Home / Months / May 2019

FDA Warning Letters, 483s and Recalls: May 2019

FDA enforcement records dated May 2019: 0 warning letters outside tobacco, 59 OAI inspections and 69 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, 2019CGA LimitedDrugsTrinidad & Tobago
May 31, 2019Heliora Laboratories Pty Ltd.DrugsAustralia
May 31, 2019QuVa Pharma, Inc.DrugsUnited States
May 31, 2019Westlake IVF, LLCBiologicsUnited States
May 31, 2019Zhejiang Huahai Pharmaceutical Co., Ltd.DrugsChina
May 30, 2019Grace Analytical Lab IncDrugsUnited States
May 30, 2019ITL Asia Pacific Sdn BhdDevicesMalaysia
May 29, 2019Harold Brey & Sons Inc.Food/CosmeticsUnited States
May 29, 2019Pharmaceutical Innovations, Inc.DevicesUnited States
May 28, 2019HealthPartners Institute IRBDevicesUnited States
May 28, 2019Market America IncFood/CosmeticsUnited States
May 28, 2019W.S. Badger Company, Inc.DrugsUnited States
May 27, 2019Guangzhou Han Ma Automation Control Equipment Co. Ltd.DevicesChina
May 24, 2019AB Seafood Trading Inc.Food/CosmeticsUnited States
May 24, 2019Coral Pharmaceuticals LTDDrugsBahamas
May 24, 2019Golden Grains Bakery CompanyFood/CosmeticsUnited States
May 24, 2019Rainbow Export Processing S.A.Food/CosmeticsCosta Rica
May 24, 2019Tismor Health And Wellness Pty LimitedDrugsAustralia
May 23, 2019LiveyonBiologicsUnited States
May 23, 2019Liveyon Labs IncBiologicsUnited States
May 23, 2019OHM Pharma, Inc.DrugsUnited States
May 23, 2019Warner Herb Co.Food/CosmeticsUnited States
May 21, 2019Ibitta Enterprises, Inc.Food/CosmeticsUnited States
May 21, 2019Jetro Holdings, Inc.Food/CosmeticsUnited States
May 21, 2019Soterion Development, Inc.Food/CosmeticsPanama
May 21, 2019Stoney Marine InternationalFood/CosmeticsUnited States
May 20, 2019Kamerycah IncFood/CosmeticsUnited States
May 20, 2019Nature Essence Small Molecule Co., LTDFood/CosmeticsUnited States
May 17, 2019Bimeda Pomona Inc.VeterinaryUnited States
May 17, 2019Brodt Zenatti Holdings LLCFood/CosmeticsUnited States
May 17, 2019Dandong Shenghai Foodstuff Co. Ltd.Food/CosmeticsChina
May 17, 2019G & C Raw, LLCVeterinaryUnited States
May 17, 2019Life Rising CorporationFood/CosmeticsUnited States
May 16, 2019Synthetopes IncDrugsUnited States
May 16, 2019Vital Care Compounder, IncDrugsUnited States
May 16, 2019Wuxi Contact Electronics Co., Ltd.DevicesChina
May 15, 2019Taizhou Taifa Pharmaceuticals Co., Ltd.DrugsChina
May 14, 2019Hetero Labs Ltd. - Unit IXDrugsIndia
May 14, 2019Inter Asian IncFood/CosmeticsUnited States
May 14, 2019Quality Dairy CompanyFood/CosmeticsUnited States
May 14, 2019Sentiss Pharma Private Ltd.DrugsIndia
May 13, 2019Suntree Snack Foods, LLCFood/CosmeticsUnited States
May 10, 2019Bingbing Pharmaceutical (Hubei) Co., LtdDrugsChina
May 10, 2019LSG Sky Chefs, Inc.Food/CosmeticsUnited States
May 9, 2019K C Pastry Co LLCFood/CosmeticsUnited States
May 9, 2019Susan P. King-Harris, D.P.M.DrugsUnited States
May 8, 2019Brian S. Burks, DVMVeterinaryUnited States
May 7, 20195 Spoke Creamery, LLCFood/CosmeticsUnited States
May 7, 2019Hindy Import IncFood/CosmeticsUnited States
May 7, 2019Marfish, Inc.Food/CosmeticsUnited States
May 7, 2019New Vision Pharmaceuticals LLCDrugsUnited States
May 7, 2019Revital U International, LLCFood/CosmeticsUnited States
May 3, 2019Gilman Cooperative Creamery AssociationVeterinaryUnited States
May 3, 2019Kenlor Industries, Inc.DevicesUnited States
May 3, 2019Midway Co-Op AssociationVeterinaryUnited States
May 3, 2019OSKO, Inc.DevicesUnited States
May 3, 2019Zydus Lifesciences LimitedDrugsIndia
May 2, 2019A.P. Deauville, LLCDrugsUnited States
May 2, 2019Rocky Mountain WDC, 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
FDCA 402(a)(4)System for administration of drugs31
21 CFR 117.35(a)Sanitary operations - Plant sanitation30
21 CFR 820.100(a)Lack of or inadequate procedures30
21 CFR 820.198(a)Lack of or inadequate complaint procedures27
21 CFR 123.6(b)No HACCP plan26
21 CFR 117.10Personnel24
21 CFR 117.35(c)Pest control23
21 CFR 117.130(a)(1)Hazard Analysis - Identification of Hazard20
21 CFR 211.192Written record of investigation incomplete20
21 CFR 211.22(d)Procedures not in writing, fully followed20

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 30, 2019Galemed CorporationDevicesReports of pressure relief manifold venting gas below the standard pressure.
May 30, 2019Galemed CorporationDevicesReports of pressure relief manifold venting gas below the standard pressure.
May 30, 2019Galemed CorporationDevicesReports of pressure relief manifold venting gas below the standard pressure.
May 29, 2019Spectrum Medical Ltd.DevicesPotential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.
May 28, 2019Novis PR, Inc.DrugsLabeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical…
May 27, 2019Deep Foods IncFoodDeep Foods Inc., 1090 Springfield Road, Union, NJ-07083 is initiating a recall of Deep Golden Raisins because of undeclared sulfites.
May 24, 2019Cook Inc.DevicesMultiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an…
May 24, 2019Cook Inc.DevicesMultiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an…
May 24, 2019Cook Inc.DevicesMultiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an…
May 24, 2019Teleflex MedicalDevicesThis voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased…
May 24, 2019Teleflex MedicalDevicesThis voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased…
May 24, 2019Teleflex MedicalDevicesThis voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased…
May 24, 2019Teleflex MedicalDevicesThis voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased…
May 24, 2019Teleflex MedicalDevicesThis voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased…
May 24, 2019Teleflex MedicalDevicesThis voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased…
May 24, 2019Teleflex MedicalDevicesThis voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased…
May 24, 2019Teleflex MedicalDevicesThis voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased…
May 22, 2019ADM - CHICAGOFoodpotential presence of E. coli. O26
May 22, 2019ADM - CHICAGOFoodpotential presence of E. coli. O26
May 22, 2019ADM - CHICAGOFoodpotential presence of E. coli. O26
May 22, 2019ADM - CHICAGOFoodpotential presence of E. coli. O26
May 22, 2019ADM - CHICAGOFoodpotential presence of E. coli. O26
May 22, 2019ADM - CHICAGOFoodpotential presence of E. coli. O26
May 22, 2019ADM - CHICAGOFoodpotential presence of E. coli. O26
May 22, 2019ADM - CHICAGOFoodpotential presence of E. coli. O26
May 22, 2019ADM - CHICAGOFoodpotential presence of E. coli. O26
May 22, 2019ADM - CHICAGOFoodpotential presence of E. coli. O26
May 22, 2019ADM - CHICAGOFoodpotential presence of E. coli. O26
May 22, 2019ADM - CHICAGOFoodpotential presence of E. coli. O26
May 22, 2019ADM - CHICAGOFoodpotential presence of E. coli. O26
May 22, 2019ADM - CHICAGOFoodpotential presence of E. coli. O26
May 22, 2019ADM - CHICAGOFoodpotential presence of E. coli. O26
May 22, 2019ADM - CHICAGOFoodpotential presence of E. coli. O26
May 22, 2019ADM - CHICAGOFoodpotential presence of E. coli. O26
May 22, 2019ADM - CHICAGOFoodpotential presence of E. coli. O26
May 22, 2019ADM - CHICAGOFoodpotential presence of E. coli. O26
May 22, 2019ADM - CHICAGOFoodpotential presence of E. coli. O26
May 22, 2019Classic Salads, LLCFoodSuppliers pre harvest field test was returned positive for Salmonella
May 22, 2019New Seasons Market LLCFoodBacon Shallot Potato Salad was recalled due to undeclared egg.
May 21, 2019Hearthside Food SolutionsFoodUndeclared egg
May 21, 2019Heritage Pharmaceuticals, Inc.DrugsNon-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate…
May 21, 2019Heritage Pharmaceuticals, Inc.DrugsNon-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate…
May 21, 2019Wegmans Food Markets, Inc.FoodWegman's seafood salad was mislabeled using old labels that do not declare the milk allergen.
May 20, 2019Mothers' Milk Bank At AustinFoodPositive microbiological culture for bacillus cereus
May 17, 2019House Of Spices India, Inc.FoodProduct contains elevated levels of undeclared Sulfites
May 17, 2019U.S. Tov, Inc.FoodNew York State Department of Agriculture and Markets sampled and tested Rattan Roots in Brine and found high levels of sulfites which are…
May 15, 2019Brodt Zanatti Holding LlcFoodThe recall was initiated due to New York City Department of Health and Mental Hygiene laboratory results from two samples of Karawan brand…
May 15, 2019Brodt Zanatti Holding LlcFoodThe recall was initiated due to New York City Department of Health and Mental Hygiene laboratory results from two samples of Karawan brand…
May 15, 2019Brodt Zanatti Holding LlcFoodThe recall was initiated due to New York City Department of Health and Mental Hygiene laboratory results from two samples of Karawan brand…
May 15, 2019Brodt Zanatti Holding LlcFoodThe recall was initiated due to New York City Department of Health and Mental Hygiene laboratory results from two samples of Karawan brand…
May 15, 2019COOLHAUSFoodProduct contains undeclared milk
May 14, 2019Edwards Lifesciences, LLCDevicesPossibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during cardiopulmonary bypass, the heart can fill…
May 14, 2019Renaissance Food Group LLCFoodUndeclared soy
May 14, 2019Renaissance Food Group LLCFoodUndeclared soy
May 11, 2019Novartis Pharmaceuticals Corp.DrugsCross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
May 10, 2019Medline Industries IncDevicesThis recall is a sub recall to BD s recent Class I recall for the Alaris Pump Infusion Set due to an issue with the consistency of the…
May 10, 2019Teleflex MedicalDevicesReported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.
May 9, 2019DESHI DISTRIBUTORS, LLCFoodNYS found elevated levels of undeclared Sulfites in dried Deshi Golden Raisins
May 7, 2019Mecox Bay DairyFoodNYSDAM found Listeria Monocytogenes in Cheese during sampling.
May 6, 2019Becton Dickinson & CompanyDevicesAn incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with…
May 6, 2019Seven Seas International USA LLCFoodProduct was found positive for Listeria monocytogenes.
May 6, 2019Stiff Boy LLCDrugsMarketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis.
May 3, 2019Icco Cheese Co IncFoodProduct contains undeclared Allergens: Walnuts & Pecans
May 3, 2019Icco Cheese Co IncFoodProduct contains undeclared Allergens: Walnuts & Pecans
May 3, 2019Medline Industries IncDevicesThe Vyaire enFlow disposable cartridge was recalled due to the potential for unsafe aluminum levels to elute into the infusate. The Use of…
May 2, 2019Life Rising CorporationFoodHigh lead levels in products
May 2, 2019Life Rising CorporationFoodHigh lead levels in products
May 1, 2019B. Braun Medical, Inc.DevicesPotential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site…
May 1, 2019Maine Wild Blueberry CompanyFoodCustomer found Listeria Monocytogenes in Blueberries after internal sampling. Product was never distributed to consumers.

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.