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FDA Warning Letters, 483s and Recalls: August 2018

FDA enforcement records dated August 2018: 0 warning letters outside tobacco, 48 OAI inspections and 56 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 31, 2018Gold Star Smoked Fish Corp.Food/CosmeticsUnited States
Aug 31, 2018Panther James LLC.Food/CosmeticsUnited States
Aug 30, 2018Syfrett Feed Company, Inc.VeterinaryUnited States
Aug 29, 2018B. JAIN PHARMACEUTICALS PRIVATE LIMITEDDrugsIndia
Aug 28, 2018Antibioticos Do Brasil LtdaDrugsBrazil
Aug 28, 2018Delarange Cosmetics BVDrugsNetherlands
Aug 28, 2018Pharm D Solutions, LLCDrugsUnited States
Aug 28, 2018RTI Surgical, Inc.BiologicsUnited States
Aug 28, 2018Salud Natural Entrepreneur, Inc.Food/CosmeticsUnited States
Aug 27, 2018H & T Seafood, Inc.Food/CosmeticsUnited States
Aug 24, 2018NutriResearch IncFood/CosmeticsUnited States
Aug 24, 2018Valentin Management, Inc.Food/CosmeticsUnited States
Aug 23, 2018ASP CaresDrugsUnited States
Aug 23, 2018Hanna's Herb ShopFood/CosmeticsUnited States
Aug 23, 2018Hennepin County Med Ctr (Minneapolis) IRB #1DrugsUnited States
Aug 20, 2018Pharmasol CorporationDrugsUnited States
Aug 18, 2018DC Laboratories Inc.,TobaccoUnited States
Aug 17, 2018HomeChoice PartnersDrugsUnited States
Aug 17, 2018Lopez Gonzalez Santana CorporationFood/CosmeticsUnited States
Aug 16, 2018Phi SciencesFood/CosmeticsUnited States
Aug 15, 2018Hospira, Inc.VeterinaryUnited States
Aug 15, 2018JLM Manufacturing LLCFood/CosmeticsUnited States
Aug 15, 2018UE CHOON LEE CO.,LTDFood/CosmeticsThailand
Aug 15, 2018Westlab Pharmacy, Inc.DrugsUnited States
Aug 14, 2018Honeywood Ltd.Food/CosmeticsUnited Kingdom
Aug 13, 2018Morley Land And Cattle CompanyVeterinaryUnited States
Aug 10, 2018Bausch & Lomb IncorporatedDrugsUnited States
Aug 10, 2018Confidence U.S.A. Inc.Food/CosmeticsUnited States
Aug 10, 2018Jelliffe Dairy FarmVeterinaryUnited States
Aug 10, 2018J.M. Huber Micropowders, IncVeterinaryUnited States
Aug 10, 2018Peripheral Visions, Inc.DevicesUnited States
Aug 9, 2018Hangzhou SunKing Nonwovens Co., Ltd.DrugsChina
Aug 9, 2018Soleo Cosmetic CO.,LTDDrugsKorea (the Republic of)
Aug 9, 2018Uustar CorporationFood/CosmeticsUnited States
Aug 7, 2018JW Closeout, LLC (Formerly J And L Grocery, LLC)Food/CosmeticsUnited States
Aug 7, 2018Taylor Farms Southwest, LLCFood/CosmeticsUnited States
Aug 6, 2018InnoMark, Inc.Food/CosmeticsUnited States
Aug 6, 2018Juices International, Inc.Food/CosmeticsUnited States
Aug 3, 2018Anicare Pharmaceuticals Pvt Ltd.DrugsIndia
Aug 3, 2018Vita Pharmacy, LLCDrugsUnited States
Aug 3, 2018Zhejiang Huahai PharmaceuticalDrugsChina
Aug 2, 2018Auro Pharmacies, Inc.DrugsUnited States
Aug 2, 2018Laboratorios Quantium LlcDrugsUnited States
Aug 2, 2018Total Thermal Imaging, Inc.DevicesUnited States
Aug 2, 2018Walnut Ridge Farm 1Food/CosmeticsUnited States
Aug 1, 2018Becton Dickinson Medical SystemsDevicesUnited States
Aug 1, 2018Cole D. Younger, PhDVeterinaryUnited States
Aug 1, 2018Porton Biopharma LimitedDrugsUnited Kingdom

Most-cited Form 483 sections

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

CFR sectionObservationCitations
21 CFR 1.502(a)Maintain, follow FSVP67
21 CFR 820.100(a)Lack of or inadequate procedures31
21 CFR 820.198(a)Lack of or inadequate complaint procedures27
21 CFR 117.35(c)Pest control26
FDCA 402(a)(4)Records review prior to shipment for slaughter21
21 CFR 117.35(a)Sanitary operations - Plant sanitation20
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures17
21 CFR 117.20(b)Plant construction and design16
21 CFR 117.80(c)Process Control Measures16
21 CFR 123.11(b)Sanitation monitoring documentation15

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 28, 2018Alcon Research, LTD.DevicesAnalysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically…
Aug 28, 2018Alcon Research, LTD.DevicesAnalysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically…
Aug 28, 2018Alcon Research, LTD.DevicesAnalysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically…
Aug 28, 2018Alcon Research, LTD.DevicesAnalysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically…
Aug 27, 2018QuVa Pharma, Inc.DrugsSubpotent Drug: Product may not have the active ingredient present in the bag.
Aug 27, 2018SCA Pharmaceuticals, Inc.DrugsPresence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
Aug 23, 2018HellolifeDrugsMicrobial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus…
Aug 23, 2018HellolifeDrugsMicrobial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus…
Aug 23, 2018HellolifeDrugsMicrobial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus…
Aug 23, 2018HellolifeDrugsMicrobial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus…
Aug 21, 2018Accord Healthcare, Inc.DrugsProduct Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone…
Aug 18, 2018Air Stream Corp.FoodThe product may be contaminated with Listeria monocytogenes.
Aug 18, 2018Air Stream Corp.FoodThe product may be contaminated with Listeria monocytogenes.
Aug 17, 2018Hidroponicos Brownia, S.P.R. De R.L.FoodDuring FDA foreign inspection of manufacturer, it was discovered that milk, wheat and soy were not declared as sub ingredients or in the…
Aug 17, 2018Hidroponicos Brownia, S.P.R. De R.L.FoodDuring FDA foreign inspection of manufacturer, it was discovered that milk, wheat and soy were not declared as sub ingredients or in the…
Aug 17, 2018Neighbors LLCFoodUndeclared almonds on the labeling
Aug 15, 2018Hetero Labs Limited Unit VDrugsLabeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Aug 15, 2018Marsee Foods IncFoodChocolate Chip Cookies are recalled because cookies may contain undeclared peanuts.
Aug 15, 2018Marsee Foods IncFoodGinger Spice Cookies are recalled because cookies may contain undeclared peanuts.
Aug 15, 2018Marsee Foods IncFoodOatmeal Raisin Cookies are recalled because cookies may contain undeclared peanuts.
Aug 14, 2018SALT & STRAW LLCFoodChocolate Gooey Brownie Ice Cream is recalled due to possible undeclared peanuts.
Aug 13, 2018Living Well Remedies, LLCDrugsMicrobial Contamination of Non-Sterile Products: Weight Away Remedy is being recall due to out of specification microbial results.
Aug 7, 2018Medtronic Inc.DevicesThere is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.
Aug 7, 2018Medtronic Inc.DevicesThere is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.
Aug 6, 2018Country Favor Inc.FoodProduct contains high levels of undeclared sulfites.
Aug 3, 2018Product Quest Manufacturing LLCDrugsMicrobial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.
Aug 3, 2018Westminster Pharmaceuticals LLCDrugsFailed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally…
Aug 3, 2018Westminster Pharmaceuticals LLCDrugsFailed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally…
Aug 3, 2018Westminster Pharmaceuticals LLCDrugsFailed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally…
Aug 3, 2018Westminster Pharmaceuticals LLCDrugsFailed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally…
Aug 3, 2018Westminster Pharmaceuticals LLCDrugsFailed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally…
Aug 3, 2018Zakah Life LLCFoodThe firm distributes dietary supplements which contain Mitragyna speciosa (kratom) a dietary ingredient with inadequate information to…
Aug 3, 2018Zakah Life LLCFoodThe firm distributes dietary supplements which contain Mitragyna speciosa (kratom) a dietary ingredient with inadequate information to…
Aug 2, 2018Ventana Medical Systems IncDevicesLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018Ventana Medical Systems IncDevicesLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018Ventana Medical Systems IncDevicesLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018Ventana Medical Systems IncDevicesLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018Ventana Medical Systems IncDevicesLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018Ventana Medical Systems IncDevicesLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018Ventana Medical Systems IncDevicesLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018Ventana Medical Systems IncDevicesLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018Ventana Medical Systems IncDevicesLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018Ventana Medical Systems IncDevicesLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018Ventana Medical Systems IncDevicesLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018Ventana Medical Systems IncDevicesLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018Ventana Medical Systems IncDevicesLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers
Aug 2, 2018Ventana Medical Systems IncDevicesLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018Ventana Medical Systems IncDevicesLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018Ventana Medical Systems IncDevicesLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018Ventana Medical Systems IncDevicesLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018Ventana Medical Systems IncDevicesLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018Ventana Medical Systems IncDevicesLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018Ventana Medical Systems IncDevicesLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018Ventana Medical Systems IncDevicesLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 1, 2018HP Hood LLCFoodHP Hood LLC, has initiated a recall of Blue Diamond Almond Breeze Almond Milk, Half Gallon, because the product tested positive for milk…
Aug 1, 2018Sweet Earth Inc.FoodFirm received complaints of Sweet Earth Aloha BBQ Quesadilla packages that contain Mile High Quesadillas. Ingredient statement on outer…

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.