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FDA Warning Letters, 483s and Recalls: November 2018

FDA enforcement records dated November 2018: 0 warning letters outside tobacco, 36 OAI inspections and 41 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
Nov 30, 2018Cord For Life, Inc.BiologicsUnited States
Nov 30, 2018Lone Palm, Inc.Food/CosmeticsUnited States
Nov 30, 2018Pescaderia CatanoFood/CosmeticsUnited States
Nov 30, 2018SnugZ USA, Inc.DrugsUnited States
Nov 29, 2018Orangeburg Pecan Company IncFood/CosmeticsUnited States
Nov 28, 2018Chukar Cherry CompanyFood/CosmeticsUnited States
Nov 28, 2018The Fierro Group Inc.Food/CosmeticsUnited States
Nov 26, 2018Still Water Dairy, LLCVeterinaryUnited States
Nov 21, 2018Whitsons Food Service (Bronx), LLCFood/CosmeticsUnited States
Nov 16, 2018A6 Supplements, Inc.Food/CosmeticsUnited States
Nov 16, 2018ABH Nature's Products, Inc.Food/CosmeticsUnited States
Nov 16, 2018McDaniel Life-Line LLCDrugsUnited States
Nov 16, 2018Spectrum Laboratory Products, Inc.DrugsUnited States
Nov 15, 20185000 Years Foods, Inc.Food/CosmeticsUnited States
Nov 15, 2018Desert Premium Group LLCFood/CosmeticsUnited States
Nov 15, 2018Merchants Market St. Croix LLCFood/CosmeticsUnited States
Nov 14, 2018Duren Health Mart PharmacyDrugsUnited States
Nov 13, 2018Advanced Botanical Consulting & Testing, LLCDrugsUnited States
Nov 9, 2018Bedessee Imports, IncFood/CosmeticsUnited States
Nov 9, 2018Carolina Liquid Chemistries CorpDevicesUnited States
Nov 9, 2018Rechargeable Power Energy North America LLCDevicesUnited States
Nov 9, 2018Secret Garden Of Health & Healing, LLCFood/CosmeticsUnited States
Nov 9, 2018Zeller Power Products, LLCDevicesUnited States
Nov 8, 2018DeGrave DairyVeterinaryUnited States
Nov 8, 2018WEBER MEDICAL GMBHDevicesGermany
Nov 7, 2018Davis Ventures, Inc.Food/CosmeticsUnited States
Nov 7, 2018Kadesh InternationalDrugsUnited States
Nov 7, 2018Natural Energy Products, Inc.Food/CosmeticsUnited States
Nov 6, 2018Bowles Packaging Co., Inc.Food/CosmeticsUnited States
Nov 5, 2018Fill It Pack It IncDrugsUnited States
Nov 2, 2018BioV Health Inc.DrugsCanada
Nov 2, 2018TEI Biosciences, Inc.DevicesUnited States
Nov 1, 2018Contacare Ophthalmics & DiagnosticsDrugsIndia
Nov 1, 2018Med Shop Total Care Inc.DrugsUnited States
Nov 1, 2018Scenic View Dairy, LLCVeterinaryUnited States
Nov 1, 2018We Pack It All LLCDrugsUnited States

Most-cited Form 483 sections

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

CFR sectionObservationCitations
21 CFR 117.35(a)Sanitary operations - Plant sanitation36
21 CFR 1.502(a)Maintain, follow FSVP30
21 CFR 123.6(b)No HACCP plan26
21 CFR 820.198(a)Lack of or inadequate complaint procedures23
21 CFR 820.100(a)Lack of or inadequate procedures22
21 CFR 123.11(b)Sanitation monitoring documentation19
21 CFR 117.10Personnel18
21 CFR 117.35(c)Pest control16
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures15
FDCA 402(a)(4)System for administration of drugs15

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
Nov 30, 2018K & T Oriental Imports Inc.FoodPotential to be contaminated with Listeria monocytogenes
Nov 29, 2018Advanced Pharma Inc.DrugsLabeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration…
Nov 27, 2018Kwik Trip, Inc.FoodKitchen Cravings Strawberry and Mixed Berry Parfaits in an 8.25 oz. cup may contain undeclared traces of tree nuts(specifically almond and…
Nov 27, 2018Kwik Trip, Inc.FoodKitchen Cravings Strawberry and Mixed Berry Parfaits in an 8.25 oz. cup may contain undeclared traces of tree nuts(specifically almond and…
Nov 27, 2018Oakhouse BakeryFoodBulk Granola may contain undeclared tree nuts (specifically cashew and almond)
Nov 27, 2018Sprout Creek Farm, Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Nov 26, 2018Soom FoodsFoodSoom Foods is recalling its tahini and chocolate tahini halva spread because their manufacturer, Achdut LTD. is recalling its Tahini…
Nov 26, 2018Soom FoodsFoodSoom Foods is recalling its tahini and chocolate tahini halva spread because their manufacturer, Achdut LTD. is recalling its Tahini…
Nov 24, 2018TRES HERMANOS BAKERYFoodTres Hermanos Bakery initiated a voluntary recall of Telera and Bolillo due to undeclared allergen milk.
Nov 23, 2018AchdutFoodProduct may be contaminated with Salmonella.
Nov 23, 2018AchdutFoodProduct may be contaminated with Salmonella.
Nov 23, 2018AchdutFoodProduct may be contaminated with Salmonella.
Nov 23, 2018AchdutFoodProduct may be contaminated with Salmonella.
Nov 21, 2018Ottogi America IncFoodUndeclared allergen; egg.
Nov 21, 2018Ottogi America IncFoodUndeclared allergen; egg.
Nov 16, 2018Agropur MSI Ingredients LLCFoodJayRobb Unflavored Egg White Protein Product is being recalled due to undeclared milk.
Nov 16, 2018Chukar Cherry CompanyFoodProduct contains unintentional presence of milk and therefore milk was not listed on the label as an ingredient.
Nov 16, 2018Chukar Cherry CompanyFoodProduct contains unintentional presence of milk and therefore milk was not listed on the label as an ingredient.
Nov 16, 2018Chukar Cherry CompanyFoodProduct contains unintentional presence of milk and therefore milk was not listed on the label as an ingredient.
Nov 16, 2018Chukar Cherry CompanyFoodProduct contains unintentional presence of milk and therefore milk was not listed on the label as an ingredient.
Nov 16, 2018Chukar Cherry CompanyFoodProduct contains unintentional presence of milk and therefore milk was not listed on the label as an ingredient.
Nov 16, 2018Marich Confectionery Company, Inc.FoodFirm was notified by a direct customer that milk chocolate macadamia nuts were found in their shipment of milk chocolate maltballs.
Nov 15, 2018Fresenius Kabi USA, LLCDrugsLabeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product…
Nov 15, 2018Fresenius Kabi USA, LLCDrugsLabeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product…
Nov 14, 2018Harb Dairy, Inc. DBA Green Cedar DairyFoodHarb Dairy dba Green Cedar Dairy initiated a voluntary recall of Ackawi cheese following notification by U.S. Food and Drug Administration…
Nov 13, 2018Nor Cal Food Solutions LLCFoodPumpkin Pesto does not declare walnuts as ingredient or allergen.
Nov 13, 2018Quaker Manufacturing, LLCFoodProduct tested positive for Salmonella.
Nov 13, 2018RVO 2.0, INCDevicesDuring a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.
Nov 9, 2018ALEBRIJE IMPORTS INCFoodCalifornia Department of Food and Agriculture sampled and found Salmonella in cheese imported from Mexico.
Nov 9, 2018Confections By Michael RecchiutiFoodFDA analysis of Dairy Free Dark Chocolate found high levels of milk protein in the chocolate bars.
Nov 9, 2018Confections By Michael RecchiutiFoodFDA analysis of Dairy Free Dark Chocolate found high levels of milk protein in the chocolate bars
Nov 9, 2018Country Favor Inc.FoodProduct contains undeclared sulfites (75 mg per serving).
Nov 7, 2018Wegmans Food Markets, Inc.FoodProduct contains undeclared milk.
Nov 7, 2018Wegmans Food Markets, Inc.FoodProduct contains undeclared milk.
Nov 6, 2018NEW FOREST LLCFoodProduct may be contaminated with Salmonella.
Nov 6, 2018Sprout Creek Farm, Inc.FoodProduct is contaminated with Listeria monocytogenes.
Nov 6, 2018Ukrop's Homestyle Foods, LLCFoodMislabeling and Undeclared allergens: Baked Potatoes with Cheddar Cheese & Bacon were mislabeled as Herb Roasted Potatoes.
Nov 5, 2018Bakkavor Foods USA Inc.FoodProduct contains Lobster, Shrimp, and Soy which are not included on the label.
Nov 5, 2018Kadesh InternationalDrugsNon-Sterility: Product manufactured under non-sterile production conditions.
Nov 2, 2018Frito-Lay, Inc.FoodThe firm is recalling 1/2 oz. bags of Smartfood Delight Sea Salt Flavored popcorn packaged in two variety pack offerings. The popcorn bags…
Nov 2, 2018Frito-Lay, Inc.FoodThe firm is recalling 1/2 oz. bags of Smartfood Delight Sea Salt Flavored popcorn packaged in two variety pack offerings. The popcorn bags…

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.