FDA Warning Letters, 483s and Recalls: June 2024
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 |
|---|---|---|---|
| Jun 28, 2024 | Berkeley Biologics, LLC, Previously Operating As Elutia, Inc. – Orthobiologics Business Unit, Formerly Aziyo Biologics, Inc. | Center for Biologics Evaluation and Research (CBER) | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Jun 27, 2024 | Baylab USA, LLC | OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Jun 27, 2024 | Key Foods Co. Dba Key Food Services | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) |
| Jun 26, 2024 | Discover Fresh Foods, LLC | Division of Human and Animal Food Operations East III | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes |
| Jun 26, 2024 | reBom Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Jun 25, 2024 | AMCO International Manufacturing & Design, Inc. | Center for Devices and Radiological Health | Unapproved Device Violation |
| Jun 25, 2024 | Donggang Wanrui Food Co., Ltd. | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated |
| Jun 25, 2024 | Natural Ginger, Corp/Jonaus Corp | Division of Human and Animal Food Operations East IV | New Drug/Misbranded |
| Jun 25, 2024 | Sakhon Wattana Thang Chue Hah | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated |
| Jun 24, 2024 | Advance Nature Sdn Bhd | Center for Food Safety and Applied Nutrition | Low Acid Canned Food Regulation/Adulterated |
| Jun 24, 2024 | JC Finest Produce Inc | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Jun 24, 2024 | Ozempen.Com | Center for Drug Evaluation and Research | CDER | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet |
| Jun 21, 2024 | Frozen Food Development, Inc. | Division of Human and Animal Food Operations East II | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Jun 21, 2024 | Massachusetts Institute Of Technology MIT | Center for Biologics Evaluation and Research (CBER) | Bioresearch Monitoring Program/IRB |
| Jun 21, 2024 | Raya Green Coconut Co. | Center for Food Safety and Applied Nutrition | Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Jun 21, 2024 | Tamara Fruit CJSC | Center for Food Safety and Applied Nutrition | Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Jun 20, 2024 | Max Chemical Inc. | Office of Pharmaceutical Quality Operations, Division II | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Jun 20, 2024 | New Mexico Lions Sight Conservation Foundation, Inc. Dba New Mexico Lions Eye Bank | Division of Biological Products Operations II | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Jun 20, 2024 | Optikem International Inc. | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated |
| Jun 18, 2024 | Laboratorio Magnachem International | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Jun 18, 2024 | Sun Pharmaceutical Industries Limited | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Jun 17, 2024 | Bimbo Bakeries USA, Inc. | Division of Human and Animal Food Operations West IV | Food Labeling/Misbranded/False and Misleading |
| Jun 14, 2024 | AG Essence, Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Jun 14, 2024 | Vegewax Candleworx Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceutical/Adulterated |
| Jun 13, 2024 | GFA Production Xiamen Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Jun 12, 2024 | Aqualex Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Adulterated |
| Jun 12, 2024 | Landy International | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Jun 12, 2024 | PepsiCo, Inc. | Division of Human and Animal Food Operations East VI | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Jun 12, 2024 | West Coast Laboratories, Inc. | Division of Human and Animal Food Operations West V | CGMP/Dietary Supplement/Adulterated/Misbranded |
| Jun 11, 2024 | ARG Laboratories, Inc. | Office of Pharmaceutical Quality Operations, Division II | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Jun 11, 2024 | Dollar Tree Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | Adulterated Human Foods |
| Jun 10, 2024 | AKT Trading Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Jun 10, 2024 | Indiana Lions Eye Bank, Inc. Dba VisionFirst Indiana Lions Eye Bank | Division of Biological Products Operations II | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Jun 7, 2024 | Angela D. Ritter, M.D. | Center for Drug Evaluation and Research | CDER | Clinical Investigator (Sponsor) |
| Jun 5, 2024 | Neobiosis, LLC | Division of Biological Products Operations I | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Jun 5, 2024 | TCT Nutraceuticals SDN. BHD | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Jun 5, 2024 | Yahon Enterprise Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Jun 4, 2024 | Fancystage Unipessoal, LDA | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
| Jun 3, 2024 | Choo's Enterprises Ltd | Center for Food Safety and Applied Nutrition (CFSAN) | Acidified Foods/Emergency Permit Control/Adulterated |
| Jun 3, 2024 | Dalian Lingfa Food Co., Ltd. | Center for Food Safety and Applied Nutrition (CFSAN) | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Jun 3, 2024 | Top Health Manufacturing, LLC | Division of Human and Animal Food Operations West IV | CGMP/Dietary Supplement/Adulterated |
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 |
|---|---|---|---|
| Jun 28, 2024 | Fagron Compounding Services | Drugs | United States |
| Jun 27, 2024 | Huaian Mimir Electric Appliance Co. Ltd. | Devices | China |
| Jun 26, 2024 | DASADA GROUP LLC | Food/Cosmetics | United States |
| Jun 26, 2024 | Exotic Wholesale, LLC | Tobacco | United States |
| Jun 24, 2024 | J. Moniz Company, Inc. | Food/Cosmetics | United States |
| Jun 21, 2024 | Brands International Corporation | Drugs | Canada |
| Jun 21, 2024 | Carie Boyd Pharmaceuticals LLC | Drugs | United States |
| Jun 21, 2024 | Heliora Laboratories Pty Ltd. | Drugs | Australia |
| Jun 20, 2024 | Adnan M. Dahdul, M.D. | Biologics | United States |
| Jun 20, 2024 | Golden Grains Bakery Company | Food/Cosmetics | United States |
| Jun 18, 2024 | Auto-Chlor System LLC | Drugs | United States |
| Jun 17, 2024 | Eye-Novation, LLC | Devices | United States |
| Jun 14, 2024 | Dream Distro, LLC | Tobacco | United States |
| Jun 14, 2024 | Five Star Trading IL Inc. | Food/Cosmetics | United States |
| Jun 14, 2024 | Jubilant HollisterStier General Partnership | Drugs | Canada |
| Jun 14, 2024 | N A Sales Company Inc | Food/Cosmetics | United States |
| Jun 13, 2024 | Penn Herb Company, Ltd. | Food/Cosmetics | United States |
| Jun 12, 2024 | Cavevi Naturals LLC | Food/Cosmetics | United States |
| Jun 12, 2024 | Minland Of Texas, Inc. | Food/Cosmetics | United States |
| Jun 12, 2024 | Minuti Coffee LLC | Food/Cosmetics | United States |
| Jun 12, 2024 | Sperm Bank, Inc | Biologics | United States |
| Jun 11, 2024 | Peter Michael, M.D. | Drugs | United States |
| Jun 10, 2024 | A TRUE MOVE LLC | Food/Cosmetics | United States |
| Jun 7, 2024 | Chemblend Of America LLC | Drugs | United States |
| Jun 6, 2024 | Premium eJuice USA LLC | Tobacco | United States |
| Jun 5, 2024 | Integra LifeSciences Corporation | Devices | United States |
| Jun 5, 2024 | Ungerer & Co | Drugs | United States |
| Jun 3, 2024 | Phoenix Thera-Lase Systems LLC | Devices | 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 | 34 |
| 21 CFR 117.10 | Personnel | 19 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 18 |
| 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard | 17 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 15 |
| 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls | 14 |
| 21 CFR 1.505(a)(2) | Evaluation - performance, risk | 13 |
| 21 CFR 117.35(c) | Pest control | 12 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 12 |
| 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition | 10 |
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 |
|---|---|---|---|
| Jun 27, 2024 | Prophet Premium Blends, LLC | Food | Toxic levels of muscimol |
| Jun 27, 2024 | Prophet Premium Blends, LLC | Food | Toxic levels of muscimol |
| Jun 27, 2024 | Prophet Premium Blends, LLC | Food | Toxic levels of muscimol |
| Jun 27, 2024 | Prophet Premium Blends, LLC | Food | Toxic levels of muscimol |
| Jun 27, 2024 | Prophet Premium Blends, LLC | Food | Toxic levels of muscimol |
| Jun 27, 2024 | Prophet Premium Blends, LLC | Food | Toxic levels of muscimol |
| Jun 27, 2024 | Prophet Premium Blends, LLC | Food | Toxic levels of muscimol |
| Jun 27, 2024 | Prophet Premium Blends, LLC | Food | Toxic levels of muscimol |
| Jun 27, 2024 | Prophet Premium Blends, LLC | Food | Toxic levels of muscimol |
| Jun 27, 2024 | Prophet Premium Blends, LLC | Food | Toxic levels of muscimol |
| Jun 27, 2024 | Prophet Premium Blends, LLC | Food | Toxic levels of muscimol |
| Jun 27, 2024 | Prophet Premium Blends, LLC | Food | Toxic levels of muscimol |
| Jun 27, 2024 | Prophet Premium Blends, LLC | Food | Toxic levels of muscimol |
| Jun 27, 2024 | Prophet Premium Blends, LLC | Food | Toxic levels of muscimol |
| Jun 27, 2024 | Prophet Premium Blends, LLC | Food | Toxic levels of muscimol |
| Jun 27, 2024 | Prophet Premium Blends, LLC | Food | Toxic levels of muscimol |
| Jun 27, 2024 | Prophet Premium Blends, LLC | Food | Toxic levels of muscimol |
| Jun 27, 2024 | Prophet Premium Blends, LLC | Food | Toxic levels of muscimol |
| Jun 27, 2024 | Prophet Premium Blends, LLC | Food | Toxic levels of muscimol |
| Jun 27, 2024 | Prophet Premium Blends, LLC | Food | Toxic levels of muscimol |
| Jun 27, 2024 | Prophet Premium Blends, LLC | Food | Toxic levels of muscimol |
| Jun 27, 2024 | Prophet Premium Blends, LLC | Food | Toxic levels of muscimol |
| Jun 25, 2024 | Amerisource Health Services LLC | Drugs | Failed Dissolution Specifications |
| Jun 24, 2024 | Covidien | Devices | Any single affected ventilator should only be used for the 10- year labelled service life, but if longer ventilatory support is required… |
| Jun 24, 2024 | Medtronic Xomed, Inc. | Devices | Potential for false negative response on the NIM Vital Nerve Monitoring System |
| Jun 24, 2024 | Taylor Farms Northwest LLC | Food | Undeclared milk |
| Jun 24, 2024 | Taylor Farms Northwest LLC | Food | Undeclared milk |
| Jun 21, 2024 | A-S Medication Solutions LLC | Drugs | Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for… |
| Jun 21, 2024 | Foppen Paling En Zalm B.V. | Food | Potential contamination with Listeria monocytogenes |
| Jun 20, 2024 | DSD Merchandisers, Inc. | Food | Undeclared allergen; peanuts |
| Jun 20, 2024 | Solata Food LLC | Food | Product may be contaminated with Listeria monocytogenes. |
| Jun 20, 2024 | Solata Food LLC | Food | Product may be contaminated with Listeria monocytogenes. |
| Jun 20, 2024 | Solata Food LLC | Food | Product may be contaminated with Listeria monocytogenes. |
| Jun 20, 2024 | Solata Food LLC | Food | Product may be contaminated with Listeria monocytogenes. |
| Jun 20, 2024 | Solata Food LLC | Food | Product may be contaminated with Listeria monocytogenes. |
| Jun 20, 2024 | Solata Food LLC | Food | Product may be contaminated with Listeria monocytogenes. |
| Jun 19, 2024 | SUNCO & FRENCHIE LLC. | Food | Product tested positive for presence of salmonella. |
| Jun 17, 2024 | Megadyne Medical Products, Inc. | Devices | To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of… |
| Jun 17, 2024 | Megadyne Medical Products, Inc. | Devices | To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of… |
| Jun 17, 2024 | Megadyne Medical Products, Inc. | Devices | To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of… |
| Jun 13, 2024 | Totally Cool, Inc. | Food | Possible contamination with Listeria monocytogenes |
| Jun 12, 2024 | Rancho Santo Cristo, Inc | Food | Undeclared Wheat Allergen |
| Jun 12, 2024 | Rancho Santo Cristo, Inc | Food | Undeclared Wheat Allergen |
| Jun 12, 2024 | Synergetics Inc | Devices | Sterilization certificates could not be validated by the supplier |
| Jun 12, 2024 | Synergetics Inc | Devices | Sterilization certificates could not be validated by the supplier |
| Jun 12, 2024 | Synergetics Inc | Devices | Sterilization certificates could not be validated by the supplier |
| Jun 12, 2024 | Synergetics Inc | Devices | Sterilization certificates could not be validated by the supplier |
| Jun 7, 2024 | Smiths Medical ASD Inc. | Devices | There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect… |
| Jun 7, 2024 | Smiths Medical ASD Inc. | Devices | There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect… |
| Jun 7, 2024 | Smiths Medical ASD Inc. | Devices | There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect… |
| Jun 6, 2024 | GREEN LIFE FARMS | Food | Salmonella contamination |
| Jun 6, 2024 | Villa Nueva Interservices LLC | Food | Undeclared allergens: Milk |
| Jun 5, 2024 | Homeocare Laboratories, Inc. | Drugs | Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms |
| Jun 5, 2024 | Philips North America Llc | Devices | Potential for coils to heat up and harm patients (burn). |
| Jun 5, 2024 | Philips North America Llc | Devices | Potential for coils to heat up and harm patients (burn). |
| Jun 5, 2024 | Philips North America Llc | Devices | Potential for coils to heat up and harm patients (burn). |
| Jun 3, 2024 | New Seasons Market LLC | Food | Undeclared almond. |
| Jun 3, 2024 | Penn Herb Company, Ltd. | Food | Potential Salmonella contamination |
| Jun 3, 2024 | Productos La Hacienda LLC | Food | Queso fresco was found to contain Listeria monocytogenes. |
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