Home / Months / January 2023

FDA Warning Letters, 483s and Recalls: January 2023

FDA enforcement records dated January 2023: 37 warning letters outside tobacco (plus 11 tobacco letters), 35 OAI inspections and 24 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
Jan 30, 2023Clean Cosmetics LLCDivision of Pharmaceutical Quality Operations IVCGMP/Finished Pharmaceuticals/Adulterated
Jan 30, 2023Dr. Green Mom, LLCCenter for Food Safety and Applied Nutrition (CFSAN)Finished Pharmaceuticals/Unapproved New Drug/Misbranded
Jan 30, 2023Fei Fah Medical Manufacturing Pte. Ltd.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Jan 30, 2023Lyons Magnus, LLCDivision of Human and Animal Food Operations West ILow Acid Canned Food Regulation/Adulterated
Jan 30, 2023Monkeypox-Treatment.ComCenter for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Jan 30, 2023Noble Elements, LLCCenter for Food Safety and Applied Nutrition (CFSAN)Finished Pharmaceuticals/Unapproved New Drug/Misbranded
Jan 30, 2023Old Tiles Wallpaper, LLC DBA Old Tiles DecorCenter for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Jan 30, 2023Organic Heirloom PlantsCenter for Food Safety and Applied Nutrition (CFSAN)Finished Pharmaceuticals/Unapproved New Drug/Misbranded
Jan 27, 2023Kobayashi Healthcare International, Inc.Office of Pharmaceutical QualityCGMP/Finished Pharmaceuticals/Adulterated
Jan 27, 2023La Aldea Distributors IncDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Jan 26, 2023Desert Defense, LLCCenter for Veterinary MedicineUnapproved New Animal Drug Products
Jan 24, 2023Adept Life Science, LLCDivision of Human and Animal Food Operations East IVCGMP/Dietary Supplement/Misbranded
Jan 24, 2023American Cruise LinesDivision of Human and Animal Food Operations East VInsanitary Conditions/Adulterated
Jan 24, 2023J.M. Smucker LLCDivision of Human and Animal Food Operations East VCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Jan 23, 2023Skyless, LLCDivision of Pharmaceutical Quality Operations IICGMP/Finished Pharmaceuticals/Adulterated
Jan 23, 2023U-Can Food Trading, Inc.Division of West Coast ImportsSeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Jan 23, 2023Zing Brothers LLCDivision of Human and Animal Food Operations West IVCGMP/Dietary Supplement/Adulterated/Misbranded
Jan 20, 2023Atlantic Management Resources LTD Dba. Claire Ellen ProductsDivision of Pharmaceutical Quality Operations ICGMP/Finished Pharmaceuticals/Adulterated
Jan 20, 2023OOO “Elanders”Center for Food Safety and Applied NutritionSeafood HACCP/CGMP for Foods/Adulterated
Jan 19, 2023B & J GroupDivision of Pharmaceutical Quality Operations ICGMP/Finished Pharmaceuticals/Adulterated
Jan 19, 2023M. Fierro & Sons, LLCDivision of Human and Animal Food Operations East IICGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Jan 19, 2023Sohgave LLCDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Jan 18, 2023Buzzagogo, LLCCenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Jan 18, 2023Mohawk Laboratories Division Of NCH CorporationDivision of Pharmaceutical Quality Operations IICGMP/Drug Products/Adulterated
Jan 12, 2023First Choice Importing Inc.Division of Northeast ImportsForeign Supplier Verification Program (FSVP)
Jan 11, 2023Larkin Community Hospital Institutional Review BoardCenter for Drug Evaluation and Research | CDERBioresearch Monitoring Program/Institutional Review Board (IRB)
Jan 10, 2023HIS Enterprise Inc Dba Adam’S Secret USA, LLCCenter for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Jan 10, 2023Medical Mikes, Inc.Center for Drug Evaluation and Research | CDERUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Jan 10, 2023Purecraft LLCCenter for Drug Evaluation and Research | CDERUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Jan 9, 2023Distributor RFR, LLCCenter for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Jan 6, 2023Pharmahealthonline.ComCenter for Drug Evaluation and Research | CDERUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
Jan 5, 2023Corporate Essentials LLCDivision of Northeast ImportsForeign Supplier Verification Program (FSVP)
Jan 5, 2023PharmaCannaCenter for Drug Evaluation and Research | CDERUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Jan 5, 2023Vanlaw Food Products, IncDivision of Human and Animal Food Operations West VFood Labeling/Misbranded
Jan 4, 2023Compass Logistics, LLCDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Jan 3, 2023Golden Bridge Gourmet, Inc. DBA Golden Bridge EnterprisesDivision of West Coast ImportsForeign Supplier Verification Program (FSVP)
Jan 3, 2023Select Produce LLCDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)

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
Jan 31, 2023Kepix, Corp.Food/CosmeticsUnited States
Jan 31, 2023Olympic Eel & Salmon Industries SAFood/CosmeticsGreece
Jan 30, 2023Antonio E. Blanco, M.D.DrugsUnited States
Jan 30, 2023Suther Feeds, Inc.VeterinaryUnited States
Jan 27, 2023Baxter Pharmaceuticals India Pvt LtdDrugsIndia
Jan 27, 2023Fanta SeafoodsFood/CosmeticsGuyana
Jan 27, 2023MEDGEL PRIVATE LIMITEDDrugsIndia
Jan 26, 2023Lopez Gonzalez Santana CorporationFood/CosmeticsUnited States
Jan 26, 2023Marumo Co., Ltd.Food/CosmeticsJapan
Jan 26, 2023PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.DevicesNetherlands
Jan 25, 2023Breezesmokes LLCTobaccoUnited States
Jan 24, 2023Amor Nino Foods IncFood/CosmeticsUnited States
Jan 24, 2023Avlon Industries, IncDrugsUnited States
Jan 23, 2023Luis J. Pena-Hernandez, M.D.DrugsUnited States
Jan 20, 2023Anicare Pharmaceuticals Pvt Ltd.DrugsIndia
Jan 20, 2023Colorado Center For Reproductive Medicine, LCBiologicsUnited States
Jan 20, 2023Dara Food LLCFood/CosmeticsUnited States
Jan 20, 2023LXR BiotechDrugsUnited States
Jan 19, 2023Advanced Medical Design Co., Ltd.DevicesTaiwan
Jan 19, 2023Cornerstone Laboratories LLCDrugsUnited States
Jan 19, 2023Future Diagnostics Solutions B.V.DevicesNetherlands
Jan 19, 2023I.T.S. GmbHDevicesAustria
Jan 19, 2023Source-Omega LLCFood/CosmeticsUnited States
Jan 18, 2023Cronus Pharma Specialities India Pvt LtdVeterinaryIndia
Jan 18, 2023Living Foods LLCFood/CosmeticsUnited States
Jan 17, 2023STC INDIA PVT LTD.Food/CosmeticsIndia
Jan 13, 2023Future Foam, Inc.DrugsUnited States
Jan 13, 2023Osmosis, LLCFood/CosmeticsUnited States
Jan 13, 2023Victory Trading Company Inc.Food/CosmeticsUnited States
Jan 12, 2023Jamol Laboratories, Inc.DrugsUnited States
Jan 12, 2023Midwest Sterilization CorporationDevicesUnited States
Jan 12, 2023Still Water Dairy, LLCVeterinaryUnited States
Jan 10, 2023Bret R. Rutherford, M.D.DrugsUnited States
Jan 9, 2023Mead Johnson & Company, LLCFood/CosmeticsUnited States
Jan 6, 2023Midwest Sprouts, LLCFood/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 FSVP55
21 CFR 820.100(a)Lack of or inadequate procedures21
21 CFR 117.35(a)Sanitary operations - Plant sanitation20
21 CFR 123.6(c)(1)Food safety hazards16
21 CFR 820.198(a)Lack of or inadequate complaint procedures16
21 CFR 117.35(c)Pest control14
21 CFR 117.40Equipment and utensils - Design and maintenance13
21 CFR 211.192Written record of investigation incomplete13
21 CFR 117.135(a)(1)Sanitation preventive controls - Implement11
21 CFR 123.6(c)(2)Critical control points11

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
Jan 30, 2023DAISO CALIFORNIA WAREHOUSEFoodProduct was found to contain the allergen of soy that was not listed on the ingredient label.
Jan 30, 2023Epic BakingFoodFirm did not list sub-ingredients. Firm did not list yellow cake and it's ingredients. Undeclared Y5, R40, soy flour, soy lecithin and…
Jan 30, 2023Global Pharma Healthcare Private LimitedDrugsNon-Sterility: FDA analysis found unopened products to have bacterial contamination.
Jan 30, 2023Global Pharma Healthcare Private LimitedDrugsNon-Sterility: FDA analysis found unopened products to have bacterial contamination.
Jan 28, 2023LLK TRADING INCFoodXin Ao International Group Corp, 601 E. Linden Ave Linden NJ 07036is initiating a recall of Enoki Mushroom, 200g, Plastic Bag, 25 bags per…
Jan 27, 2023SOVOS BRANDS INTERMEDIATE, INC.FoodThe firm has initiated a recall of Rao's Made for Home Slow Simmered Soup, labeled as Chicken & Gnocchi but containing vegetable…
Jan 25, 2023Baxter Healthcare CorporationDevicesThere is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected…
Jan 25, 2023Baxter Healthcare CorporationDevicesThere is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected…
Jan 25, 2023Baxter Healthcare CorporationDevicesThere is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected…
Jan 25, 2023Baxter Healthcare CorporationDevicesThere is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected…
Jan 23, 2023Draeger Medical, Inc.DevicesThe magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and…
Jan 23, 2023Draeger Medical, Inc.DevicesThe magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and…
Jan 16, 2023Taylor Farms Maryland, Inc.FoodUndeclared eggs and milk in salad
Jan 13, 2023UTOPIA FOODS INCFoodProduct may be contaminated with Listeria monocytogenes.
Jan 10, 2023DAISO CALIFORNIA WAREHOUSEFoodProducts contains almonds that were not listed on the ingredient label.
Jan 10, 2023DAISO CALIFORNIA WAREHOUSEFoodProduct contains milk and shellfish that are not listed on the ingredient label.
Jan 10, 2023DAISO CALIFORNIA WAREHOUSEFoodProduct contains soy and peanuts that are not listed on the ingredient label.
Jan 10, 2023DAISO CALIFORNIA WAREHOUSEFoodProduct contains almonds that are not listed on the ingredient label.
Jan 10, 2023DAISO CALIFORNIA WAREHOUSEFoodProduct contains almonds that are not listed on the ingredient label.
Jan 10, 2023DAISO CALIFORNIA WAREHOUSEFoodProduct contains soy and sesame that are not listed on the ingredient label.
Jan 10, 2023DAISO CALIFORNIA WAREHOUSEFoodProduct contains peanuts that are not listed on the ingredient label.
Jan 10, 2023DAISO CALIFORNIA WAREHOUSEFoodProduct contains almonds and peanuts that were not listed on the ingredient label.
Jan 10, 2023DAISO CALIFORNIA WAREHOUSEFoodProduct contains peanuts that are not listed on the ingredient label.
Jan 9, 2023THE ISH COMPANYFoodundeclared soy proteins

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.