 20, 2018Market Of Choice IncFoodSezam Kale Salad kits, 6.43 lbs, are recalled due to undeclared egg. The wrong dressing packet was added to the Sezam Kale Salad kit and…
Feb 19, 2018Zimmer Biomet, Inc.DevicesLack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
Feb 19, 2018Zimmer Biomet, Inc.DevicesLack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
Feb 15, 2018Seggiano Usa Inc.FoodThe Tuscan Kale Pesto was mislabeled as Seggiano Artichoke & Garlic Sauce & Spread and therefore, contains undeclared cashews.
Feb 14, 2018Bella All NaturalDrugsMarketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence of sibutramine, a previously approved…
Feb 8, 2018WEIS MARKETSFoodPenne W/Asiago Sauce and Grilled Chix Small Meal is recalled due to undeclared milk.
Feb 7, 2018Pfizer Inc.DrugsNon-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Feb 7, 2018Pfizer Inc.DrugsNon-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Feb 6, 2018WEIS MARKETSFoodLabel does not list sub-ingredients for mayo and sour cream The product contains undeclared egg, milk.
Feb 5, 2018eBarsFoodThe product test positive for peanut allergen which is not declared on the product label.
Feb 5, 2018eBarsFoodThe product test positive for peanut allergen which is not declared on the product label.
Feb 5, 2018eBarsFoodThe product test positive for almond allergen which is not declared on the product label.
Feb 5, 2018eBarsFoodThe product test positive for peanut allergen which is not declared on the product label.
Feb 5, 2018eBarsFoodThe firm was notified by the State of TN that the product contained undeclared peanuts.
Feb 5, 2018eBarsFoodThe product test positive for peanut allergen which is not declared on the product label.
Feb 5, 2018eBarsFoodThe firm was notified by the State of TN that the product contained undeclared almonds.
Feb 5, 2018eBarsFoodThe firm was notified by the State of TN that the product contained undeclared almonds.
Feb 5, 2018eBarsFoodThe product test positive for peanut allergen which is not declared on the product label.
Feb 5, 2018eBarsFoodThe product test positive for peanut allergen which is not declared on the product label.
Feb 5, 2018eBarsFoodThe product test positive for peanut allergen which is not declared on the product label.
Feb 5, 2018eBarsFoodThe product test positive for peanut allergen which is not declared on the product label.
Feb 5, 2018eBarsFoodThe product test positive for peanuts and almond allergen which is not declared on the product label.
Feb 1, 2018J F C International IncFoodDaisho Kimchi Hot Pot Soup base contains undeclared fish - shrimp and crab.

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.