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FDA Warning Letters, 483s and Recalls: June 2021

FDA enforcement records dated June 2021: 29 warning letters outside tobacco (plus 11 tobacco letters), 45 OAI inspections and 77 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.

DateCompanyIssuing officeSubject
Jun 30, 2021Dry Produce Division USA LLCDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Jun 30, 2021Green City DistributionDivision of Northern Border ImportsForeign Supplier Verification Program (FSVP)
Jun 29, 2021FMT Services, LLCCenter for Food Safety and Applied Nutrition (CFSAN)Foreign Supplier Verification Program (FSVP)
Jun 29, 2021Kuiyi International Inc.Division of West Coast ImportsForeign Supplier Verification Program (FSVP)
Jun 28, 2021Fixture Display LLCCenter for Devices and Radiological HealthInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Jun 28, 2021World Packaging Solutions, LLCCenter for Devices and Radiological HealthInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Jun 25, 2021Davati Medical Supply LLCCenter for Biologics Evaluation and ResearchUnapproved and Misbranded Product Related to Influenza Virus
Jun 25, 2021Guillermo OsunaDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Jun 23, 2021Great Healthworks, Inc.Office of Human and Animal Food Operations, Division IV EastUnapproved New Drugs/Misbranded
Jun 22, 2021Pacific Center Of Health/Pacific Center Of Health & AcupunctureCenter for Drug Evaluation and ResearchUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Jun 21, 2021IDC USA INCDivision of Northeast ImportsForeign Supplier Verification Program (FSVP)
Jun 17, 2021Aquavit Pharmaceuticals, IncOffice of Medical Device and Radiological Health Division 1 – EastInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Jun 17, 2021International General Trading Corp.Division of Northeast ImportsForeign Supplier Verification Program (FSVP)
Jun 17, 2021Tianjin Bolang Science-Technology Development Co., Ltd.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Jun 15, 2021Rong Shing Trading NY Inc.Division of Northeast ImportsForeign Supplier Verification Program (FSVP)
Jun 11, 2021Novel Laboratories, Inc. D.B.A LUPINOffice of Pharmaceutical Quality Operations Division ICGMP/Finished Pharmaceuticals/Adulterated
Jun 10, 2021Innova Medical Group, Inc.Center for Devices and Radiological HealthUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Jun 10, 2021Natural Hope Herbals, LLCDivision of Human and Animal Food Operations East IINew Drug/Misbranded
Jun 9, 2021Natural Beauty Care Pty LtdCenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Jun 9, 2021Tuty Usa LLCDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Jun 8, 2021Jaramillo Spices Corp.Division of Southwest ImportsForeign Supplier Verification Program (FSVP)
Jun 8, 2021Sobh Import, Inc.Division of Northern Border ImportsForeign Supplier Verification Program (FSVP)
Jun 8, 2021STB Quarters, LLCDivision of Northern Border ImportsForeign Supplier Verification Program (FSVP)
Jun 7, 2021Amplicon Land, LLCCenter for Devices and Radiological HealthAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Jun 7, 2021Flora IncDivision of Human and Animal Food Operations West VINew Drug/Misbranded
Jun 4, 2021Zhejiang Xichen Medical Technology Co., Ltd.Center for Devices and Radiological HealthInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Jun 3, 2021DMM Vission, S.A. De C.V.Center for Drug Evaluation and ResearchFinished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Jun 2, 2021PurePurge Inc.Center for Drug Evaluation and ResearchFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Jun 1, 2021Market Of Choice, LLCOffice of Human and Animal Food Operations – West Division 6CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes

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, 2021GREEN FOOD INGREDIENTS LLCFood/CosmeticsUnited States
Jun 29, 2021INDUCTION THERAPIES LLCDevicesUnited States
Jun 28, 2021Chicago Indoor Garden, Inc.Food/CosmeticsUnited States
Jun 28, 2021Douglas TerpDevicesUnited States
Jun 28, 2021Lyden Spice CorporationFood/CosmeticsUnited States
Jun 25, 2021BN TRADING INC.Food/CosmeticsUnited States
Jun 25, 2021Greenwood Ice CreamFood/CosmeticsUnited States
Jun 25, 2021RePharm LLCDrugsUnited States
Jun 24, 2021Bea Lydecker's Naturals IncFood/CosmeticsUnited States
Jun 24, 2021Fitsum Ghebremichael AmareFood/CosmeticsUnited States
Jun 24, 2021Hubei Kangzheng Pharmaceutical Co., Ltd.DrugsChina
Jun 24, 2021Interstate Food Products, LLCFood/CosmeticsUnited States
Jun 24, 2021Invacare CorporationDevicesUnited States
Jun 24, 2021Invacare CorporationDevicesUnited States
Jun 24, 2021Invacare CorporationDevicesUnited States
Jun 24, 2021Ventura Terra Garden, Inc.Food/CosmeticsUnited States
Jun 23, 2021Professional Disposables International, Inc.DrugsUnited States
Jun 23, 2021Trekker Vapors LLPTobaccoUnited States
Jun 22, 2021Avenue Pharmacy IncDrugsUnited States
Jun 22, 2021Bella Rosa Distribution, Inc.Food/CosmeticsUnited States
Jun 22, 2021Happy Howie's, Inc.Food/CosmeticsUnited States
Jun 21, 2021Banner Smoked Fish, Inc.Food/CosmeticsUnited States
Jun 21, 2021Candy Box IncFood/CosmeticsUnited States
Jun 18, 2021Hainan Zhongyu Seafood Co., Ltd.Food/CosmeticsChina
Jun 18, 2021Inopak LtdDrugsUnited States
Jun 17, 2021Maribel's Sweets, Inc.Food/CosmeticsUnited States
Jun 16, 2021Dulces La Mejor, LLCFood/CosmeticsUnited States
Jun 15, 2021Alzar Distributions IncFood/CosmeticsUnited States
Jun 15, 2021Qualgen, LLCDrugsUnited States
Jun 15, 2021RMG Produce, LLC.Food/CosmeticsUnited States
Jun 14, 2021GREFIBiologicsUnited States
Jun 14, 2021Pharmasol CorporationVeterinaryUnited States
Jun 14, 2021Pharmasol CorporationVeterinaryUnited States
Jun 10, 2021Marquis Worldwide Specialty, IncFood/CosmeticsUnited States
Jun 9, 2021Nuvo Silver Inc.TobaccoUnited States
Jun 8, 2021CALIFORNIA TERRA GARDEN, INC.Food/CosmeticsUnited States
Jun 8, 2021Florida Cirtech IncDrugsUnited States
Jun 7, 2021Bell-More Labs, Inc.VeterinaryUnited States
Jun 7, 2021Front Door Pharmacy, LLCDrugsUnited States
Jun 7, 2021Jay Parker & Sons, LLCVeterinaryUnited States
Jun 4, 2021Custom Research Labs IncDrugsUnited States
Jun 4, 2021Homeocare Laboratories Inc.DrugsUnited States
Jun 3, 2021EXACT SCIENTIFIC SERVICES, INC.VeterinaryUnited States
Jun 3, 2021Sanitor CorporationDrugsUnited States
Jun 2, 2021Tugusto Foods, 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 1.502(a)FSVP assurances100
21 CFR 117.35(a)Sanitary operations - Plant sanitation18
21 CFR 117.35(c)Pest control14
21 CFR 1.506(a)(1)Unapproved supplier procedures - importer established12
21 CFR 1.504(a)Hazard analysis written11
21 CFR 211.22(d)Procedures not in writing, fully followed11
21 CFR 117.40Equipment and utensils - Design and maintenance10
21 CFR 312.60FD-1572, protocol compliance10
21 CFR 117.130(a)(1)Hazard Analysis - Identification of Hazard9
21 CFR 117.80(c)Manufacturing, processing, packing, holding - Controls9

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 23, 2021H & H Products CompanyFoodUndeclared allergen: FISH (anchovies) on product labeling.
Jun 22, 2021Ardil Comercial S.R.L.DrugsLabeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Jun 21, 2021Eat Gangster, LLCFoodBaking mixes contained an ingredient, tigernut flour, which was recalled because it was potentially contaminated with Salmonella.
Jun 21, 2021Prairie Wolf SpiritsDrugsHand sanitizer packaged in bottles that resemble beverage containers.
Jun 18, 2021Respironics California, LLCDevicesIt has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety…
Jun 18, 2021Respironics California, LLCDevicesIt has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety…
Jun 18, 2021Teva Pharmaceuticals USADrugsPresence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further…
Jun 16, 2021Cardinal Health 200, LLCDevicesThe current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a…
Jun 14, 2021Designed By Nature LLCFoodProducts are deficient in multiple nutrients required for infant formula, and the firms contract manufacturer does not test for…
Jun 14, 2021Designed By Nature LLCFoodProducts are deficient in multiple nutrients required for infant formula, and the firms contract manufacturer does not test for…
Jun 14, 2021Designed By Nature LLCFoodProducts are deficient in multiple nutrients required for infant formula, and the firms contract manufacturer does not test for…
Jun 14, 2021Philips Respironics, Inc.DevicesThe polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or…
Jun 14, 2021Philips Respironics, Inc.DevicesThe polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or…
Jun 14, 2021Philips Respironics, Inc.DevicesThe polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or…
Jun 14, 2021Philips Respironics, Inc.DevicesThe polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or…
Jun 14, 2021Philips Respironics, Inc.DevicesThe polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or…
Jun 14, 2021Philips Respironics, Inc.DevicesThe polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or…
Jun 4, 2021Baxter Healthcare CorporationDevicesSystem errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway…
Jun 4, 2021Eight Medical International BVDevicesThe patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
Jun 4, 2021Lakeview Farms LLCFoodPotential Listeria monocytogenes contamination in fish
Jun 4, 2021Lakeview Farms LLCFoodPotential Listeria monocytogenes contamination in fish
Jun 4, 2021Olde Thompson, LLCFoodPotential Salmonella contamination
Jun 4, 2021Tulkoff Food Products, Inc.FoodTulkoff Food Products Inc., 2229 Van Deman Street, Baltimore MD 21224 has initiated a recall of Tulkoff Spicy Kimchi Aioli, 18 fl oz Clear…
Jun 3, 2021Boston Scientific CorporationDevicesThe dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in…
Jun 3, 2021Boston Scientific CorporationDevicesThe dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in…
Jun 3, 2021Boston Scientific CorporationDevicesThe dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in…
Jun 3, 2021Boston Scientific CorporationDevicesThe dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in…
Jun 3, 2021Boston Scientific CorporationDevicesThe dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in…
Jun 3, 2021Boston Scientific CorporationDevicesThe dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in…
Jun 3, 2021Heartware, Inc.DevicesMedtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a…
Jun 3, 2021Heartware, Inc.DevicesMedtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a…
Jun 3, 2021Heartware, Inc.DevicesMedtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a…
Jun 3, 2021Heartware, Inc.DevicesMedtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a…
Jun 3, 2021Heartware, Inc.DevicesMedtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a…
Jun 3, 2021Heartware, Inc.DevicesMedtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a…
Jun 3, 2021Heartware, Inc.DevicesMedtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a…
Jun 3, 2021Heartware, Inc.DevicesMedtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a…
Jun 3, 2021Heartware, Inc.DevicesMedtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a…
Jun 3, 2021Heartware, Inc.DevicesMedtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a…
Jun 2, 2021Savor Brands LLC.FoodFarro-containing products fail to declare the major food allergen Wheat
Jun 2, 2021Savor Brands LLC.FoodFarro-containing products fail to declare the major food allergen Wheat
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 1, 2021Banner Smoked Fish Inc.FoodProduct may be contaminated with Listeria monocytogenes.

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.