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FDA Warning Letters, 483s and Recalls: August 2019

FDA enforcement records dated August 2019: 0 warning letters outside tobacco, 51 OAI inspections and 11 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
Aug 30, 2019Raw Advantage Processing LLCVeterinaryUnited States
Aug 30, 2019Windlas Healthcare Private LimitedDrugsIndia
Aug 29, 2019Be Natural Organics, LLCFood/CosmeticsUnited States
Aug 29, 2019Reliant Compounded Solutions Monroe, LLCDrugsUnited States
Aug 28, 2019Crazy Bakery LLCFood/CosmeticsUnited States
Aug 28, 2019EyePoint US, Inc.DrugsUnited States
Aug 28, 2019Williams & Son Livestock, LLC.VeterinaryUnited States
Aug 27, 2019APIA EXPORT FISH PACKERS LTDFood/CosmeticsWestern Samoa
Aug 27, 2019Trilogy Laboratories, LLCDrugsUnited States
Aug 26, 2019Cerreta Candy Company, Inc.Food/CosmeticsUnited States
Aug 26, 2019Texas Tripe, IncVeterinaryUnited States
Aug 23, 2019Ipca Laboratories LimitedDrugsIndia
Aug 23, 2019USHIO GERMANY GmbHDevicesGermany
Aug 22, 2019Brigham And Women's Hospital, Inc., TheDrugsUnited States
Aug 22, 2019Chemland Co., Ltd.DrugsKorea (the Republic of)
Aug 22, 2019JHS SVENDGAARD LABORATORIES LIMITEDDrugsIndia
Aug 22, 2019Vaish Vik Foods Pvt LtdFood/CosmeticsIndia
Aug 21, 2019The Dragontree Apothecary LLCFood/CosmeticsUnited States
Aug 21, 2019Valentin Management, Inc.Food/CosmeticsUnited States
Aug 20, 2019JIANGXI HENGDING FOOD CO., LTDFood/CosmeticsChina
Aug 19, 2019SevenFood/CosmeticsUnited States
Aug 16, 2019Apollo Health And Beauty Care, Inc.DrugsCanada
Aug 16, 2019Corporativo Serysi, S. De R.L. De C.V.DrugsMexico
Aug 16, 2019Madhu Instruments Private LimitedDrugsIndia
Aug 16, 2019Reproductive Technologies, Inc.BiologicsUnited States
Aug 16, 2019SonoCine Inc.DevicesUnited States
Aug 16, 2019Strong Fertility CenterBiologicsUnited States
Aug 16, 2019Syfrett Feed Company, Inc.VeterinaryUnited States
Aug 15, 2019Mars Wrigley Confectionery US, LLCFood/CosmeticsUnited States
Aug 15, 2019R-Garden LLCFood/CosmeticsUnited States
Aug 15, 2019Water-Jel Technologies, LLCDrugsUnited States
Aug 14, 2019Fresh & Ready Food GroupFood/CosmeticsUnited States
Aug 14, 2019KRS Global Biotechnology, IncDrugsUnited States
Aug 9, 2019Lake Chemicals Private LimitedDrugsIndia
Aug 9, 2019Medoz Pharmacy Of Polk IncDrugsUnited States
Aug 9, 2019Rapid Equine Solutions, LLCVeterinaryUnited States
Aug 9, 2019Tec Laboratories, Inc.DrugsUnited States
Aug 8, 2019Aerolase Corp.DevicesUnited States
Aug 8, 2019Arizona Sunland Foods IncFood/CosmeticsUnited States
Aug 8, 2019Ernest Jackson & Co., Ltd.DrugsUnited Kingdom
Aug 6, 2019Alpha Feed Mill, IncVeterinaryUnited States
Aug 6, 2019Bravo Packing, Inc.VeterinaryUnited States
Aug 6, 2019Randol Mill PharmacyDrugsUnited States
Aug 6, 2019Yibin Lihao Bio-Technical Co., Ltd.DrugsChina
Aug 5, 2019JE Rich CompanyVeterinaryUnited States
Aug 5, 2019JE Rich CompanyVeterinaryUnited States
Aug 5, 2019MISSION LLCFood/CosmeticsUnited States
Aug 2, 2019Consolidated Chemical, IncDrugsUnited States
Aug 2, 2019Guangzhou Tinci Materials Technology Co., Ltd.DrugsChina
Aug 2, 2019James W. Findling, M.D.DrugsUnited States
Aug 1, 2019Silfradent SrlDevicesItaly

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 plan35
21 CFR 117.35(a)Sanitary operations - Plant sanitation34
FDCA 501(a)(2)(A)Vermin, production area32
21 CFR 117.35(c)Pest control29
21 CFR 820.100(a)Lack of or inadequate procedures27
21 CFR 117.20(b)Plant construction and design25
21 CFR 123.11(b)Sanitation monitoring documentation25
21 CFR 1.502(a)Develop FSVP25
21 CFR 820.198(a)Lack of or inadequate complaint procedures24
21 CFR 117.10Personnel22

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
Aug 30, 2019Hiland Dairy FoodsFoodUndeclared milk
Aug 30, 2019Plastikon Healthcare LLCDrugsMicrobial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.
Aug 23, 2019Krasnyi Oktyabr Inc. USAFoodProduct contains undeclared sulfites.
Aug 23, 2019Krasnyi Oktyabr Inc. USAFoodProduct contains undeclared sulfites.
Aug 22, 2019Great One Trading Inc.FoodProducts contain undeclared allergen, specifically egg.
Aug 22, 2019Great One Trading Inc.FoodProducts contain undeclared allergen, specifically egg.
Aug 22, 2019LivaNova USA IncDevicesSentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but devices will continue to be…
Aug 22, 2019Thoratec Switzerland GMBHDevicesReports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).
Aug 20, 2019Whole Foods MarketFoodUndeclared egg
Aug 9, 2019Dole Fresh Vegetables IncFoodMichigan Department of Agriculture sampled and tested spinach and received a positive result for Salmonella.
Aug 9, 2019Medtronic Navigation, Inc.DevicesEntry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific…

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.