Home / Months / December 2021

FDA Warning Letters, 483s and Recalls: December 2021

FDA enforcement records dated December 2021: 32 warning letters outside tobacco (plus 33 tobacco letters), 29 OAI inspections and 198 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.

DateCompanyIssuing officeSubject
Dec 29, 2021Genesis Partnership Company SACenter for Drug Evaluation and Research | CDERDrug Product/Misbranded
Dec 29, 2021Health Plus Inc.Division of Pharmaceutical Quality Operations IVCGMP/Finished Pharmaceuticals/Adulterated
Dec 29, 2021Varigard, LLCCenter for Drug Evaluation and Research | CDERUnapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)
Dec 23, 2021Aroma Imports, Inc.Division of Northern Border ImportsForeign Supplier Verification Program (FSVP)
Dec 23, 2021Euphrates Foods, LLC Dba Labeeb Alani Inc.Division of Northern Border ImportsForeign Supplier Verification Program (FSVP)
Dec 21, 2021Sunstar Americas, Inc.Office of Medical Devices and Radiological Health Operations Div. 2 CentralCGMP/QSR/Medical Devices/Adulterated
Dec 21, 2021Vasyl Melnyk, M.D.Center for Drug Evaluation and Research | CDERBioresearch Monitoring Program/IRB
Dec 20, 2021Frozen Wheels, LLCDivision of Pharmaceutical Quality Operations IIDrug Product/Adulterated
Dec 20, 2021Teahouse Tapioca And Tea Inc.Division of Southwest ImportsForeign Supplier Verification Program (FSVP)
Dec 17, 2021Greenwood Ice Cream, LLCOffice of Human and Animal Food Operations – East Division 3CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Dec 15, 2021Cooper InstituteOffice of Biological Products Operations – Division 2Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Dec 15, 2021International Golden Foods IncOffice of Human and Animal Food Operations East-VICGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Dec 15, 2021Maquiladora Miniara SA De CVCenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Dec 15, 2021Spartan Chemical Company, Inc.Division of Pharmaceutical Quality Operations IIICGMP/Finished Pharmaceuticals/Adulterated
Dec 14, 2021Eli’S Manhattan Warehouse, Inc.Division of Northeast ImportsForeign Supplier Verification Program (FSVP)
Dec 14, 2021Guangdong Kemei Pharmaceutical Technology Co. Ltd.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Dec 13, 2021The Famous Lartigue SeafoodOffice of Human and Animal Food Operations-East 5Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Dec 9, 2021Ding Tea BalboaDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Dec 9, 2021Medtronic, Inc.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Dec 9, 2021Wholly Liquid Nutritional Supplements LLCOffice of Human and Animal Food Operations East – Division 1New Drug/Misbranded
Dec 8, 2021VHRK Food Inc.Division of Northern Border ImportsForeign Supplier Verification Program (FSVP)
Dec 7, 2021Guangzhou Shiruoni Cosmetics Co., LtdCenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated/Misbranded
Dec 7, 2021OFP Ingredients LLCDivision of Human and Animal Food Operations West ICGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Dec 7, 2021Western Herb Products, Inc.Office of Human and Animal Food Operations – West Division 6CGMP/Dietary Supplement/Adulterated/Misbranded
Dec 6, 2021Tropic Trading Co.Division of Southwest ImportsForeign Supplier Verification Program (FSVP)
Dec 1, 2021DermaCare Biosciences, LTD.Center for Devices and Radiological HealthAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Dec 1, 2021Eagle Energy USA, Inc.Center for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded
Dec 1, 2021NV Nutrition, LLCCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded
Dec 1, 2021Sabra Dipping Company, LLCDivision of Human and Animal Food Operations East IICGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Dec 1, 2021VitaCig, Inc.Center for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded
Dec 1, 2021Vitamin Vape, Inc.Center for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded
Dec 1, 2021VitaStik, Inc.Center for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded

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
Dec 30, 2021DON'T RUN OUT, INCFood/CosmeticsUnited States
Dec 23, 2021FELLA GROUP LLCFood/CosmeticsUnited States
Dec 22, 2021A.N.N. Imports LLCFood/CosmeticsUnited States
Dec 20, 2021Dairy Feeds IncVeterinaryUnited States
Dec 20, 2021Vitti Labs, LLCBiologicsUnited States
Dec 17, 2021Compound Preferred LLCDrugsUnited States
Dec 17, 2021El Dorado Imports IncFood/CosmeticsUnited States
Dec 16, 2021Ozona Organics LLCFood/CosmeticsUnited States
Dec 16, 2021Valley View Milling LLCVeterinaryUnited States
Dec 15, 2021DuPont Nutrition USA, IncDrugsUnited States
Dec 15, 2021Hainan Golden Spring Foods Co. Ltd.Food/CosmeticsChina
Dec 15, 2021JP Ventures LLCTobaccoUnited States
Dec 14, 2021Bhan Kanom Thai Inc.Food/CosmeticsUnited States
Dec 14, 2021CRAVING VAPOR INDUSTRIESTobaccoUnited States
Dec 13, 2021Daniel Fred Goodman, M.D.DrugsUnited States
Dec 10, 2021C R Supplements LLCFood/CosmeticsUnited States
Dec 10, 2021Yippee Farms, LLCVeterinaryUnited States
Dec 9, 2021Genlabs CorporationDrugsUnited States
Dec 9, 2021J.B Evans Farms IncVeterinaryUnited States
Dec 8, 2021GUILLERMO OSUNAFood/CosmeticsUnited States
Dec 8, 2021Iacofano's Group LLCFood/CosmeticsUnited States
Dec 7, 2021Aurolife Pharma, LLCDrugsUnited States
Dec 7, 2021MCACO, LTDFood/CosmeticsUnited States
Dec 7, 2021SCO Koladen LLCFood/CosmeticsUnited States
Dec 6, 2021Allure Foods LlcFood/CosmeticsUnited States
Dec 6, 2021NutraCap Holdings LLCFood/CosmeticsUnited States
Dec 2, 2021Calvin Scott & Company, Inc.DrugsUnited States
Dec 2, 2021GW FOOD USA INCFood/CosmeticsUnited States
Dec 2, 2021Markfed CanneriesFood/CosmeticsIndia

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 assurances53
21 CFR 111.70(e)Specifications - identity, purity, strength, composition13
21 CFR 117.80(c)Manufacturing, processing, packing, holding - Controls13
21 CFR 117.35(a)Sanitary operations - Plant sanitation11
21 CFR 117.35(c)Pest control10
21 CFR 820.100(a)Lack of or inadequate procedures10
21 CFR 117.130(a)(1)Hazard Analysis - Identification of Hazard9
21 CFR 117.4Training of employees and records9
21 CFR 123.6(b)No HACCP plan9
21 CFR 211.22(d)Procedures not in writing, fully followed9

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
Dec 29, 2021Baxter Healthcare CorporationDevicesThere is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as…
Dec 29, 2021Baxter Healthcare CorporationDevicesThere is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as…
Dec 28, 2021CELLTRION USA INCDevicesThe affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kits were erroneously…
Dec 27, 2021NutriCrafters LLCFoodFirm repacked and distributed Medium Chain Triglycerides (MCT) powder that is now under recall by supplier.
Dec 27, 2021Sandridge Food CorporationFoodUndeclared Egg Allergen
Dec 26, 2021Joseph Seviroli Inc.FoodMay contain undeclared milk
Dec 23, 2021MOOR HERBSFoodProduct is marketed as an infant formula but the required pre-market infant formula notification for this product has not been submitted to…
Dec 23, 2021Nutralliance IncFoodUndeclared allergen; milk.
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Dole Fresh Vegetables IncFoodPotential Listeria monocytogenes
Dec 22, 2021Empowered Diagnostics LLCDevicesCOVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or…
Dec 22, 2021Empowered Diagnostics LLCDevicesCOVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or…
Dec 22, 2021Philips Respironics, Inc.DevicesPhilips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used…
Dec 22, 2021Philips Respironics, Inc.DevicesPhilips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used…
Dec 21, 2021D & M Smoked Fish, Inc.FoodMay be contaminated with Listeria monocytogenes
Dec 21, 2021Lohxa, LLCDrugsMicrobial Contamination of Non-Sterile Product
Dec 20, 2021DREAM POPSFoodUndeclared allergen; milk
Dec 20, 2021DREAM POPSFoodUndeclared allergen; milk
Dec 20, 2021DREAM POPSFoodUndeclared allergen; milk
Dec 20, 2021DREAM POPSFoodUndeclared allergen; milk
Dec 20, 2021Vyaire MedicalDevicesPotential cessation in ventilation can occur under specific conditions.
Dec 18, 2021Fresh Express Inc (Div Of Chiquita Brands)Foodpotential to be contaminated with Listeria monocytogenes
Dec 18, 2021Fresh Express Inc (Div Of Chiquita Brands)Foodpotential to be contaminated with Listeria monocytogenes
Dec 18, 2021Fresh Express Inc (Div Of Chiquita Brands)Foodpotential to be contaminated with Listeria monocytogenes
Dec 18, 2021Fresh Express Inc (Div Of Chiquita Brands)Foodpotential to be contaminated with Listeria monocytogenes
Dec 18, 2021Fresh Express Inc (Div Of Chiquita Brands)Foodpotential to be contaminated with Listeria monocytogenes

Showing the latest 100 of 198.

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.