FDA Warning Letters, 483s and Recalls: February 2022
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.
| Date | Company | Issuing office | Subject |
|---|---|---|---|
| Feb 28, 2022 | NeuroField, Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Feb 28, 2022 | Pet Center, Inc. | Office of Human and Animal Food Operations West Division 5 | CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Feb 28, 2022 | Sabine S. Hazan, M.D. | Center for Drug Evaluation and Research | CDER | Clinical Investigator (CI) |
| Feb 25, 2022 | Fella Group LLC | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Feb 25, 2022 | Ivermectin24H.Com | Center for Drug Evaluation and Research | CDER | Unlawful Sale of Misbranded Drugs to United States Consumers Over the Internet |
| Feb 24, 2022 | Accu Bio-Chem Laboratories | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated |
| Feb 24, 2022 | MYA International, Inc. | Office of Human and Animal Food Operations –West Division 5 | Unapproved New Drugs/Misbranded |
| Feb 23, 2022 | OC Raw Dog LLC | Office of Human and Animal Food Operations- West Division 5 | CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Feb 23, 2022 | Princess Lifestyles, LLC | Office of Human and Animal Food Operations –West Division 5 | Unapproved New Drugs/Misbranded |
| Feb 22, 2022 | My Natural Treatment | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Feb 17, 2022 | Lusys Laboratories, Inc. | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Feb 17, 2022 | Vital Health & Wellness | Office of Human and Animal Foods Operations-East V | New Drug/Misbranded |
| Feb 16, 2022 | Best Fiji Kava, Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Feb 15, 2022 | Extrapharmacy.Ru | Center for Drug Evaluation and Research | CDER | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet |
| Feb 15, 2022 | Rxshopmd.Com | Center for Drug Evaluation and Research | CDER | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet |
| Feb 11, 2022 | CardioQuip, LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated |
| Feb 11, 2022 | Cedar’S Mediterranean Foods Inc. | Office of Human and Animal Food Operations East – Division 1 | Food Labeling/Misbranded |
| Feb 11, 2022 | CytoDyn, Inc. | The Office of Prescription Drug Promotion (OPDP) | New Drug/Labeling/Misbranded |
| Feb 11, 2022 | Joy Gourmet Foods LLC | Office of Human and Animal Food Operations East Division 1 | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Feb 11, 2022 | Rena's Organic | Office of Human and Animal Food Operations East Division IV | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| Feb 10, 2022 | Toxikon Corporation/Labcorp Bedford LLC | Center for Biologics Evaluation and Research | Good Laboratory Practice (GLP) |
| Feb 9, 2022 | Bea Lydecker’S Naturals, Inc. | Division of Human and Animal Food Operations West VI | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| Feb 8, 2022 | Yusef Manufacturing Laboratories, LLC | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated |
| Feb 7, 2022 | All Good Foods, Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Feb 7, 2022 | Ulrich Farms | Division of Human and Animal Food Operations West I | Illegal Drug Residue Animal Tissue/Adulterated |
| Feb 4, 2022 | Crystal Clear Supplements | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| Feb 4, 2022 | Global LC Inc DBA Rice Chicken | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Feb 4, 2022 | Richard J. Obiso, PhD Dba Avila Herbals, LLC | Center for Drug Evaluation and Research | CDER | Clinical Investigator |
| Feb 4, 2022 | Riedstra Dairy, Ltd. | Office of Human and Animal Food Operations East Division 6 | Illegal Drug Residue Animal Tissue/Adulterated |
| Feb 3, 2022 | ECI Pharmaceuticals, LLC | Center for Drug Evaluation and Research | CDER | Failure to Register and List |
| Feb 3, 2022 | ECI Pharmaceuticals, LLC | Center for Drug Evaluation and Research | CDER | Failure to Register and List |
| Feb 3, 2022 | Pharmacy2Home/LandiCom Holding LTD | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Feb 3, 2022 | Sergio Carranza Dba MR CHESCOS | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Feb 2, 2022 | Indiana Chem-Port | Center for Drug Evaluation and Research | CDER | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Feb 2, 2022 | Smart Surgical, Inc Dba Burst Biologics | Office of Biological Products Operations – Division 2 | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Feb 2, 2022 | Sunny Creek Farm, Inc. | Division of Human and Animal Food Operations East III | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Feb 1, 2022 | New Earth Healing Essentials, LLC D/B/A 5D Full Disclosure | Center for Drug Evaluation and Research | CDER | Unapproved 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.
| Date | Facility | Product type | Country |
|---|---|---|---|
| Feb 25, 2022 | La Sonorense, Inc. | Food/Cosmetics | United States |
| Feb 25, 2022 | Mohnark Pharmaceuticals Inc | Drugs | United States |
| Feb 24, 2022 | Akralos Animal Nutrition LLC | Veterinary | United States |
| Feb 24, 2022 | Omega Alpha Pharmaceuticals | Food/Cosmetics | Canada |
| Feb 23, 2022 | Bakkavor Foods USA Inc. | Food/Cosmetics | United States |
| Feb 22, 2022 | BOLIVE INC | Food/Cosmetics | United States |
| Feb 22, 2022 | The Royal Ice Cream Company Inc. | Food/Cosmetics | United States |
| Feb 18, 2022 | Bora Pharmaceuticals Injectables Inc | Drugs | United States |
| Feb 18, 2022 | NuEra Nutraceutical Inc | Food/Cosmetics | Canada |
| Feb 18, 2022 | Sterling Pharmaceutical Services LLC | Drugs | United States |
| Feb 18, 2022 | System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh | Drugs | Germany |
| Feb 18, 2022 | Transworld International Trading Corp. | Food/Cosmetics | United States |
| Feb 17, 2022 | Export Guatemala Corp. | Food/Cosmetics | United States |
| Feb 16, 2022 | Conservas Ortiz S.A. | Food/Cosmetics | Spain |
| Feb 16, 2022 | Productos Bredy USA LLC | Food/Cosmetics | United States |
| Feb 15, 2022 | InfuTronix LLC | Devices | United States |
| Feb 15, 2022 | Ng Zheng Inc | Food/Cosmetics | United States |
| Feb 15, 2022 | Zyno Medical LLC | Devices | United States |
| Feb 11, 2022 | Dollar Tree Distribution Inc | Veterinary | United States |
| Feb 11, 2022 | Half Moon Mods LLC | Tobacco | United States |
| Feb 10, 2022 | KRISHNA TRADING LLC | Food/Cosmetics | United States |
| Feb 9, 2022 | Coastal Fresh Farms, Inc. | Food/Cosmetics | United States |
| Feb 4, 2022 | Bioiberica, SAU | Drugs | Spain |
| Feb 4, 2022 | Osteolife Biomedical I LLC | Biologics | United States |
| Feb 3, 2022 | Jam Jam Services, Inc. | Food/Cosmetics | United States |
| Feb 2, 2022 | Diaz And Son Investments, LLC | Food/Cosmetics | United States |
| Feb 1, 2022 | Fatima Brothers Inc | Food/Cosmetics | United States |
Most-cited Form 483 sections
The CFR sections FDA investigators cited most often in inspections that ended this month.
| CFR section | Observation | Citations |
|---|---|---|
| 21 CFR 1.502(a) | Develop FSVP | 59 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 14 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 13 |
| 21 CFR 117.130(a)(1) | Hazard Analysis - Identification of Hazard | 12 |
| 21 CFR 1.505(a)(2) | Evaluation - performance, risk | 12 |
| 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition | 11 |
| 21 CFR 1.506(a)(1) | Approved supplier procedures - importer established | 11 |
| 21 CFR 1.506(b) | Supplier verification - establish written procedures | 11 |
| 21 CFR 1.506(d)(1)(i) | Verification activity frequency | 11 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 11 |
Class I recalls
Class I is FDA's most serious recall class: a reasonable chance the product causes serious health problems or death.
| Date | Firm | Product type | Reason |
|---|---|---|---|
| Feb 28, 2022 | Respironics California, LLC | Devices | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the… |
| Feb 28, 2022 | Respironics California, LLC | Devices | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the… |
| Feb 28, 2022 | Respironics California, LLC | Devices | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the… |
| Feb 23, 2022 | GOLDEN MEDAL MUSHROOM INC | Food | Listeria monocytogenes |
| Feb 23, 2022 | Gourmet Kitchen, Inc. | Food | Undeclared almonds |
| Feb 23, 2022 | Gourmet Kitchen, Inc. | Food | Undeclared almonds |
| Feb 20, 2022 | Vadilal Industries USA Inc. | Food | Product may be contaminated with Salmonella |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 17, 2022 | Abbott Laboratories | Food | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… |
| Feb 16, 2022 | TCP HRB ACQUISITON LLC | Drugs | Chemical contamination: Presence of benzene |
| Feb 16, 2022 | TCP HRB ACQUISITON LLC | Drugs | Chemical contamination: Presence of benzene |
| Feb 16, 2022 | TCP HRB ACQUISITON LLC | Drugs | Chemical contamination: Presence of benzene |
| Feb 12, 2022 | Texas Star Nut And Food Co., Inc. | Food | Undeclared milk |
| Feb 12, 2022 | Texas Star Nut And Food Co., Inc. | Food | Undeclared milk |
| Feb 11, 2022 | Lehi Valley Trading Co, Inc | Food | Bags and tubs of yogurt covered raisins contained undeclared peanuts. |
| Feb 11, 2022 | Revive Rx LLC Dba Revive Rx Pharmacy | Drugs | Non-sterility; bacterial contamination identified as Paenibacillus lautus. |
| Feb 10, 2022 | Positive Health | Drugs | Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for… |
| Feb 9, 2022 | Concord Farms, Inc. | Food | California Department of Public Health sampled product and found it to contain Listeria monocytogenes. |
| Feb 9, 2022 | Walmart Stores | Drugs | Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for… |
| Feb 8, 2022 | ABC Sales 1 Inc | Drugs | Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA… |
| Feb 8, 2022 | ABC Sales 1 Inc | Drugs | Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA… |
| Feb 8, 2022 | Celebrate Today | Drugs | Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tadalafil, ingredients found in FDA approved… |
| Feb 8, 2022 | Jan Fruits, Inc. | Food | California Department of Public Health sampled product and found it to contain Listeria monocytogenes. |
| Feb 8, 2022 | Your Favorite Shop | Drugs | Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for… |
| Feb 7, 2022 | Garden-Fresh Foods, Inc. | Food | Undeclared milk. |
| Feb 7, 2022 | Mohammad Mayha | Food | Contains hidden drug ingredient |
| Feb 7, 2022 | Mohammad Mayha | Food | Contains hidden drug ingredient |
| Feb 4, 2022 | CooperSurgical, Inc | Drugs | Non-sterility |
| Feb 4, 2022 | Ev3 Inc. | Devices | The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip… |
| Feb 4, 2022 | Ev3 Inc. | Devices | The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip… |
| Feb 4, 2022 | GOLDEN MEDAL MUSHROOM INC | Food | Michigan Department of Agriculture and Rural Development sampled product and Listeria monocytogenes was detected. |
| Feb 4, 2022 | Junp Hydration LLC | Drugs | Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for… |
| Feb 3, 2022 | STAQ Pharma, Inc. | Drugs | Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with… |
| Feb 3, 2022 | STAQ Pharma, Inc. | Drugs | Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with… |
| Feb 3, 2022 | Whole Foods Market Brand 365, Llc | Food | Undeclared egg |
| Feb 1, 2022 | The Royal Ice Cream Company Inc. | Food | Product 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.