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FDA Warning Letters, 483s and Recalls: October 2018

FDA enforcement records dated October 2018: 0 warning letters outside tobacco, 31 OAI inspections and 50 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
Oct 30, 2018B & B Pharmaceuticals, Inc.DrugsUnited States
Oct 30, 2018SC Johnson Professional USA, Inc.DrugsUnited States
Oct 30, 2018U.S. Continental Marketing, Inc.DrugsUnited States
Oct 29, 2018Sparhawk Laboratories, Inc.VeterinaryUnited States
Oct 26, 2018Centurion Laboratories Private LimitedDrugsIndia
Oct 26, 2018MBBR International, IncFood/CosmeticsUnited States
Oct 26, 2018PRL IncFood/CosmeticsUnited States
Oct 26, 2018Zhongshan Baitian Photoelectric Technology Co. Ltd.DevicesChina
Oct 25, 2018Greiner Bio-One GmbHDevicesAustria
Oct 25, 2018Nurse Assist, LLCDevicesUnited States
Oct 25, 2018Promise Pharmacy, LLCDrugsUnited States
Oct 24, 2018Jus Bar LLCFood/CosmeticsUnited States
Oct 24, 2018Natural Solutions FoundationFood/CosmeticsUnited States
Oct 24, 2018Perfect Choice Trading, Inc.Food/CosmeticsUnited States
Oct 24, 2018TMC Acquisitions LLCDrugsUnited States
Oct 23, 2018Judge Farms IncFood/CosmeticsUnited States
Oct 23, 2018JW Closeout, LLC (Formerly J And L Grocery, LLC)DrugsUnited States
Oct 22, 2018Charanga Catering, LLCFood/CosmeticsUnited States
Oct 19, 2018Alchymars ICM SM Private LimitedDrugsIndia
Oct 19, 2018Central Soyfoods LLCFood/CosmeticsUnited States
Oct 19, 2018Livzon Group (Ningxia) Pharmaceutical Co., Ltd.DrugsChina
Oct 18, 2018Nutra Solutions USA, Inc.Food/CosmeticsUnited States
Oct 17, 2018JBS Souderton, Inc.VeterinaryUnited States
Oct 17, 2018Morningstar Minerals LLCFood/CosmeticsUnited States
Oct 12, 2018Sugar Daddy, LTDFood/CosmeticsUnited States
Oct 12, 2018Sunnyside OrchardFood/CosmeticsUnited States
Oct 11, 2018D & M Smoked Fish, Inc.Food/CosmeticsUnited States
Oct 11, 2018Red Mountain IncDrugsUnited States
Oct 9, 2018Starlight Desserts IncFood/CosmeticsUnited States
Oct 3, 2018Datascope Corp.DevicesUnited States
Oct 2, 2018American Contract SystemsDevicesUnited 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 procedures20
FDCA 402(a)(4)System for administration of drugs20
21 CFR 117.10Personnel19
21 CFR 117.35(c)Pest control19
21 CFR 117.35(a)Sanitary operations - Plant sanitation18
21 CFR 117.80(c)Manufacturing, processing, packing, holding - Controls17
21 CFR 123.11(b)Sanitation monitoring documentation16
21 CFR 820.198(a)Lack of or inadequate complaint procedures16
21 CFR 117.20(b)Plant construction and design15
21 CFR 123.6(b)No HACCP plan13

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
Oct 26, 2018Dr. Reddy's Laboratories, Inc.DrugsLabeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product…
Oct 26, 2018Maribel's Sweets, Inc.FoodProduct contains undeclared milk.
Oct 26, 2018Maribel's Sweets, Inc.FoodProduct contains undeclared milk.
Oct 26, 2018Maribel's Sweets, Inc.FoodProduct contains undeclared milk.
Oct 25, 2018Barcelona Nut CompanyFoodBarcelona Nut Company has initiated a recall of Roasted and Salted Select In shell Pistachios 21/25, flexible package, shelf life of one…
Oct 25, 2018Maquet Cardiovascular Us Sales, LlcDevicesThere is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in…
Oct 25, 2018Maquet Cardiovascular Us Sales, LlcDevicesThere is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in…
Oct 23, 2018AMI NewcoFoodNotified by immediate customer of Salmonella found in organic green whole cardamom pods.
Oct 23, 2018ARO Pistachios, Inc.FoodFirm is recalling one lot of pistachios after customer tested product and had a positive result for Salmonella
Oct 23, 2018Sam Dry Fruits And Enterprises Inc.FoodPositive result for Salmonella received while investigating to determine supplier of direct customer's positive findings also for Salmonella
Oct 23, 2018Sirob Imports, Inc.FoodProducts may contain elevated levels of lead.
Oct 23, 2018Sirob Imports, Inc.FoodProducts may contain elevated levels of lead.
Oct 19, 2018U.B.C. Food Distributors INC.FoodUBC FOOD Distributors initiated a voluntary recall of Baraka Hot and Mild Curry Powder packed in 7 oz. plastic tubs due to high levels of…
Oct 19, 2018U.B.C. Food Distributors INC.FoodUBC FOOD Distributors initiated a voluntary recall of Baraka Hot and Mild Curry Powder packed in 7 oz. plastic tubs due to high levels of…
Oct 17, 2018Cedar's Mediterranean Foods, Inc.FoodProduct may contain undeclared edamame (soy).
Oct 17, 2018Stewart's Shops Corp.FoodProduct contains undeclared milk.
Oct 14, 2018Fred Meyer Inc.FoodAngel Food Cake Bar was recalled due to undeclared milk and soy. The actual product inside container is corn breads and it was mislabeled…
Oct 11, 2018Feel Good Foods IncFoodProduct contains undeclared egg.
Oct 10, 2018Fine Land CorpFoodProduct contains undeclared milk.
Oct 10, 2018P. East Trading Corp.FoodProduct contains undeclared sulfites.
Oct 10, 2018SLR FOOD Distribution, Inc.FoodProduct contains undeclared sulfites.
Oct 9, 2018Synaptive Medical IncDevicesThis recall has been initiated due to a software defect found in the Guide System software when used with NICO BrainPath ports under…
Oct 8, 2018Kemps, LLCFoodSweet Me Creamery Brookie Dough ice cream may contain undeclared peanuts.
Oct 6, 2018Bazzini LLCFoodThe product tested positive for Salmonella.
Oct 6, 2018Bazzini LLCFoodThe product tested positive for Salmonella.
Oct 6, 2018Bazzini LLCFoodThe product tested positive for Salmonella.
Oct 6, 2018Bazzini LLCFoodThe product tested positive for Salmonella.
Oct 6, 2018Bazzini LLCFoodThe product tested positive for Salmonella.
Oct 5, 2018GE Healthcare, LLCDevicesThe ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. As a result, this could create a loss of…
Oct 5, 2018Ladyfingers Catering, LLCFoodThe firm was notified by their vendor that the product may be contaminated with Listeria monocytogenes.
Oct 4, 2018Callie's Charleston BiscuitsFoodThe firm was notified by one of their vendors that the ham used in their product may be contaminated with Listeria monocytogenes
Oct 4, 2018Callie's Charleston BiscuitsFoodThe firm was notified by one of their vendors that the ham used in their product may be contaminated with Listeria monocytogenes
Oct 4, 2018Ukrop's Homestyle Foods, LLCFoodThe products may have come into contact with equipment used to process the country ham the supplier recalled for Listeria monocytogenes.
Oct 4, 2018Ukrop's Homestyle Foods, LLCFoodThe products may have come into contact with equipment used to process the country ham the supplier recalled for Listeria monocytogenes.
Oct 4, 2018Ukrop's Homestyle Foods, LLCFoodThe products may have come into contact with equipment used to process the country ham the supplier recalled for Listeria monocytogenes.
Oct 4, 2018Ukrop's Homestyle Foods, LLCFoodThe products may have come into contact with equipment used to process the country ham the supplier recalled for Listeria monocytogenes.
Oct 4, 2018Ukrop's Homestyle Foods, LLCFoodThe products may have come into contact with equipment used to process the country ham the supplier recalled for Listeria monocytogenes.
Oct 4, 2018Ukrop's Homestyle Foods, LLCFoodThe products may have come into contact with equipment used to process the country ham the supplier recalled for Listeria monocytogenes.
Oct 4, 2018Ukrop's Homestyle Foods, LLCFoodThe products may have come into contact with equipment used to process the country ham the supplier recalled for Listeria monocytogenes.
Oct 4, 2018Ukrop's Homestyle Foods, LLCFoodThe products may have come into contact with equipment used to process the country ham the supplier recalled for Listeria monocytogenes.
Oct 4, 2018Ukrop's Homestyle Foods, LLCFoodThe products may have come into contact with equipment used to process the country ham the supplier recalled for Listeria monocytogenes.
Oct 4, 2018Ukrop's Homestyle Foods, LLCFoodThe products may have come into contact with equipment used to process the country ham the supplier recalled for Listeria monocytogenes.
Oct 4, 2018Ukrop's Homestyle Foods, LLCFoodThe products may have come into contact with equipment used to process the country ham the supplier recalled for Listeria monocytogenes.
Oct 4, 2018Ukrop's Homestyle Foods, LLCFoodThe products may have come into contact with equipment used to process the country ham the supplier recalled for Listeria monocytogenes.
Oct 3, 2018Silver Star BrandsDrugsMicrobial Contamination of Non-Sterile Products
Oct 3, 2018Silver Star BrandsDrugsMicrobial Contamination of Non-Sterile Products
Oct 3, 2018Silver Star BrandsDrugsMicrobial Contamination of Non-Sterile Products
Oct 3, 2018Silver Star BrandsDrugsMicrobial Contamination of Non-Sterile Product
Oct 2, 2018APOLLO FOOD INTERNATIONAL INC.FoodProduct contains undeclared eggs.
Oct 2, 2018CFS West Holdings IncFoodA complaint received from a customer that a case of Creamy Ranch with Garlic was mislabeled as Horseradish Sauce. The ranch dressing…

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.