Home / Months / April 2019

FDA Warning Letters, 483s and Recalls: April 2019

FDA enforcement records dated April 2019: 0 warning letters outside tobacco, 41 OAI inspections and 39 Class I recalls. FDA publishes some records weeks after their date, so recent months can still grow.

· All months ·

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
Apr 29, 2019Ripley Dairy LLCFood/CosmeticsUnited States
Apr 26, 2019Jon B. Cole, MDDrugsUnited States
Apr 26, 2019MIN JIANG FOOD STORE INCFood/CosmeticsUnited States
Apr 26, 2019Raw Farm, LLCFood/CosmeticsUnited States
Apr 25, 2019Crispy Delight Corp.Food/CosmeticsUnited States
Apr 25, 2019Jinher, Inc.Food/CosmeticsUnited States
Apr 25, 2019Port Clyde Fresh Catch, Inc.Food/CosmeticsUnited States
Apr 24, 2019Yost Foods, IncFood/CosmeticsUnited States
Apr 23, 2019Bakehouse Bread Company LLCFood/CosmeticsUnited States
Apr 23, 2019Lauren R. Klein, M.D.DrugsUnited States
Apr 23, 2019QuVa Pharma, Inc.DrugsUnited States
Apr 22, 2019Colonia Care PharmacyDrugsUnited States
Apr 22, 2019Darling Ingredients, Inc.VeterinaryUnited States
Apr 22, 2019Naturavit IncFood/CosmeticsUnited States
Apr 19, 2019Altaire Pharmaceuticals, Inc.DrugsUnited States
Apr 19, 2019Linhai Tianyu Pharmaceutical Co., Ltd.DrugsChina
Apr 18, 2019Norbrook Laboratories LimitedVeterinaryUnited Kingdom
Apr 18, 2019Sejun Food Co., LtdFood/CosmeticsKorea (the Republic of)
Apr 17, 2019BMF, Inc.Food/CosmeticsUnited States
Apr 16, 2019KVK Tech, Inc.DrugsUnited States
Apr 16, 2019Medisca, Inc.DrugsUnited States
Apr 16, 2019Torrent Pharmaceuticals LimitedDrugsIndia
Apr 12, 2019Sofie Co.DrugsUnited States
Apr 12, 2019Zhejiang Tianyu Pharmaceutical Co LtdDrugsChina
Apr 9, 2019Apozeal Pharmaceuticals Inc.DrugsUnited States
Apr 9, 2019Nutra Solutions USA, Inc.Food/CosmeticsUnited States
Apr 8, 2019Sinu Co., LtdFood/CosmeticsKorea (the Republic of)
Apr 8, 2019The Compounding PharmacyDrugsUnited States
Apr 5, 2019Anderson Compounding Pharmacy, Inc.DrugsUnited States
Apr 5, 2019Hans Kissle Company, LLCFood/CosmeticsUnited States
Apr 5, 2019Jiangsu NHWA Pharmaceutical Co., Ltd.DrugsChina
Apr 5, 2019Laboratorio Reig Jofre, S.A.DrugsSpain
Apr 5, 2019Osung General Food Co. LtdFood/CosmeticsKorea (the Republic of)
Apr 4, 2019Balamurali K. Ambati , M.D., Ph.D.DrugsUnited States
Apr 4, 2019Clinicon CorpDevicesUnited States
Apr 4, 2019EZ Salsa, IncFood/CosmeticsUnited States
Apr 4, 2019Jeffrey W. Groves, M.D.DevicesUnited States
Apr 4, 2019Nexagen, LLCFood/CosmeticsUnited States
Apr 4, 2019The Skin Atelier, Inc.DrugsUnited States
Apr 3, 2019Invitrx Therapeutics Inc.BiologicsUnited States
Apr 2, 2019Marine Healthfoods LtdFood/CosmeticsIreland

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 drugs30
21 CFR 117.35(a)Sanitary operations - Plant sanitation29
21 CFR 820.100(a)Lack of or inadequate procedures28
21 CFR 1.502(a)Develop FSVP23
21 CFR 820.198(a)Lack of or inadequate complaint procedures22
21 CFR 117.35(c)Pest control20
21 CFR 123.6(b)No HACCP plan20
21 CFR 117.10Personnel19
21 CFR 117.20(b)Plant construction and design17
21 CFR 211.192Written record of investigation incomplete17

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
Apr 30, 2019Par Pharmaceutical, Inc.DrugsPresence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Apr 30, 2019Topnotch Foods IncFoodCalifornia Department of Public Health inspection at the facility found undeclared milk (from whey).
Apr 26, 2019Terumo Medical CorporationDevicesThere is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from…
Apr 26, 2019Terumo Medical CorporationDevicesThere is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from…
Apr 26, 2019Terumo Medical CorporationDevicesThere is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from…
Apr 23, 2019D.B.P. DistributionDrugsMarketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil.
Apr 19, 2019Alvogen, IncDrugsProduct Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and…
Apr 16, 2019Denali Ingredients LLCFoodBanana Puddin Base contains an undeclared egg sub-ingredient.
Apr 15, 2019Jensen Tuna IncFoodPotential to be contaminated with Salmonella.
Apr 12, 2019Caito Foods LLC.FoodPotential to be contaminated with Salmonella Carrau
Apr 11, 2019Ethicon Endo-Surgery IncDevicesThe staplers may have an insufficient firing stroke to break the washer and completely form staples.
Apr 11, 2019Ethicon Endo-Surgery IncDevicesThe staplers may have an insufficient firing stroke to break the washer and completely form staples.
Apr 11, 2019Ethicon Endo-Surgery IncDevicesThe staplers may have an insufficient firing stroke to break the washer and completely form staples.
Apr 11, 2019Ethicon Endo-Surgery IncDevicesThe staplers may have an insufficient firing stroke to break the washer and completely form staples.
Apr 11, 2019Ethicon Endo-Surgery IncDevicesThe staplers may have an insufficient firing stroke to break the washer and completely form staples.
Apr 11, 2019Ethicon Endo-Surgery IncDevicesThe staplers may have an insufficient firing stroke to break the washer and completely form staples.
Apr 11, 2019Ethicon Endo-Surgery IncDevicesThe staplers may have an insufficient firing stroke to break the washer and completely form staples.
Apr 11, 2019Ethicon Endo-Surgery IncDevicesThe staplers may have an insufficient firing stroke to break the washer and completely form staples.
Apr 11, 2019Ethicon Endo-Surgery IncDevicesThe staplers may have an insufficient firing stroke to break the washer and completely form staples.
Apr 11, 2019Ethicon Endo-Surgery IncDevicesThe staplers may have an insufficient firing stroke to break the washer and completely form staples.
Apr 11, 2019Ethicon Endo-Surgery IncDevicesThe staplers may have an insufficient firing stroke to break the washer and completely form staples.
Apr 11, 2019Ethicon Endo-Surgery IncDevicesThe staplers may have an insufficient firing stroke to break the washer and completely form staples.
Apr 11, 2019Makzemo LLCFoodProduct contains high levels of lead.
Apr 10, 2019Societe Fromagere De La BrieFoodThe product may be contaminated with Listeria monocytogenes.
Apr 10, 2019Societe Fromagere De La BrieFoodThe product may be contaminated with Listeria monocytogenes.
Apr 9, 2019Great American Marketing CompanyFoodProduct has the potential to be contaminated with Listeria monocytogenes.
Apr 9, 2019Great American Marketing CompanyFoodProduct has the potential to be contaminated with Listeria monocytogenes.
Apr 9, 2019Great American Marketing CompanyFoodProduct has the potential to be contaminated with Listeria monocytogenes.
Apr 9, 2019Great American Marketing CompanyFoodProduct has the potential to be contaminated with Listeria monocytogenes.
Apr 9, 2019Great American Marketing CompanyFoodProduct has the potential to be contaminated with Listeria monocytogenes.
Apr 9, 2019Great American Marketing CompanyFoodProduct has the potential to be contaminated with Listeria monocytogenes.
Apr 9, 2019Great American Marketing CompanyFoodProduct has the potential to be contaminated with Listeria monocytogenes.
Apr 9, 2019Great American Marketing CompanyFoodProduct has the potential to be contaminated with Listeria monocytogenes.
Apr 9, 2019SELECT DISTRIBUTIONS LLCDrugsMarketed without an approved NDA/ANDA: FDA analysis has found the product to be tainted with sildenafil
Apr 8, 2019Integra LifeSciences Corp.DevicesThe firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
Apr 8, 2019Integra LifeSciences Corp.DevicesThe firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
Apr 8, 2019Integra LifeSciences Corp.DevicesThe firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
Apr 5, 2019Brian P. RichardsonDrugsMarketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and tadalafil, two FDA…
Apr 5, 2019Hercules Candy CompanyFoodProduct may contain undeclared peanuts

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.