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FDA Warning Letters, 483s and Recalls: May 2024

FDA enforcement records dated May 2024: 26 warning letters outside tobacco (plus 3 tobacco letters), 53 OAI inspections and 143 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
May 31, 2024Chang And Son Enterprises, Inc.Division of Human and Animal Food Operations East ICGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
May 31, 2024Cosmetic Solutions, LLCDivision of Pharmaceutical Quality Operations IICGMP/Finished Pharmaceuticals/Adulterated
May 31, 2024Fuyang Fuchunjiang Canned Food Co., Ltd.Center for Food Safety and Applied Nutrition (CFSAN)Low Acid Canned Food Regulation/Adulterated
May 31, 2024Rongcheng Jiayuan Food Co., LtdCenter for Food Safety and Applied Nutrition (CFSAN)Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
May 29, 2024Big Island Candies, Inc.Division of Human and Animal Food Operations West VCGMP Food Labeling/Misbranded/Adulterated
May 29, 2024Konrad Rejdak, M.D., Ph.D.Center for Biologics Evaluation and Research (CBER)Bioresearch Monitoring Program/IRB
May 28, 2024J&R Produce, Inc.Division of Southwest ImportsForeign Supplier Verification Program (FSVP)
May 22, 2024Art Of Beauty Company, Inc.Division of Pharmaceutical Quality Operations IIICGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
May 21, 2024Midwest Foods, LLCDivision of Human and Animal Food Operations West IIAcidified Foods/Prepared Packed or Held Under Insanitary Conditions
May 16, 2024All Things Bunnies, Inc.Center for Veterinary MedicineUnapproved New Animal Drug/Adulterated
May 16, 2024Linessa Farms, LLCCenter for Veterinary MedicineUnapproved New Animal Drug/Adulterated
May 16, 2024McClure’S Lancaster Old Fashioned, LLCDivision of Human and Animal Food Operations East IICGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
May 16, 2024Swity D.O.O.Center for Food Safety and Applied NutritionAcidified Foods/Emergency Permit Control/Adulterated/Misbranded
May 16, 2024Toltrazuril ShopCenter for Veterinary MedicineUnapproved New Animal Drug/Adulterated
May 16, 2024Totaltoltrazuril.ComCenter for Veterinary MedicineUnapproved New Animal Drug/Adulterated
May 14, 2024Genpro Imports & Export Inc.Division of West Coast ImportsForeign Supplier Verification Program (FSVP)
May 13, 2024Aruba Aloe Balm N.V.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated/Misbranded
May 13, 2024Golden Shrimp Seafood Joint Stock CompanyCenter for Food Safety and Applied NutritionSeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
May 9, 2024Biomic Sciences, LLC Dba ION Intelligence Of NatureDivision of Human and Animal Food Operations East IICGMP/Finished Pharmaceuticals/Adulterated
May 9, 2024Cue Health, Inc.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
May 5, 2024Amin Trading Agency LLCDivision of Northeast ImportsForeign Supplier Verification Program (FSVP)
May 3, 2024Natuzen Co., Ltd.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
May 2, 2024Kevin R. Bender, M.D./DBC Research CorporationCenter for Drug Evaluation and Research | CDERClinical Investigator
May 1, 2024Baja Best Distributing, Inc.Division of Southwest ImportsForeign Supplier Verification Program (FSVP)
May 1, 2024Mariscos Perla Mar S. De R.L.Center for Food Safety and Applied NutritionSeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
May 1, 2024Ogura Shokuhin Co. Ltd.Center for Food Safety and Applied NutritionSeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions

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, 2024Diora Kimya Sanayi Ve Ticaret Limited SirketiDrugsTurkey
May 31, 2024Irvington Seafood, Inc.Food/CosmeticsUnited States
May 31, 2024Knickerbocker 365 Inc.Food/CosmeticsUnited States
May 31, 2024Naturavit IncFood/CosmeticsUnited States
May 31, 2024Robbins Instruments, LLCDevicesUnited States
May 31, 2024Srikem Laboratories Private Ltd.DrugsIndia
May 29, 2024OPS International IncDrugsUnited States
May 27, 2024DALAI BIOTECH COMPANY LTDFood/CosmeticsTaiwan
May 27, 2024Miyajima Shoyu Co., Ltd.Food/CosmeticsJapan
May 24, 2024Dr. Gretel Trullenque, DODrugsUnited States
May 24, 2024Elementis SRL, Inc.DrugsUnited States
May 24, 2024EUROSIREL S.P.ADrugsItaly
May 24, 2024Originitalia SRLDrugsItaly
May 24, 2024Shalini Iyengar, MBBSBiologicsUnited Kingdom
May 23, 2024CLUNAS SP. Z O.O. ULDevicesPoland
May 23, 2024Micro-X Ltd.DevicesAustralia
May 22, 2024American CryoStem CorporationBiologicsUnited States
May 22, 2024CareFusion 303, Inc.DevicesUnited States
May 22, 2024Prairie FoodsFood/CosmeticsUnited States
May 22, 2024ProTab LaboratoriesFood/CosmeticsUnited States
May 22, 2024Thorn BioScience LLCVeterinaryUnited States
May 22, 2024Tom's Of Maine, Inc.DrugsUnited States
May 21, 2024BACALAO GIRALDO, S.L.U.Food/CosmeticsSpain
May 21, 2024Iowa Egg Company, Inc.Food/CosmeticsUnited States
May 20, 2024New Life Medical Services, LLCBiologicsUnited States
May 17, 2024Analytical Food Laboratories Inc.DrugsUnited States
May 17, 2024Calyx Chemicals & Pharmaceuticals LimitedDrugsIndia
May 17, 2024FCC Horiuchi Co., Ltd.Food/CosmeticsJapan
May 17, 2024Good Karma Cigar LLCTobaccoUnited States
May 17, 2024Lewis Sausage Company, Inc.VeterinaryUnited States
May 16, 2024Coastal E-Liquid Laboratory, LLCTobaccoUnited States
May 16, 2024Diamond Chemical Co. Inc.DrugsUnited States
May 16, 2024Dr Ma's Laboratories, Inc.Food/CosmeticsCanada
May 16, 2024Fres Co, LLCFood/CosmeticsUnited States
May 16, 2024Ya Ya Foods USA LLCFood/CosmeticsUnited States
May 15, 2024Aurobindo Pharma USA IncDrugsUnited States
May 15, 2024Brew City Juice LLCTobaccoUnited States
May 15, 2024Feed Blenders,Inc.VeterinaryUnited States
May 15, 2024Fong Kee Tofu Co., Inc.Food/CosmeticsUnited States
May 15, 2024Loyd Sanabria HernandezFood/CosmeticsUnited States
May 14, 2024Unexo Life Sciences Private LimitedDrugsIndia
May 13, 2024VidasoyFood/CosmeticsUnited States
May 10, 2024Clean Solutions LLCDrugsUnited States
May 10, 2024MedOffice Saglik Endustri Anonim SirketiDrugsTurkey
May 9, 2024RIO BIOFARMA BRASIL LTDADevicesBrazil
May 8, 2024Neilmed Pharmaceuticals IncDrugsUnited States
May 3, 2024American Behavioral Research Institute, LLCDrugsUnited States
May 3, 2024Applied Therapeutics, Inc.DrugsUnited States
May 3, 2024Best Buy Bones Inc.VeterinaryUnited States
May 3, 2024EUGIA Pharma Specialities LimitedDrugsIndia
May 3, 2024Wakker Dairy Farm, LLCVeterinaryUnited States
May 2, 2024LS Promotions Inc.DrugsUnited States
May 1, 2024INDIAN GROCERIES AND SPICES INCFood/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)Develop FSVP38
21 CFR 117.35(a)Sanitary operations - Plant sanitation25
21 CFR 117.135(a)(1)Sanitation preventive controls - Implement23
21 CFR 820.100(a)Lack of or inadequate procedures22
21 CFR 117.130(a)(1)Hazard analysis - Identification of hazard21
21 CFR 117.80(c)Manufacturing, processing, packing, holding - Controls18
21 CFR 211.100(a)Absence of Written Procedures18
21 CFR 117.35(c)Pest control16
21 CFR 123.11(b)Sanitation monitoring documentation15
21 CFR 820.198(a)Lack of or inadequate complaint procedures15

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 31, 2024Abiomed, Inc.DevicesNine (9) Impella CP pumps failed inspection and were inadvertently released.
May 31, 2024Smiths Medical ASD Inc.DevicesThere is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150…
May 31, 2024Smiths Medical ASD Inc.DevicesThere is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150…
May 31, 2024Smiths Medical ASD Inc.DevicesSmiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300…
May 31, 2024Smiths Medical ASD Inc.DevicesSmiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300…
May 30, 2024Baxter Healthcare CorporationDevicesPotential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure…
May 30, 2024Baxter Healthcare CorporationDevicesPotential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure…
May 30, 2024Glenmark Pharmaceuticals Inc., USADrugsFailed Dissolution Specifications
May 30, 2024Glenmark Pharmaceuticals Inc., USADrugsFailed Dissolution Specifications
May 29, 2024Baxter Healthcare CorporationDevicesPotential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 29, 2024Smiths Medical ASD Inc.DevicesSmiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products…
May 28, 2024Sagent PharmaceuticalsDrugsPresence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
May 28, 2024Sagent PharmaceuticalsDrugsPresence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
May 28, 2024U.B.C. Food Distributors INC.FoodPotential Salmonella contamination
May 24, 2024AMB FOODS INCFoodProducts contain undeclared wheat.
May 24, 2024AMB FOODS INCFoodProducts contain undeclared wheat.
May 24, 2024Dairy Manufacturers, IncFoodThe firm has not submitted the required premarket notification, parents and caregivers should understand that the products have not been…
May 24, 2024Dairy Manufacturers, IncFoodThe firm has not submitted the required premarket notification, parents and caregivers should understand that the products have not been…
May 24, 2024Dairy Manufacturers, IncFoodThe firm has not submitted the required premarket notification, parents and caregivers should understand that the products have not been…
May 24, 2024SYNCHRONICITY SPA INC, DBA SUNTEDrugsMicrobial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
May 23, 2024Fresh Start Produce Sales, Inc.FoodDue to Salmonella in Cucumbers
May 17, 2024EL CANGREJO GUAYACO LLCFoodThe product is positive for Listeria monocytogenes
May 17, 2024Irvington Seafood, Inc. Dba ISF, Inc.FoodListeria monocytogenes identified in finished product testing.
May 17, 2024Irvington Seafood, Inc. Dba ISF, Inc.FoodListeria monocytogenes identified in finished product testing.
May 17, 2024Irvington Seafood, Inc. Dba ISF, Inc.FoodListeria monocytogenes identified in finished product testing.
May 17, 2024Irvington Seafood, Inc. Dba ISF, Inc.FoodListeria monocytogenes identified in finished product testing.
May 16, 2024Andersen & Sons Shelling, Inc.FoodListeria monocytogenes contamination
May 16, 2024Inspire Medical Systems Inc.DevicesThere is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and…
May 15, 2024County Road Seafood, LLCFoodProduct contains (allergen) undeclared egg.
May 15, 2024Hamilton Medical AGDevicesVentilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this…
May 14, 2024H & U Inc. Dba Sun NoodleFoodUndeclared egg
May 10, 2024Global Commodities IncFoodProduct contains elevated levels of undeclared sulfites.
May 10, 2024Healthwest Minerals, Inc. Dba Mt. Capra ProductsFoodThe Goat Milk Formula Recipe Kit has been sold and marketed as infant formula, but product has not submitted to FDA the premarket…
May 8, 2024BonBon NYC LLC.FoodProduct may contain undeclared almonds, wheat, and nuts.
May 8, 2024Megadyne Medical Products, Inc.DevicesReports of patient burns.
May 8, 2024Thoratec Corp.DevicesSystem monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place…
May 7, 2024ICU Medical IncDevicesDue to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery…
May 7, 2024ICU Medical IncDevicesDue to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery…
May 7, 2024ICU Medical IncDevicesDue to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery…
May 6, 2024Hy-Vee Stores IncFoodPotential Salmonella contamination
May 6, 2024WESTERN MIXERS PRODUCE & NUTS, IFoodPotential Salmonella contamination.
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination
May 3, 2024Danisco USA Inc.FoodPotential Salmonella Contamination

Showing the latest 100 of 143.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.