FDA Warning Letters, 483s and Recalls: October 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 |
|---|---|---|---|
| Oct 30, 2024 | Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Oct 29, 2024 | Armstrong County Memorial Hospital | Center for Drug Evaluation and Research (CDER) | Institutional Review Board (IRB) |
| Oct 29, 2024 | Tova Industries, LLC | Human Foods Program | Acidified Foods/Emergency Permit Control/Adulterated |
| Oct 28, 2024 | Rontis Hellas S.A. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Oct 25, 2024 | Calavo Growers, Inc. | Human Foods Program | Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption/Food/Prepared, Packed or… |
| Oct 25, 2024 | Rise N’ Shine Farm, Inc. | Human Foods Program | PHS Act/Shell Egg Regulation/Adulterated |
| Oct 24, 2024 | Fancy Drops Beauty LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Oct 23, 2024 | MedOffice Saglik Endustri Anonim Sirketi | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Oct 22, 2024 | Ardent Animal Health, LLC | Center for Veterinary Medicine | Unapproved New Animal Drug Products |
| Oct 22, 2024 | Chongqing Tianrun Food Development Co., Ltd | Human Foods Program | Low Acid Canned Food Regulation/Adulterated |
| Oct 21, 2024 | Choice All Natural, Inc. Dba Om Botanical | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Oct 18, 2024 | Rolence Ent. Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Oct 17, 2024 | Diora Kimya Sanayi Ve Ticaret Limited Sirketi | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded/Failure to Register |
| Oct 17, 2024 | Grupo VPAS C.A. | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated |
| Oct 17, 2024 | Maruhachi Muramatsu Inc., Danchi Factory | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated |
| Oct 11, 2024 | Adept Medical Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Oct 11, 2024 | Blackfly Investments, LLC Dba Molecular® Testing Labs | Center for Biologics Evaluation and Research (CBER) | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Oct 10, 2024 | Analytical Food Laboratories, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Oct 10, 2024 | Future Best Trading Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Oct 10, 2024 | Namita A. Goyal, M.D. | Center for Biologics Evaluation and Research (CBER) | Clinical Investigator |
| Oct 10, 2024 | Soliteint Kozmetikai KFT | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Oct 8, 2024 | Hemarus LLC | Center for Biologics Evaluation and Research (CBER) | CGMP/Blood & Blood Components/Adulterated |
| Oct 7, 2024 | Hangzhou Glamcos Biotech Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
| Oct 2, 2024 | Omni Lens Pvt. Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded/Failure to Register |
| Oct 1, 2024 | Amnio Technology, LLC | Center for Biologics Evaluation and Research (CBER) | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Oct 1, 2024 | Paso Real Produce LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Oct 1, 2024 | Pinnacle Transplant Technologies, LLC | Center for Biologics Evaluation and Research (CBER) | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
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 |
|---|---|---|---|
| Oct 31, 2024 | Westwood Laboratories, LLC. | Veterinary | United States |
| Oct 30, 2024 | Westway Feed Products | Veterinary | United States |
| Oct 29, 2024 | Gastraval S.L. | Food/Cosmetics | Spain |
| Oct 29, 2024 | Mol Belting Systems | Drugs | United States |
| Oct 29, 2024 | Univar Solutions USA LLC | Drugs | United States |
| Oct 25, 2024 | Cosco International, Inc. | Drugs | United States |
| Oct 25, 2024 | OSRX Inc. | Drugs | United States |
| Oct 24, 2024 | Exer Labs, Inc. | Devices | United States |
| Oct 24, 2024 | Valentine Enterprises, Inc. | Food/Cosmetics | United States |
| Oct 24, 2024 | Zep Inc | Drugs | United States |
| Oct 23, 2024 | La Milagrosa 1 LLC | Food/Cosmetics | United States |
| Oct 22, 2024 | Boothwyn Pharmacy LLC | Veterinary | United States |
| Oct 22, 2024 | Fairy Tales Hair Care Inc. | Drugs | United States |
| Oct 21, 2024 | Jack & The Green Sprouts, Inc. | Food/Cosmetics | United States |
| Oct 18, 2024 | Devalingam Mahalingam, M.D., Ph.D. | Drugs | United States |
| Oct 18, 2024 | Ng Zheng Inc | Food/Cosmetics | United States |
| Oct 18, 2024 | NWL Netherlands Services B.V. | Drugs | Netherlands |
| Oct 17, 2024 | Bioasia Worldwide Sdn Bhd | Drugs | Malaysia |
| Oct 16, 2024 | Fresenius Medical Care Renal Therapies Group, LLC | Devices | United States |
| Oct 15, 2024 | Health And Natural Beauty USA Corp | Drugs | United States |
| Oct 15, 2024 | Pamela K. Den Besten, DDS | Drugs | United States |
| Oct 14, 2024 | NOSAFOOD JOINT STOCK COMPANY - BEN LUC BRANCH | Food/Cosmetics | Vietnam |
| Oct 12, 2024 | Cosmaceutical Research Lab Inc. | Drugs | Canada |
| Oct 11, 2024 | DON TORO FOODS, LLC | Food/Cosmetics | United States |
| Oct 11, 2024 | Yiling Pharmaceutical Ltd. | Drugs | China |
| Oct 9, 2024 | AH USA Group Inc | Food/Cosmetics | United States |
| Oct 9, 2024 | Jap Inc. | Food/Cosmetics | United States |
| Oct 8, 2024 | CHAUGIAFOOD TRADING PRODUCTION CO.,LTD | Food/Cosmetics | Vietnam |
| Oct 4, 2024 | Empower Clinic Services, LLC | Drugs | United States |
| Oct 4, 2024 | Lystn, LLC | Veterinary | United States |
| Oct 4, 2024 | United Health Products, Inc. | Devices | United States |
| Oct 3, 2024 | Farmers Coop Elevator Co Inc | Veterinary | 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 | 38 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 23 |
| 21 CFR 117.35(c) | Pest control | 23 |
| 21 CFR 211.22(d) | Procedures not in writing, fully followed | 17 |
| 21 CFR 117.10 | Personnel | 15 |
| 21 CFR 211.192 | Written record of investigation incomplete | 15 |
| 21 CFR 312.60 | Informed consent | 15 |
| 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls | 13 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 13 |
| 21 CFR 211.100(a) | Absence of Written 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 |
|---|---|---|---|
| Oct 25, 2024 | Grand Central Bakery FRE Co Inc | Food | Undeclared egg |
| Oct 25, 2024 | Grand Central Bakery FRE Co Inc | Food | Undeclared egg |
| Oct 25, 2024 | Grand Central Bakery FRE Co Inc | Food | Undeclared egg |
| Oct 25, 2024 | Grand Central Bakery FRE Co Inc | Food | Undeclared egg |
| Oct 22, 2024 | Acme Smoked Fish Corp. | Food | The firm was notified after laboratory analysis that the product test positive for Listeria monocytogenes. |
| Oct 22, 2024 | FreshPoint Denver, Incorporated | Food | Potentially contaminated with E. coli O157:H7. |
| Oct 22, 2024 | FreshPoint Denver, Incorporated | Food | Potentially contaminated with E. coli O157:H7. |
| Oct 22, 2024 | ICU Medical, Inc. | Devices | ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM… |
| Oct 22, 2024 | Taylor Farms Colorado, Inc. | Food | Potential contamination of E. coli O157:H7 |
| Oct 22, 2024 | Taylor Farms Colorado, Inc. | Food | Potential contamination of E. coli O157:H7 |
| Oct 22, 2024 | Taylor Farms Colorado, Inc. | Food | Potential contamination of E. coli O157:H7 |
| Oct 22, 2024 | Taylor Farms Colorado, Inc. | Food | Potential contamination of E. coli O157:H7 |
| Oct 21, 2024 | Baxter Healthcare Corporation | Devices | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL)… |
| Oct 21, 2024 | Baxter Healthcare Corporation | Devices | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL)… |
| Oct 21, 2024 | Baxter Healthcare Corporation | Devices | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL)… |
| Oct 21, 2024 | Baxter Healthcare Corporation | Devices | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL)… |
| Oct 21, 2024 | Baxter Healthcare Corporation | Devices | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL)… |
| Oct 21, 2024 | Baxter Healthcare Corporation | Devices | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL)… |
| Oct 21, 2024 | Baxter Healthcare Corporation | Devices | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL)… |
| Oct 21, 2024 | Baxter Healthcare Corporation | Devices | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL)… |
| Oct 21, 2024 | Baxter Healthcare Corporation | Devices | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL)… |
| Oct 21, 2024 | Baxter Healthcare Corporation | Devices | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL)… |
| Oct 21, 2024 | One Roof LLC | Food | Undeclared tree nuts (almonds) |
| Oct 18, 2024 | Fresh Express Incorpated | Food | Potential Listeria Monocytogenes Contamination. The pre-packaged condiment trays contains chicken linked to the Bruce Pac recall. |
| Oct 18, 2024 | Fresh Express Incorpated | Food | Potential Listeria Monocytogenes Contamination. The pre-packaged condiment trays contains chicken linked to the Bruce Pac recall. |
| Oct 16, 2024 | Baxter Healthcare Corporation | Devices | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL)… |
| Oct 15, 2024 | Draeger Medical, Inc. | Devices | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical… |
| Oct 15, 2024 | Draeger Medical, Inc. | Devices | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical… |
| Oct 15, 2024 | Draeger Medical, Inc. | Devices | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical… |
| Oct 15, 2024 | Draeger Medical, Inc. | Devices | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical… |
| Oct 11, 2024 | CON YEAGER SPICE CO. | Food | Undeclared Allergen - Wheat and Soy |
| Oct 11, 2024 | Dakota Tom's, Inc | Food | Potential Listeria monocytogenes contamination |
| Oct 11, 2024 | Dakota Tom's, Inc | Food | Potential Listeria monocytogenes contamination |
| Oct 11, 2024 | Dakota Tom's, Inc | Food | Potential Listeria monocytogenes contamination |
| Oct 11, 2024 | HH FRESH TRADING CORP | Food | Potential contamination of Listeria monocytogenes |
| Oct 10, 2024 | Albertsons Companies LLC | Food | Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes |
| Oct 10, 2024 | Boston Scientific Corporation | Devices | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to… |
| Oct 10, 2024 | Boston Scientific Corporation | Devices | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to… |
| Oct 10, 2024 | Boston Scientific Corporation | Devices | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to… |
| Oct 10, 2024 | Boston Scientific Corporation | Devices | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to… |
| Oct 10, 2024 | Boston Scientific Corporation | Devices | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to… |
| Oct 10, 2024 | Boston Scientific Corporation | Devices | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to… |
| Oct 10, 2024 | Boston Scientific Corporation | Devices | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to… |
| Oct 10, 2024 | Enoki King Mushroom Farm Inc. | Food | The product was found to have Listeria monocytogenes |
| Oct 10, 2024 | Hologic, Inc | Devices | Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration… |
| Oct 10, 2024 | Reser's Fine Foods, Inc. | Food | Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes |
| Oct 10, 2024 | Reser's Fine Foods, Inc. | Food | Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes |
| Oct 9, 2024 | Joseph Seviroli, LLC | Food | Contains chicken contaiminated with Listeria monocytogenes |
| Oct 9, 2024 | Wismettac Asian Foods, Inc. | Food | Undeclared allergens; sesame |
| Oct 7, 2024 | Philips Respironics, Inc. | Devices | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow… |
| Oct 7, 2024 | Philips Respironics, Inc. | Devices | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow… |
| Oct 7, 2024 | Philips Respironics, Inc. | Devices | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow… |
| Oct 7, 2024 | Philips Respironics, Inc. | Devices | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow… |
| Oct 7, 2024 | Philips Respironics, Inc. | Devices | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow… |
| Oct 7, 2024 | Philips Respironics, Inc. | Devices | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow… |
| Oct 7, 2024 | Philips Respironics, Inc. | Devices | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow… |
| Oct 4, 2024 | FHC, Inc. | Devices | A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube… |
| Oct 4, 2024 | Tipical Latin Food, Corp. Dba La Pradera | Food | Undeclared allergen:Wheat |
| Oct 3, 2024 | Choi's Kimchi LLC | Food | Salmonella. |
| Oct 1, 2024 | Jack & The Green Sprouts, Inc. | Food | Sprouts may be contaminated with Listeria monocytogenes. |
| Oct 1, 2024 | Jack & The Green Sprouts, Inc. | Food | Sprouts may be contaminated with Listeria monocytogenes. |
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