FDA Warning Letters, 483s and Recalls: August 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 |
|---|---|---|---|
| Aug 30, 2024 | 100Misterios, LDA | Center for Food Safety and Applied Nutrition | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Aug 30, 2024 | Kyokuyo Global Seafoods Co. LTD. | Center for Food Safety and Applied Nutrition | Seafood HACCP/CGMP for Foods/Adulterated |
| Aug 30, 2024 | Procesadora Marina De La Costa Oriental Del Lago C.A. | Center for Food Safety and Applied Nutrition | Seafood HACCP/CGMP for Foods/Adulterated |
| Aug 30, 2024 | Root Bioscience Brands, LLC Dba Naternal | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Aug 30, 2024 | Wissner-Bosserhoff GmbH | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Aug 29, 2024 | Orean Personal Care Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Aug 29, 2024 | Zydus Lifesciences Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Aug 28, 2024 | Barohup Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Aug 27, 2024 | Everymarket Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Aug 27, 2024 | MexHealth LLC D/B/A Al Natural E-Shop | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Aug 27, 2024 | SoloVital | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Aug 22, 2024 | California Veterinary Supply | Center for Veterinary Medicine | Unapproved Medically Important Antimicrobials Marketed for Use in Non-food Minor Species |
| Aug 20, 2024 | AnuMed International, LLC | Center for Drug Evaluation and Research (CDER) | Finished Pharmaceutical/Unapproved New Drug/Adulterated/Misbranded |
| Aug 20, 2024 | Julio R. Flamini, M.D./Clinical Integrative Research Center Of Atlanta | Center for Drug Evaluation and Research (CDER) | Clinical Investigator |
| Aug 20, 2024 | Mother Stem Institute, Corp. | Center for Biologics Evaluation and Research (CBER) | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Aug 19, 2024 | Kaylaan LLC | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated |
| Aug 17, 2024 | HH Fresh Trading Corp | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Aug 16, 2024 | Regenerative Processing Plant, LLC | Center for Biologics Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated |
| Aug 15, 2024 | Accupack Midwest, Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated |
| Aug 15, 2024 | Eugia Pharma Specialities Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Aug 15, 2024 | Intercos Europe S.P.A | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Aug 15, 2024 | Media Networks Sydney Pty Limited | Center for Drug Evaluation and Research (CDER) | Failure to Register and List |
| Aug 14, 2024 | Graceleigh, Inc. Dba Sammy’S Milk | Division of Human and Animal Food Operations West V | Food Labeling/Misbranded |
| Aug 14, 2024 | Manabi Export Panama S.A. | Center for Food Safety and Applied Nutrition | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Aug 13, 2024 | Agustson A/S | Center for Food Safety and Applied Nutrition | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Aug 13, 2024 | Agustson A/S | Center for Food Safety and Applied Nutrition | Acidified Foods/Emergency Permit Control/Adulterated |
| Aug 13, 2024 | NRS Enterprises, Inc. D/B/A Sunflour Bakery | Division of Human and Animal Food Operations West V | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Aug 13, 2024 | Optikem International, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Aug 13, 2024 | Restorative Botanicals, LLC | Division of Human and Animal Food Operations West IV | CGMP/Dietary Supplement/Adulterated |
| Aug 13, 2024 | Waiakea Bottling Inc. | Division of Human and Animal Food Operations West V | CGMP/Processing & Bottling of Bottled Drinking Water Regulations/Adulterated |
| Aug 12, 2024 | Greco Gas, Inc. | Office of Pharmaceutical Quality | CGMP/Finished Pharmaceuticals/Adulterated |
| Aug 9, 2024 | AUSTROFOOD S.A.S. | Center for Food Safety and Applied Nutrition (CFSAN) | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Aug 8, 2024 | Mena Food Group, LLC | Office of Regulatory Affairs | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions |
| Aug 8, 2024 | Shenzhen Moyeah Intelligent Life Technology Co. | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Aug 7, 2024 | Adventure Innovations LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Aug 7, 2024 | J. Moniz Company Inc. | Division of Northeast Imports | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Aug 7, 2024 | LEEL Tech | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Aug 7, 2024 | Natures Pillows, Inc. And Top Dog Direct, LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Aug 6, 2024 | Wittman Pharma, Inc. | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated |
| Aug 5, 2024 | Anglo Freight USA Inc. | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) |
| Aug 5, 2024 | LS Promotions Inc. | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated |
| Aug 1, 2024 | Dasada Group LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Aug 1, 2024 | Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/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 |
|---|---|---|---|
| Aug 30, 2024 | Acino Products, LLC | Drugs | United States |
| Aug 30, 2024 | Huangshi Hygienic Material Medicine Co., Ltd. | Drugs | China |
| Aug 30, 2024 | Meditco, Inc. D.B.A. Phoenicia Specialty Foods | Food/Cosmetics | United States |
| Aug 30, 2024 | Profounda Inc | Drugs | United States |
| Aug 30, 2024 | Shantou S.E.Z Baojie Industry Co., Ltd. | Drugs | China |
| Aug 30, 2024 | Voehlganic Farm, LLC | Food/Cosmetics | United States |
| Aug 29, 2024 | Dextrum Laboratories | Drugs | United States |
| Aug 29, 2024 | MIDWEST GOODS INC. | Tobacco | United States |
| Aug 28, 2024 | Empower Clinic Services LLC | Drugs | United States |
| Aug 27, 2024 | Kingdom Creamery Of Vermont LLC | Food/Cosmetics | United States |
| Aug 26, 2024 | Elite Brothers, LLC | Tobacco | United States |
| Aug 26, 2024 | ITC Global Trading, Inc. | Food/Cosmetics | United States |
| Aug 23, 2024 | Baldwin Richardson Foods Pennsauken, LLC | Food/Cosmetics | United States |
| Aug 23, 2024 | Countryside Feed, LLC | Veterinary | United States |
| Aug 23, 2024 | IDS LTD | Devices | Korea (the Republic of) |
| Aug 23, 2024 | Ivan Carreras, M.D. | Drugs | United States |
| Aug 23, 2024 | Shirish M. Gadgeel, MD | Drugs | United States |
| Aug 23, 2024 | Wichy Plantation Company (Pvt) Ltd | Food/Cosmetics | Sri Lanka |
| Aug 22, 2024 | Integra LifeSciences Corp. (NeuroSciences) | Devices | United States |
| Aug 22, 2024 | Sweet's Elderberry, LLC | Drugs | United States |
| Aug 21, 2024 | Chemspec Chemicals Private Limited | Drugs | India |
| Aug 21, 2024 | Mericon Industries Inc. | Food/Cosmetics | United States |
| Aug 20, 2024 | Dream Wholesale Inc | Food/Cosmetics | United States |
| Aug 20, 2024 | Irvington Seafood, Inc. | Food/Cosmetics | United States |
| Aug 19, 2024 | GRACE SUPPLY INC. | Food/Cosmetics | United States |
| Aug 16, 2024 | Chara Biologics, Inc. | Biologics | United States |
| Aug 16, 2024 | Tyche Industries Ltd. | Drugs | India |
| Aug 15, 2024 | Mother Earth Minerals, Inc. | Food/Cosmetics | United States |
| Aug 15, 2024 | Plaxtron Industrial (M) SDN. BHD. | Devices | Malaysia |
| Aug 15, 2024 | Regent Electron (Suzhou) Co., Ltd. | Devices | China |
| Aug 14, 2024 | American Contract Systems Inc | Devices | United States |
| Aug 14, 2024 | Paso Real Produce LLC | Food/Cosmetics | United States |
| Aug 14, 2024 | Pure Tropic | Food/Cosmetics | India |
| Aug 13, 2024 | Riclan S.A. | Food/Cosmetics | Brazil |
| Aug 12, 2024 | Radhaswamy Inc. | Food/Cosmetics | United States |
| Aug 9, 2024 | KYAW KHIN, INC | Food/Cosmetics | United States |
| Aug 8, 2024 | Blaze USA, LLC | Tobacco | United States |
| Aug 8, 2024 | GALEMED CORP. | Devices | Taiwan |
| Aug 8, 2024 | Randox Laboratories Limited | Devices | United Kingdom |
| Aug 7, 2024 | Raphe Generics Corp | Drugs | United States |
| Aug 5, 2024 | Lucky K.T. Co., Inc. | Food/Cosmetics | United States |
| Aug 2, 2024 | Global Calcium Pvt. Limited | Drugs | India |
| Aug 2, 2024 | JIANGSU KONSUNG BIO-MEDICAL SCIENCE AND TECHNOLOGY CO LTD | Devices | China |
| Aug 2, 2024 | Mixlab TX LLC | Veterinary | United States |
| Aug 2, 2024 | ProRx LLC | Drugs | United States |
| Aug 2, 2024 | Troya Del Campo USA LLC | Food/Cosmetics | United States |
| Aug 1, 2024 | Advanced Pharmaceutical Technology, Inc. | Drugs | United States |
| Aug 1, 2024 | Baxter Healthcare Corporation | Drugs | United States |
| Aug 1, 2024 | Furst-McNess Company | Veterinary | United States |
| Aug 1, 2024 | Madvapes Poplar Tent | Tobacco | United States |
| Aug 1, 2024 | Strukmyer LLC | Drugs | United States |
| Aug 1, 2024 | SUREPULSE MEDICAL LTD | Devices | United Kingdom |
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) | FSVP assurances | 42 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 27 |
| 21 CFR 117.35(c) | Pest control | 27 |
| 21 CFR 117.10 | Personnel | 23 |
| 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls | 23 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 20 |
| 21 CFR 117.135(a)(1) | Sanitation preventive controls - Implement | 18 |
| 21 CFR 117.40 | Equipment and utensils - Design and maintenance | 18 |
| 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard | 17 |
| 21 CFR 111.70(b) | Specifications - components | 15 |
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 |
|---|---|---|---|
| Aug 30, 2024 | Fresenius Kabi USA, LLC | Devices | The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy… |
| Aug 30, 2024 | Mercury Enterprises, Inc. Dba Mercury Medical | Devices | Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step. |
| Aug 27, 2024 | The Posh Bakery, Inc. | Food | Undeclared whey (milk), wheat flour, & bran (wheat); no nutrition fact panel & no contains statement |
| Aug 22, 2024 | Kinova Inc | Devices | Potential installation issue that could result in a fire hazard in the event of an interaction between a damaged Jaco arm and a wheelchair… |
| Aug 22, 2024 | Sri Lakshmi Narasimhar Overseas | Food | Undeclared sesame and milk |
| Aug 22, 2024 | SUNCO & FRENCHIE LLC. | Food | Undeclared sulfites |
| Aug 21, 2024 | Percussionaire Corporation | Devices | Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV… |
| Aug 21, 2024 | Percussionaire Corporation | Devices | Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV… |
| Aug 21, 2024 | Unilever North America Supply Chain Company, LLC | Food | Undeclared milk |
| Aug 20, 2024 | Baxter Healthcare Corporation | Devices | Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets… |
| Aug 20, 2024 | Baxter Healthcare Corporation | Devices | Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets… |
| Aug 20, 2024 | Baxter Healthcare Corporation | Devices | Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets… |
| Aug 20, 2024 | Baxter Healthcare Corporation | Devices | Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets… |
| Aug 20, 2024 | Milo's Poultry Farms, LLC | Food | Eggs have the potential to be contaminated with Salmonella. |
| Aug 16, 2024 | Nuts.Com | Food | Possible Salmonella contamination |
| Aug 9, 2024 | Prime Food Processing Corp. | Food | Products may contain undeclared sesame |
| Aug 9, 2024 | Prime Food Processing Corp. | Food | Products may contain undeclared sesame |
| Aug 8, 2024 | Datascope Corp. | Devices | Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic… |
| Aug 8, 2024 | Datascope Corp. | Devices | Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic… |
| Aug 8, 2024 | Datascope Corp. | Devices | Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic… |
| Aug 8, 2024 | Datascope Corp. | Devices | Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic… |
| Aug 7, 2024 | B Braun Medical Inc | Devices | Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of… |
| Aug 7, 2024 | Meijer Inc | Food | undeclared milk |
| Aug 2, 2024 | PARADISE DISTRIBUTORS, LLC | Food | Undeclared milk. |
| Aug 2, 2024 | PARADISE DISTRIBUTORS, LLC | Food | Undeclared milk. |
| Aug 2, 2024 | PARADISE DISTRIBUTORS, LLC | Food | Undeclared milk. |
| Aug 2, 2024 | PARADISE DISTRIBUTORS, LLC | Food | Undeclared milk. |
| Aug 2, 2024 | PARADISE DISTRIBUTORS, LLC | Food | Undeclared milk. |
| Aug 1, 2024 | Baxter Healthcare Corporation | Drugs | Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. |
| Aug 1, 2024 | Fresenius Kabi USA, LLC | Devices | A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e… |
| Aug 1, 2024 | North Fish USA, Inc. | Food | Clostridium botulinum (uneviscerated fish) |
| Aug 1, 2024 | Thal Golden Spices Inc. | Food | Potential Salmonella contamination. |
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