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FDA Warning Letters, 483s and Recalls: June 2018

FDA enforcement records dated June 2018: 0 warning letters outside tobacco, 41 OAI inspections and 72 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
Jun 29, 2018B. Braun US Pharmaceutical Manufacturing, LLCDrugsUnited States
Jun 29, 2018Catalent Ontario LimitedDrugsCanada
Jun 29, 2018Kerry IncFood/CosmeticsUnited States
Jun 29, 2018Nature & Nature Co., Ltd.DrugsKorea (the Republic of)
Jun 28, 2018Lakeview Dairy, LLCVeterinaryUnited States
Jun 27, 2018Faro Ted OwiesyDrugsUnited States
Jun 27, 2018Ocean Providence Minneapolis LLCFood/CosmeticsUnited States
Jun 27, 2018Vilvet Pharmaceuticals Inc.DrugsUnited States
Jun 26, 2018Electric Lotus, LLCTobaccoUnited States
Jun 25, 2018DS Services Of America, IncFood/CosmeticsUnited States
Jun 25, 2018Evoqua Water Technologies LLCDevicesUnited States
Jun 22, 2018Genetech IncBiologicsUnited States
Jun 22, 2018Hyundai Bioscience Co., Ltd.DrugsKorea (the Republic of)
Jun 22, 2018Iacofano's Group LLCFood/CosmeticsUnited States
Jun 22, 2018PureOxyWash, Inc.DrugsUnited States
Jun 22, 2018TBN Labs, LLC.Food/CosmeticsUnited States
Jun 21, 2018Clark Seafood Co, IncFood/CosmeticsUnited States
Jun 21, 2018Nouvag AgDevicesSwitzerland
Jun 20, 2018Casa Pablo's Salsa LLCFood/CosmeticsUnited States
Jun 19, 2018ASA Universal Inc.DrugsUnited States
Jun 15, 2018Megafine Pharma (P) LimitedDrugsIndia
Jun 15, 2018Wells Enterprises, Inc.Food/CosmeticsUnited States
Jun 14, 2018Beauty Manufacturing Solutions Corp.DrugsUnited States
Jun 14, 2018Origami Surgical LLCDevicesUnited States
Jun 14, 2018Proandre SLDrugsSpain
Jun 13, 2018Invitrx Therapeutics, IncFood/CosmeticsUnited States
Jun 11, 2018Datascope Corp.DevicesUnited States
Jun 11, 2018Dolezal DairyVeterinaryUnited States
Jun 11, 2018Morski Brands, Inc.Food/CosmeticsUnited States
Jun 11, 2018Unetixs Vascular, Inc.DevicesUnited States
Jun 8, 2018Ignatius P. Godoy, M.D.BiologicsUnited States
Jun 8, 2018Laboratorios Baxter S.A.DrugsColombia
Jun 8, 2018LaMarquise Inc.Food/CosmeticsUnited States
Jun 7, 2018Avon Manufacturing (Guangzhou) Ltd.DrugsChina
Jun 7, 2018Bright Innovation LabsDrugsUnited States
Jun 6, 2018Earthworks Health LLCFood/CosmeticsUnited States
Jun 6, 2018ITG-Medev, Inc.DevicesUnited States
Jun 4, 2018Home Style Foods, Inc.Food/CosmeticsUnited States
Jun 1, 2018Ebisu Fish Inc.Food/CosmeticsUnited States
Jun 1, 2018Imu-Tek Animal Health, IncorporatedFood/CosmeticsUnited States
Jun 1, 2018Perla Del Sur Foods L.L.C.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 drugs25
21 CFR 820.100(a)Lack of or inadequate procedures24
21 CFR 117.35(a)Sanitary operations - Plant sanitation23
21 CFR 123.11(b)Sanitation monitoring documentation19
21 CFR 117.37Sanitary facilities and controls18
21 CFR 117.80(c)Process Control Measures16
21 CFR 123.6(b)No HACCP plan15
21 CFR 211.192Written record of investigation incomplete15
21 CFR 820.198(a)Lack of or inadequate complaint procedures15
21 CFR 117.20(b)Plant construction and design14

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
Jun 29, 2018Fagron Compounding Services LLC Dba Fagron Sterile ServicesDrugsLabeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as…
Jun 29, 2018Fagron Compounding Services LLC Dba Fagron Sterile ServicesDrugsLabeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as…
Jun 29, 2018LL'S MAGNETIC CLAY INCFoodThe recalled dietary supplement has the potential to contain undeclared allergens, including almonds, shellfish, milk, eggs, and peanuts.
Jun 29, 2018May Flower International Inc.FoodProduct contains undeclared milk.
Jun 28, 2018Bengard RanchFoodFDA surveillance sample found Salmonella in fresh cilantro.
Jun 28, 2018Pinnacle Food Group, LlcFoodThe recall was initiated after learning from a retail customer that a limited number of bottles were mislabeled. The product contains milk…
Jun 26, 2018World Organix, LLCDrugsMicrobial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high…
Jun 26, 2018World Organix, LLCDrugsMicrobial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high…
Jun 26, 2018World Organix, LLCDrugsMicrobial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high…
Jun 26, 2018World Organix, LLCDrugsMicrobial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high…
Jun 26, 2018World Organix, LLCDrugsMicrobial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high…
Jun 21, 2018Nectar Foods LLCFoodHoney Mama's Oregon Peppermint Cacao-Nectar Bar, 2.5 oz, is recalled due to undeclared almonds.
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Gaia Ethnobotanical LLCDrugsMicrobal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Jun 20, 2018Vyaire MedicalDevicesVyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Subglottic Suction System. The distal soft…
Jun 19, 2018Peanut Processors, Inc.FoodThe firm was notified by their customer that the product test positive for Salmonella
Jun 19, 2018Peanut Processors, Inc.FoodThe firm was notified by their customer that the product test positive for Salmonella
Jun 18, 2018Compass Health Brands (Corporate Office)DevicesA May 2015 design change in the cushion seal replacement part and accompanying elbow replacement part resulted in incompatibility of the…
Jun 14, 2018Kellogg CompanyFoodKellogg North America initiated a voluntary recall of Kellogg s Honey Smacks, 15.3 oz. and 23 oz., due to potential contamination with…
Jun 12, 2018Philips Respironics, Inc.DevicesIn 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the…
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Caito Foods Service, Inc.FoodProducts have the potential to be contaminated with Salmonella.
Jun 8, 2018Golden Star Wholesale IncFoodGolden Star Wholesale, Inc. initiated a voluntary recall of Al Reef dried apricot sour, 12 oz., due to undeclared sulfites.
Jun 6, 2018Tilgner's Alaskan SalmonFoodCanoodles (ACN) coarse ground cold smoked dehydrated shelf stable sockeye Salmon pieces are recalled due to potential for contaminated…
Jun 6, 2018Tilgner's Alaskan SalmonFoodRuby Red Sockeye Candy (ACA) cold smoked salmon is recalled due to Listeria monocytogenes
Jun 4, 2018HOSPIRA INC, LAKE FORESTDrugsPresence of Particulate Matter; Potential for particulate matter on the syringe plunger.

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.