FDA Warning Letters, 483s and Recalls: September 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 |
|---|---|---|---|
| Sep 30, 2024 | Bacalao Giraldo, S.L.U. | Center for Food Safety and Applied Nutrition | Seafood HACCP/CGMP for Foods/Adulterated |
| Sep 30, 2024 | Dalai Biotech Company Ltd | Human Foods Program | Low Acid Canned Food Regulation/Adulterated |
| Sep 30, 2024 | Knickerbocker 365 Inc. | Office of Human & Animal Food Operations East 6 | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions |
| Sep 30, 2024 | Mexicanrxpharm.Com | Center for Drug Evaluation and Research (CDER) | Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet |
| Sep 30, 2024 | Miyajima Shoyu Co., Ltd. | Center for Food Safety and Applied Nutrition | Acidified Foods/Emergency Permit Control/Adulterated |
| Sep 27, 2024 | Louisiana State University Health Science Center IRB | Center for Drug Evaluation and Research (CDER) | Institutional Review Board (IRB) |
| Sep 26, 2024 | Big Vegetarian Supply, Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Sep 26, 2024 | Makra Kozmetika D.O.O. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 26, 2024 | Supercore Products Group, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| Sep 25, 2024 | Bernardo Farms, LLC | Center for Food Safety and Applied Nutrition | Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption/Food/Prepared, Packed or… |
| Sep 25, 2024 | Outin Futures Corp. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
| Sep 24, 2024 | Ice Cream House LLC | Division of Human and Animal Food Operations East I | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes |
| Sep 24, 2024 | MMC Healthcare Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 24, 2024 | Ya Ya Foods USA, LLC | Division of Human and Animal Food Operations West IV | Low Acid Canned Food Regulation/Adulterated |
| Sep 20, 2024 | Azurity Pharmaceuticals, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
| Sep 17, 2024 | Little Moon Essentials, LLC | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 13, 2024 | Far East Summit LLC | Division of Human and Animal Food Operations West VI | Unapproved New Drugs/Misbranded |
| Sep 12, 2024 | Nomida.Biz | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Sep 12, 2024 | Pacific Exchange Distributors LLC | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Sep 11, 2024 | Alfred Louie, Inc. | Division of Human and Animal Food Operations West V | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Sep 11, 2024 | Healthwest Minerals, Inc. Dba Mt. Capra Products | Division of Human and Animal Food Operations West VI | Interstate Commerce/Food/Adulterated |
| Sep 11, 2024 | JJH Trading Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Sep 11, 2024 | Quality CDMO, Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs |
| Sep 10, 2024 | Aromas Para El Alma S.A. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug/Misbranded |
| Sep 10, 2024 | Micro-X Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Sep 10, 2024 | Mid-Link Testing Company, Ltd | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Sep 10, 2024 | Sanitation & Environmental Technology Institute Dba SDWH | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Sep 9, 2024 | EnviroServe Chemicals & Cleaners Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug/Misbranded |
| Sep 6, 2024 | Clean Solutions LLC | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 6, 2024 | Diamond Chemical Co., Inc. | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 4, 2024 | Troya Del Campo USA LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Sep 3, 2024 | Avaria Health & Beauty Corp. | 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 |
|---|---|---|---|
| Sep 30, 2024 | Pine Pharmaceuticals, LLC | Drugs | United States |
| Sep 27, 2024 | Anfele, S.A. | Food/Cosmetics | Spain |
| Sep 27, 2024 | MOM Enterprises, LLC | Food/Cosmetics | United States |
| Sep 27, 2024 | Phoenix Innovative Healthcare Manufacturers Private Limited | Drugs | India |
| Sep 27, 2024 | RC Outsourcing, LLC | Drugs | United States |
| Sep 27, 2024 | Taixing SynTheAll Pharmaceutical Co., Ltd | Veterinary | China |
| Sep 27, 2024 | Yangzhou Sion Commodity Co., Ltd. | Drugs | China |
| Sep 26, 2024 | Assut Europe S.P.A. | Devices | Italy |
| Sep 26, 2024 | ONY Biotech, Inc. | Drugs | United States |
| Sep 25, 2024 | Mentha & Allied Products Private Ltd. | Drugs | India |
| Sep 25, 2024 | Nephron SC, LLC | Drugs | United States |
| Sep 25, 2024 | Reedhill Ventures LLC | Tobacco | United States |
| Sep 24, 2024 | Hologic, Inc | Devices | United States |
| Sep 23, 2024 | AnazaoHealth Corporation | Drugs | United States |
| Sep 23, 2024 | Marshalls Traditional Healthcare CC | Drugs | South Africa |
| Sep 21, 2024 | Aspen Biopharma Labs Pvt., Ltd. | Drugs | India |
| Sep 20, 2024 | Chem-Tech, Ltd. | Drugs | United States |
| Sep 20, 2024 | China Pharmaceutical University | Drugs | China |
| Sep 20, 2024 | International Laboratories Corp., Limited | Drugs | Thailand |
| Sep 20, 2024 | Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim Sirketi | Drugs | Turkey |
| Sep 20, 2024 | Water-Jel Technologies, LLC | Drugs | United States |
| Sep 19, 2024 | Dentonics, Inc | Devices | United States |
| Sep 18, 2024 | Staska Pharmaceuticals, Inc. | Drugs | United States |
| Sep 17, 2024 | Aspen SA Sterile Operations (Pty) Ltd. | Drugs | South Africa |
| Sep 17, 2024 | EnviroServe Chemicals Inc. | Drugs | United States |
| Sep 17, 2024 | Livestock Nutrition Center, LLC | Veterinary | United States |
| Sep 17, 2024 | Vanguard Soap Llc | Drugs | United States |
| Sep 17, 2024 | Zalmhuys Processing | Food/Cosmetics | Netherlands |
| Sep 13, 2024 | ABR Laboratory LLC | Drugs | United States |
| Sep 13, 2024 | Luster Products Inc | Drugs | United States |
| Sep 13, 2024 | Midlab Incorporated | Drugs | United States |
| Sep 13, 2024 | Spectra Therapy, LLC. | Devices | United States |
| Sep 12, 2024 | Laboratoires Anios | Drugs | France |
| Sep 12, 2024 | Rite-Kem Incorporated | Drugs | United States |
| Sep 12, 2024 | Shree Jaya Laboratories Private Limited | Drugs | India |
| Sep 10, 2024 | Milo's Poultry Farms, LLC | Food/Cosmetics | United States |
| Sep 10, 2024 | St. Louis Calco, LLC | Food/Cosmetics | United States |
| Sep 6, 2024 | Annovex Pharma, Inc. | Drugs | United States |
| Sep 6, 2024 | MACSEN DRUGS | Drugs | India |
| Sep 6, 2024 | Rechon Life Science AB | Drugs | Sweden |
| Sep 6, 2024 | Wuhu Nuowei Chemistry Co., Ltd | Drugs | China |
| Sep 5, 2024 | Living Tree Community Foods | Food/Cosmetics | United States |
| Sep 5, 2024 | Shian Jia Meei Enterprise Co., Ltd. | Devices | Taiwan |
| Sep 4, 2024 | Daddy's Vapor Distro, Inc. | Tobacco | United States |
| Sep 3, 2024 | Generitech Corporation | Drugs | United States |
| Sep 3, 2024 | ZULAND DISTRIBUTOR CORP | 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) | FSVP assurances | 32 |
| 21 CFR 117.135(a)(1) | Sanitation preventive controls - Implement | 22 |
| 21 CFR 117.35(c) | Pest control | 20 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 19 |
| 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls | 18 |
| 21 CFR 211.22(d) | Procedures not in writing, fully followed | 17 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 17 |
| 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard | 16 |
| 21 CFR 211.192 | Investigations of discrepancies, failures | 15 |
| 21 CFR 117.10 | Personnel | 13 |
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 |
|---|---|---|---|
| Sep 30, 2024 | Staska Pharmaceuticals, Inc. | Drugs | Presence of Particulate Matter: Presence of glass particulates. |
| Sep 25, 2024 | Cardinal Health 200, LLC | Devices | Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated… |
| Sep 25, 2024 | Elekta Instrument AB | Devices | Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material… |
| Sep 20, 2024 | Maquet Cardiovascular, LLC | Devices | There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use. |
| Sep 19, 2024 | Gilead Sciences, Inc. | Drugs | Presence of Particulate Matter: Presence of glass particle. |
| Sep 19, 2024 | HP Hood LLC | Food | Milk may contain undeclared almond from almond milk |
| Sep 18, 2024 | 123Herbals | Drugs | Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine. |
| Sep 17, 2024 | Bionpharma Inc. | Drugs | Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria. |
| Sep 16, 2024 | Percussionaire Corporation | Devices | As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy was being given with… |
| Sep 13, 2024 | KTM Services, Inc. | Food | Undeclared allergens; milk |
| Sep 13, 2024 | KTM Services, Inc. | Food | Undeclared allergens; milk |
| Sep 13, 2024 | Nuts.Com | Food | Undeclared Allergen, milk - a mix-up between the product description and the ingredient list. Milk Chocolate was listed in the product… |
| Sep 13, 2024 | Perfection Bakeries LLC | Food | Undeclared sesame |
| Sep 13, 2024 | Perfection Bakeries LLC | Food | Undeclared sesame |
| Sep 13, 2024 | Perfection Bakeries LLC | Food | Undeclared sesame |
| Sep 13, 2024 | Perfection Bakeries LLC | Food | Undeclared sesame |
| Sep 13, 2024 | Perfection Bakeries LLC | Food | Undeclared sesame |
| Sep 13, 2024 | Perfection Bakeries LLC | Food | Undeclared sesame |
| Sep 13, 2024 | Perfection Bakeries LLC | Food | Undeclared sesame |
| Sep 13, 2024 | Zyno Medical LLC | Devices | There is a defect in the air-in-line software algorithm. |
| Sep 12, 2024 | Baxter Healthcare Corporation | Devices | The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or… |
| Sep 11, 2024 | Lemonland Food Corp | Food | Soy Bean Paste is declared but Wheat, Fish (Large-eyed Herring, Anchovy), and Crustacean (Shrimp) are not declared. |
| Sep 11, 2024 | Lemonland Food Corp | Food | Soybean Sauce is declared but Wheat and Fish (Anchovy) are not declared. |
| Sep 11, 2024 | Lemonland Food Corp | Food | Undeclared Crustacean (shrimp). |
| Sep 11, 2024 | Lemonland Food Corp | Food | Mayonnaise is declared but Soybean Oil and Egg are not declared. |
| Sep 11, 2024 | Lemonland Food Corp | Food | Undeclared Fish (Anchovy). |
| Sep 11, 2024 | Lemonland Food Corp | Food | Undeclared Fish (Anchovy). |
| Sep 9, 2024 | Innovation Bakers, LLC | Food | Undeclared allergens; walnuts |
| Sep 6, 2024 | Gorilla Mind LLC | Food | Product was recalled due to the potential for contamination with Salmonella |
| Sep 5, 2024 | Eagle Produce LLC, Dba Martori Farms | Food | Possible contamination with Salmonella spp. |
| Sep 3, 2024 | DATEX--OHMEDA, INC. | Devices | GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors… |
| Sep 3, 2024 | DATEX--OHMEDA, INC. | Devices | GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors… |
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