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FDA Warning Letters, 483s and Recalls: May 2018

FDA enforcement records dated May 2018: 0 warning letters outside tobacco, 41 OAI inspections and 45 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
May 31, 2018Alle Processing Corp.Food/CosmeticsUnited States
May 30, 2018Tropical Seas, Inc.DrugsUnited States
May 25, 2018Years To Your Health, Inc.Food/CosmeticsUnited States
May 24, 20185 Spoke Creamery, LLCFood/CosmeticsUnited States
May 24, 2018Smart ToothpicksTobaccoUnited States
May 23, 2018AB Seafood Trading Inc.Food/CosmeticsUnited States
May 23, 2018LXR BiotechFood/CosmeticsUnited States
May 22, 2018Central Valley Ag CooperativeVeterinaryUnited States
May 22, 2018UPRIVER Aquaculture Inc.Food/CosmeticsUnited States
May 21, 2018Philips Respironics, Inc.DevicesUnited States
May 18, 2018Barox Co., Ltd.DrugsKorea (the Republic of)
May 18, 2018Baxter Hospitalar LtdaDrugsBrazil
May 18, 2018DynaPro International, Inc.Food/CosmeticsUnited States
May 18, 2018Eagle Pharma Outsourcing LLCDrugsUnited States
May 18, 2018Jinan Jinda Pharmaceutical Chemistry Co., Ltd.DrugsChina
May 18, 2018LNZRO Pizza Empire IncFood/CosmeticsUnited States
May 18, 2018TruVision Health LLCFood/CosmeticsUnited States
May 17, 2018Duckworth & Kent, Ltd.DevicesUnited Kingdom
May 17, 2018Gonzalez And Nietos, LLCFood/CosmeticsUnited States
May 16, 2018Rising Pharma Holdings, IncDrugsUnited States
May 15, 2018Medtronic Puerto Rico Operations Co.DevicesUnited States
May 14, 2018Asael Farr & Sons, Inc.Food/CosmeticsUnited States
May 14, 2018Medtronic, Inc.DevicesUnited States
May 12, 2018Megafine Pharma (P) LimitedDrugsIndia
May 11, 2018Boule Medical ABDevicesSweden
May 11, 2018Complete H2O Minerals, Inc.Food/CosmeticsUnited States
May 11, 2018Isomers Laboratories Inc.DrugsCanada
May 11, 2018Prescription Dispensing Laboratories Inc.DrugsUnited States
May 11, 2018Rushing Waters Fisheries, LLCFood/CosmeticsUnited States
May 10, 2018Mibo Medical GroupDevicesUnited States
May 10, 2018Pietrobon E Cia Ltda.DrugsBrazil
May 9, 2018BioMatrix C/O Specialty Fulfilment CenterFood/CosmeticsUnited States
May 9, 2018Natural Sea Product Co.,Ltd.Food/CosmeticsThailand
May 7, 2018CAO Group, Inc.DevicesUnited States
May 7, 2018Coast Quality Pharmacy, LLCDrugsUnited States
May 7, 2018John MeadorsDevicesUnited States
May 3, 2018CV East, LLCFood/CosmeticsUnited States
May 3, 2018Maui Preserved, LLCFood/CosmeticsUnited States
May 3, 2018Neptune Manufacturing IncFood/CosmeticsUnited States
May 3, 2018Texas Aloe Corporation, Inc.Food/CosmeticsUnited States
May 2, 2018Jinher, Inc.Food/CosmeticsUnited States

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 plan28
21 CFR 117.35(a)Sanitary operations - Plant sanitation26
21 CFR 117.35(c)Pest control24
21 CFR 123.11(b)Sanitation monitoring documentation23
21 CFR 123.6(c)(1)Food safety hazards21
21 CFR 820.100(a)Lack of or inadequate procedures21
FDCA 402(a)(4)System for administration of drugs18
21 CFR 117.40Equipment and utensils - Design and maintenance17
21 CFR 820.198(a)Lack of or inadequate complaint procedures17
21 CFR 117.80(c)Process Control Measures16

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
May 29, 2018Shearers Foods, LlcFoodMilk allergen was not declared on the labeling of the product.
May 25, 2018Global Commodities IncFoodProduct contains high levels of undeclared sulfites (2901 ppm).
May 24, 2018Allergan, PLC.DrugsContraceptive Tablets Out of Sequence.
May 24, 2018Dough-To-Go IncFoodUndeclared allergen; walnuts
May 23, 2018New Seasons Market LLCFoodMini Butter Croissants are recalled because the Ingredients statement and Contains statement do not declare EGG.
May 23, 2018New Seasons Market LLCFoodMini Chocolate Croissants are recalled because the Ingredients statement and Contains statement do not declare EGG. In addition, Mini…
May 22, 2018Lake Michigan Distilling Co LLCFoodLake Michigan Distilling, LLC, dba Ethanol Extraction has initiated a voluntary recall of Ethanol Extraction s 190 Proof Non-Denatured…
May 21, 2018Desly International Corp.FoodProducts contain undeclared peanuts.
May 21, 2018Desly International Corp.FoodProducts contain undeclared peanuts.
May 18, 2018BERLIN HEART GMBHDevicesThere is a potential for a disruption in one or more of the triple layer membranes of the ventricular assist device. Recall occurred in…
May 18, 2018Hee Chang Dairy & Food Co., LTDFoodDuring a FDA foreign inspection, it was found that four products did not declare allergens.
May 18, 2018New Century Snacks LLCFoodFirm was notified by customer that some bags of Tropical Trail mix contain Yogurt Trail mix and therefore do not declare milk, soy, wheat…
May 18, 2018Pious LionFoodThe firm was notified by the North Carolina Dept. of Agriculture that the product contains Salmonella.
May 18, 2018Pious LionFoodThe firm was notified by the North Carolina Dept. of Agriculture that the product contains Salmonella.
May 18, 2018Qiagen Sciences, Inc.DevicesPotential for control line not appearing on the test strip
May 17, 2018Shoreside Enterprises Inc.DrugsMarketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of…
May 17, 2018Shoreside Enterprises Inc.DrugsMarketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of…
May 17, 2018Ziyad Brothers Importing, Inc.FoodZiyad Brothers Importing is voluntarily recalling its Ziyad Brand Tahini, 8 oz. 16 oz., 1/2 gallon and 32 oz. sizes due to potential…
May 15, 2018BLM Products U. VertriebsgesFoodBLM Prod.-und Vertriebsges.mbH & Co. KG has initiated a voluntary recall of Priano Rosso Pesto Sauce, 6.7 oz. packaged in glass jars due to…
May 15, 2018Draeger Medical Systems, Inc.DevicesUsers have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement.
May 15, 2018Draeger Medical Systems, Inc.DevicesUsers have misinterpreted the display for out of range measurement indicated by the blinking "-0-" to mean a zero measurement
May 14, 2018Michael's Bakery Products, LLCFoodThe product contains pecans which are not declared on the product labeling.
May 10, 2018Caudill Sprouting LLCFoodThe firm's seeds have been linked in a multistate outbreak of Salmonella Montevideo and Salmonella Cubana infections.
May 8, 2018Apotex Inc.DrugsSubpotent Drug: High Levels of Impurities Resulting in Decrease Potency
May 8, 2018Apotex Inc.DrugsSubpotent Drug: High Levels of Impurities Resulting in Decrease Potency
May 8, 2018Vyaire MedicalDevicesAn error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen…
May 8, 2018Vyaire MedicalDevicesAn error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen…
May 7, 2018Biosense Webster, Inc.DevicesWhen attempting to recapture the 32-mm device, the tip of the delivery sheath may fold or buckle, resulting in increased retraction force…
May 7, 2018Morgan Foods, Inc.FoodMorgan Foods, Inc. is voluntarily recalling Great Value Brand Gluten Free Tomato Soup due to undeclared allergen milk.
May 3, 2018Maquet Datascope Corp - Cardiac Assist DivisionDevicesIngress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.
May 2, 2018Badger Botanicals LLCFoodRecalling Red Suma, Green Suma, Red Hulu 2, Green Hulu 2 Kratom products due to potential salmonella.
May 2, 2018Badger Botanicals LLCFoodRecalling Red Suma, Green Suma, Red Hulu 2, Green Hulu 2 Kratom products due to potential salmonella.
May 2, 2018Badger Botanicals LLCFoodRecalling Red Suma, Green Suma, Red Hulu 2, Green Hulu 2 Kratom products due to potential salmonella.
May 2, 2018Badger Botanicals LLCFoodRecalling Red Suma, Green Suma, Red Hulu 2, Green Hulu 2 Kratom products due to potential salmonella.
May 2, 2018Flowers Bakery Of Montgomery LLCFoodUndeclared allergens: Product was mislabeled due to undeclared Milk and Soy
May 2, 2018Flowers Bakery Of Montgomery LLCFoodUndeclared allergens: Product was mislabeled due to undeclared Milk and Soy
May 2, 2018HeartwareDevicesPossible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the…
May 2, 2018Utz Quality Food IncFoodUtz Quality Foods, LLC, is voluntarily recalling select expiration dates of some Golden Flake, Good Health, Utz and Weis Brand Tortilla…
May 2, 2018Utz Quality Food IncFoodUtz Quality Foods, LLC, is voluntarily recalling select expiration dates of some Golden Flake, Good Health, Utz and Weis Brand Tortilla…
May 2, 2018Utz Quality Food IncFoodUtz Quality Foods, LLC, is voluntarily recalling select expiration dates of some Golden Flake, Good Health, Utz and Weis Brand Tortilla…
May 2, 2018Utz Quality Food IncFoodUtz Quality Foods, LLC, is voluntarily recalling select expiration dates of some Golden Flake, Good Health, Utz and Weis Brand Tortilla…
May 2, 2018Utz Quality Food IncFoodUtz Quality Foods, LLC, is voluntarily recalling select expiration dates of some Golden Flake, Good Health, Utz and Weis Brand Tortilla…
May 2, 2018Utz Quality Food IncFoodUtz Quality Foods, LLC, is voluntarily recalling select expiration dates of some Golden Flake, Good Health, Utz and Weis Brand Tortilla…
May 1, 2018AuroMedics Pharma LLCDrugsPresence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
May 1, 2018AuroMedics Pharma LLCDrugsPresence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles…

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.