FDA Warning Letters, 483s and Recalls: November 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 |
|---|---|---|---|
| Nov 26, 2024 | Duong Ha Processing Trading Seafood Company Limited | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated |
| Nov 22, 2024 | Argon Medical Productions & Vertrieb Gesellschaft MBH & CO | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Nov 22, 2024 | Becton, Dickinson, And Company/CareFusion 303, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Nov 22, 2024 | Mid America Pet Food LLC | Center for Veterinary Medicine | CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Nov 21, 2024 | Catwalk Cosmetic Laboratories Pty Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Nov 21, 2024 | Dr. Brite, LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Nov 21, 2024 | LCC Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug/Misbranded |
| Nov 20, 2024 | Eurosirel S.P.A | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Nov 18, 2024 | Breadbox Co. | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Nov 18, 2024 | Hangzhou Huiji Biotechnology Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Nov 18, 2024 | Stew Leonard’S Holdings LLC | Human Foods Program | Food Labeling/Misbranded |
| Nov 15, 2024 | Centura Pharmaceuticals Inc | Center for Drug Evaluation and Research (CDER) | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/OTC |
| Nov 14, 2024 | Salt City Baking Company, LLC | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Nov 13, 2024 | Guangzhou Four E’S Scientific Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Nov 13, 2024 | Western Innovations, Inc. | Human Foods Program | CGMP/Dietary Supplement/Adulterated |
| Nov 12, 2024 | Energetic Essences, LLC Dba Pet Essences | Center for Veterinary Medicine | New Animal Drug/Adulterated |
| Nov 12, 2024 | Evolution Pets LLC | Center for Veterinary Medicine | New Animal Drug/Adulterated |
| Nov 12, 2024 | HDFrenchies LLC Dba Bully Baum | Center for Veterinary Medicine | New Animal Drug/Adulterated |
| Nov 12, 2024 | Intermarket Industries Inc. Dba Doc Ackerman Pet Products | Center for Veterinary Medicine | New Animal Drug/Adulterated |
| Nov 12, 2024 | Nutrition Strength Ltd. | Center for Veterinary Medicine | New Animal Drug/Adulterated |
| Nov 12, 2024 | Veterinary Select Formula Dba Allergic Pet | Center for Veterinary Medicine | New Animal Drug/Adulterated |
| Nov 12, 2024 | Zhejiang Uniquality Nursing Products Technology Co., Ltd. Dba ZheJiang YouQuan Care Products Technology Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Nov 7, 2024 | Originitalia SRL | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Nov 7, 2024 | Zhejiang Qimei Cosmetics Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Nov 6, 2024 | Eden F&C Co., Ltd | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Nov 6, 2024 | Richard W. Foltin, Ph.D. | Center for Drug Evaluation and Research (CDER) | Clinical Investigator (Sponsor) |
| Nov 6, 2024 | Unexo Lifesciences, Private Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Nov 5, 2024 | Colgate-Palmolive/Tom's Of Maine, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Nov 5, 2024 | Mariscos Procesados - CAMPRESA - S.A. | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated |
| Nov 5, 2024 | Multaler Et Cie SAS | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
| Nov 5, 2024 | Purcell International | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Nov 4, 2024 | Caribbean Produce Exchange, LLC | Division of Southeast Imports | Foreign Supplier Verification Program (FSVP) |
| Nov 4, 2024 | WANABANA USA LLC | Division of Southeast Imports | Foreign Supplier Verification Program (FSVP) |
| Nov 1, 2024 | Frontier Biologics, LLC | Center for Biologics Evaluation and Research | Unapproved New Drug/Unlicensed Biological Product Violations |
| Nov 1, 2024 | Owens & Minor, Inc. Dba American Contract Systems, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Nov 1, 2024 | Yeshua Bendito, C.A. | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
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 |
|---|---|---|---|
| Nov 27, 2024 | Augustine Temperature Management, LLC | Devices | United States |
| Nov 27, 2024 | Product Society LLC | Drugs | United States |
| Nov 26, 2024 | Marin Baking LLC | Food/Cosmetics | United States |
| Nov 26, 2024 | Noah Medical Corporation | Devices | United States |
| Nov 25, 2024 | By George Food Specialties Inc | Food/Cosmetics | United States |
| Nov 25, 2024 | Gracie's Kitchens Inc. | Food/Cosmetics | United States |
| Nov 25, 2024 | PREMIUM FRESH GROWERS LLC | Food/Cosmetics | United States |
| Nov 22, 2024 | AACE Pharmaceuticals, Inc. | Drugs | United States |
| Nov 22, 2024 | Edge Biologicals Inc | Devices | United States |
| Nov 22, 2024 | Hajung Salted Seafood | Food/Cosmetics | Korea (the Republic of) |
| Nov 22, 2024 | Prisha Cosmetics Inc | Drugs | United States |
| Nov 22, 2024 | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | Devices | China |
| Nov 22, 2024 | SmartScience Laboratories, Inc. | Drugs | United States |
| Nov 21, 2024 | Putian Huifeng Food Industry Co., Ltd. | Food/Cosmetics | China |
| Nov 21, 2024 | Taizhou Jingshang Cosmetics Technology Co., Ltd. | Drugs | China |
| Nov 21, 2024 | Tens Plus Industrial Co. | Devices | Hong Kong SAR |
| Nov 20, 2024 | Center For Immunology Science, LLC | Drugs | United States |
| Nov 20, 2024 | Mister-E-Liquid LLC | Tobacco | United States |
| Nov 20, 2024 | Zhengzhou Jialong Food Co., Ltd. | Food/Cosmetics | China |
| Nov 19, 2024 | Excel Vision | Drugs | France |
| Nov 19, 2024 | Holi Hemp LLC | Drugs | United States |
| Nov 19, 2024 | Janssen Vaccines Corp. | Drugs | Korea (the Republic of) |
| Nov 15, 2024 | DO & CO Detroit, Inc. | Food/Cosmetics | United States |
| Nov 15, 2024 | Exela Pharma Sciences LLC | Drugs | United States |
| Nov 15, 2024 | Gongora USA Corp. | Food/Cosmetics | United States |
| Nov 15, 2024 | HLSCIENCE CO.,LTD | Drugs | Korea (the Republic of) |
| Nov 15, 2024 | Iacofano's Group LLC | Food/Cosmetics | United States |
| Nov 15, 2024 | Wuxi Medical Lnstrument Factory Co., Ltd. | Drugs | China |
| Nov 14, 2024 | Everything Sprouts, LLC | Food/Cosmetics | United States |
| Nov 13, 2024 | HICHIFUKU JYOZO CO.,LTD. | Food/Cosmetics | Japan |
| Nov 13, 2024 | NYUMBANI HAKUNA MATATA LLC | Food/Cosmetics | United States |
| Nov 12, 2024 | MAPLAO NAMHOM THAI COMPANY LIMITED | Food/Cosmetics | Thailand |
| Nov 8, 2024 | Aopline Health Industry Technology (Guangzhou) Co., Ltd. | Drugs | China |
| Nov 8, 2024 | Carolina Prime Pet, Inc. | Veterinary | United States |
| Nov 8, 2024 | Hanmi Science Co., Ltd. | Food/Cosmetics | Korea (the Republic of) |
| Nov 8, 2024 | Mark Dacey, M.D. | Drugs | United States |
| Nov 8, 2024 | PMS4PMS, LLC | Drugs | United States |
| Nov 7, 2024 | Candymar Produce Inc | Food/Cosmetics | United States |
| Nov 7, 2024 | Dexcom, Inc. | Devices | United States |
| Nov 7, 2024 | DRG Instruments GmbH | Devices | Germany |
| Nov 6, 2024 | Optimal Solution Labs LLC | Drugs | United States |
| Nov 6, 2024 | The Kuwaiti Danish Dairy Company KCSC | Food/Cosmetics | Kuwait |
| Nov 5, 2024 | Sea-Long Medical Systems, LLC | Devices | United States |
| Nov 5, 2024 | SOHM, Inc. | Drugs | United States |
| Nov 4, 2024 | BEO Pharma Inc | Drugs | United States |
| Nov 4, 2024 | Hans Bakery, Inc. | Food/Cosmetics | United States |
| Nov 1, 2024 | Blendpack Inc | Veterinary | United States |
| Nov 1, 2024 | Dyno Manufacturing, Inc. | Drugs | 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 | 47 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 25 |
| 21 CFR 117.135(a)(1) | Sanitation preventive controls - Implement | 24 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 21 |
| 21 CFR 211.22(d) | Procedures not in writing, fully followed | 21 |
| 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard | 18 |
| 21 CFR 117.10 | Personnel | 17 |
| 21 CFR 117.35(c) | Pest control | 17 |
| 21 CFR 211.100(a) | Absence of Written Procedures | 15 |
| 21 CFR 117.37 | Sanitary facilities and controls | 14 |
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 |
|---|---|---|---|
| Nov 30, 2024 | Sysco Corporation | Food | Cucumbers have the potential to be contaminated with Salmonella. |
| Nov 30, 2024 | Sysco Corporation | Food | Cucumbers have the potential to be contaminated with Salmonella. |
| Nov 29, 2024 | BALOIAN FARMS | Food | Cucumbers potentially contaminated with Salmonella. |
| Nov 29, 2024 | E-Z SPUDS INC | Food | Potential for Salmonella |
| Nov 29, 2024 | GBC Food Services, LLC Dba Yummi Sushi | Food | Potential Salmonella |
| Nov 29, 2024 | GBC Food Services, LLC Dba Yummi Sushi | Food | Potential Salmonella |
| Nov 29, 2024 | GBC Food Services, LLC Dba Yummi Sushi | Food | Potential Salmonella |
| Nov 29, 2024 | GBC Food Services, LLC Dba Yummi Sushi | Food | Potential Salmonella |
| Nov 29, 2024 | GBC Food Services, LLC Dba Yummi Sushi | Food | Potential Salmonella |
| Nov 29, 2024 | GBC Food Services, LLC Dba Yummi Sushi | Food | Potential Salmonella |
| Nov 29, 2024 | GBC Food Services, LLC Dba Yummi Sushi | Food | Possible contamination with Salmonella |
| Nov 29, 2024 | GBC Food Services, LLC Dba Yummi Sushi | Food | Possible contamination with Salmonella |
| Nov 29, 2024 | GBC Food Services, LLC Dba Yummi Sushi | Food | Potential Salmonella |
| Nov 29, 2024 | GBC Food Services, LLC Dba Yummi Sushi | Food | Possible contamination with Salmonella |
| Nov 29, 2024 | GBC Food Services, LLC Dba Yummi Sushi | Food | Possible contamination with Salmonella |
| Nov 29, 2024 | GBC Food Services, LLC Dba Yummi Sushi | Food | Possible contamination with Salmonella |
| Nov 29, 2024 | GBC Food Services, LLC Dba Yummi Sushi | Food | Possible contamination with Salmonella |
| Nov 29, 2024 | GBC Food Services, LLC Dba Yummi Sushi | Food | Potential Salmonella |
| Nov 29, 2024 | GBC Food Services, LLC Dba Yummi Sushi | Food | Potential Salmonella |
| Nov 29, 2024 | GBC Food Services, LLC Dba Yummi Sushi | Food | Potential Salmonella |
| Nov 29, 2024 | GBC Food Services, LLC Dba Yummi Sushi | Food | Possible contamination with Salmonella |
| Nov 29, 2024 | GBC Food Services, LLC Dba Yummi Sushi | Food | Potential Salmonella |
| Nov 29, 2024 | GBC Food Services, LLC Dba Yummi Sushi | Food | Potential Salmonella |
| Nov 29, 2024 | GBC Food Services, LLC Dba Yummi Sushi | Food | Potential Salmonella |
| Nov 29, 2024 | Indianapolis Fruit Company, Inc. | Food | potential for salmonella |
| Nov 29, 2024 | JFE FRANCHISING INC | Food | Potential to be contaminated with Salmonella |
| Nov 29, 2024 | JFE FRANCHISING INC | Food | Potential to be contaminated with Salmonella |
| Nov 29, 2024 | JFE FRANCHISING INC | Food | Potential to be contaminated with Salmonella |
| Nov 29, 2024 | JFE FRANCHISING INC | Food | Potential to be contaminated with Salmonella |
| Nov 29, 2024 | JFE FRANCHISING INC | Food | Potential to be contaminated with Salmonella |
| Nov 29, 2024 | JFE FRANCHISING INC | Food | Potential to be contaminated with Salmonella |
| Nov 29, 2024 | Olympia Foods | Food | potential for salmonella |
| Nov 29, 2024 | RGB Soda, LLC. | Food | Potential contamination with Salmonella. |
| Nov 29, 2024 | Terry And Joe Baker Farms, LLC Dba Baker Farms | Food | The firm was notified by the Texas Department of Agriculture that the product test positive for Listeria monocytogenes. |
| Nov 29, 2024 | The Kroger Co | Food | Platters and trays prepared in-store may contain cut cucumbers that were previously recalled due to potential contamination with Salmonella. |
| Nov 29, 2024 | The Kroger Co | Food | Platters and trays prepared in-store may contain cut cucumbers that were previously recalled due to potential contamination with Salmonella. |
| Nov 29, 2024 | The Kroger Co | Food | Platters and trays prepared in-store may contain cut cucumbers that were previously recalled due to potential contamination with Salmonella. |
| Nov 29, 2024 | The Kroger Co | Food | Platters and trays prepared in-store may contain cut cucumbers that were previously recalled due to potential contamination with Salmonella. |
| Nov 28, 2024 | Walmart Inc | Food | Sliced cucumbers have the potential to be contaminated with Salmonella. |
| Nov 27, 2024 | Bazzini LLC | Food | The product is being recalled because of undeclared milk . |
| Nov 27, 2024 | Bazzini LLC | Food | The product is being recalled because of undeclared milk . |
| Nov 27, 2024 | Bazzini LLC | Food | The product is being recalled because of undeclared milk . |
| Nov 27, 2024 | Dairyland Produce, LLC | Food | Cucumbers have the potential to be contaminated with Salmonella. |
| Nov 27, 2024 | Delta Fresh LLC. | Food | Potential Salmonella contamination of fresh cucumbers. Associated with an outbreak. |
| Nov 27, 2024 | HARDIES FRESH FOODS | Food | Cucumbers have the potential to be contaminated with Salmonella |
| Nov 27, 2024 | Trokamed GmbH | Devices | If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone… |
| Nov 27, 2024 | Trokamed GmbH | Devices | If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone… |
| Nov 27, 2024 | Trokamed GmbH | Devices | If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone… |
| Nov 27, 2024 | Trokamed GmbH | Devices | If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone… |
| Nov 26, 2024 | Handsome Brook Farms, LLC | Food | Eggs from a positive Salmonella environment were shipped into distribution to retail facilities. |
| Nov 26, 2024 | SunFed Produce, Inc. | Food | Cucumbers potentially contaminated with Salmonella. |
| Nov 25, 2024 | SE Tampa Inc Dba Tampa Food | Food | Undeclared allergens: Milk, Soy, Crustacea Shellfish, Fish |
| Nov 20, 2024 | Nova Biomedical Corporation | Devices | A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare… |
| Nov 20, 2024 | Nova Biomedical Corporation | Devices | A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare… |
| Nov 20, 2024 | Nova Biomedical Corporation | Devices | A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a… |
| Nov 18, 2024 | 4 Earth Farms Formerly Mcl Fresh Inc | Food | potential contamination with E. coli O121:H19 |
| Nov 18, 2024 | 4 Earth Farms Formerly Mcl Fresh Inc | Food | potential contamination with E. coli O121:H19 |
| Nov 18, 2024 | 4 Earth Farms Formerly Mcl Fresh Inc | Food | potential contamination with E. coli O121:H19 |
| Nov 18, 2024 | 4 Earth Farms Formerly Mcl Fresh Inc | Food | potential contamination with E. coli O121:H19 |
| Nov 18, 2024 | 4 Earth Farms Formerly Mcl Fresh Inc | Food | potential contamination with E. coli O121:H19 |
| Nov 18, 2024 | 4 Earth Farms Formerly Mcl Fresh Inc | Food | potential contamination with E. coli O121:H19 |
| Nov 18, 2024 | 4 Earth Farms Formerly Mcl Fresh Inc | Food | potential contamination with E. coli O121:H19 |
| Nov 18, 2024 | 4 Earth Farms Formerly Mcl Fresh Inc | Food | potential contamination with E. coli O121:H19 |
| Nov 18, 2024 | 4 Earth Farms Formerly Mcl Fresh Inc | Food | potential contamination with E. coli O121:H19 |
| Nov 18, 2024 | Endo USA, Inc. | Drugs | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the… |
| Nov 18, 2024 | Endo USA, Inc. | Drugs | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the… |
| Nov 18, 2024 | Endo USA, Inc. | Drugs | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the… |
| Nov 18, 2024 | Endo USA, Inc. | Drugs | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the… |
| Nov 18, 2024 | Fabalish, | Food | Potential E Coli contamination. |
| Nov 18, 2024 | F&S Fresh Foods, Inc. | Food | Potential contamination with E. coli O121:H19 |
| Nov 18, 2024 | F&S Fresh Foods, Inc. | Food | Potential contamination with E. coli O121:H19 |
| Nov 16, 2024 | Grimmway Enterprises, Inc. Dba Grimmway Farms | Food | Potential contamination with E. coli O121:H19 |
| Nov 16, 2024 | Grimmway Enterprises, Inc. Dba Grimmway Farms | Food | Potential contamination with E. coli O121:H19 |
| Nov 16, 2024 | Grimmway Enterprises, Inc. Dba Grimmway Farms | Food | Potential contamination with E. coli O121:H19 |
| Nov 16, 2024 | Grimmway Enterprises, Inc. Dba Grimmway Farms | Food | Potential contamination with E. coli O121:H19 |
| Nov 16, 2024 | Grimmway Enterprises, Inc. Dba Grimmway Farms | Food | Potential contamination with E. coli O121:H19 |
| Nov 14, 2024 | Braga Fresh Foods LLC | Food | Potential contamination with Listeria monocytogenes. |
| Nov 14, 2024 | Kirwan Surgical Products, LLC | Devices | Potential for the outer stainless-steel tube to break or detach. |
| Nov 14, 2024 | Kirwan Surgical Products, LLC | Devices | Potential for the outer stainless-steel tube to break or detach. |
| Nov 14, 2024 | Kirwan Surgical Products, LLC | Devices | Potential for the outer stainless-steel tube to break or detach. |
| Nov 14, 2024 | Kirwan Surgical Products, LLC | Devices | Potential for the outer stainless-steel tube to break or detach. |
| Nov 14, 2024 | Kirwan Surgical Products, LLC | Devices | Potential for the outer stainless-steel tube to break or detach. |
| Nov 14, 2024 | Kirwan Surgical Products, LLC | Devices | Potential for the outer stainless-steel tube to break or detach. |
| Nov 14, 2024 | Kirwan Surgical Products, LLC | Devices | Potential for the outer stainless-steel tube to break or detach. |
| Nov 12, 2024 | Gilster-Mary Lee Corporation Cake Plant | Food | Undeclared egg |
| Nov 8, 2024 | Wegmans Food Markets, Inc. | Food | Contains undeclared egg |
| Nov 4, 2024 | Boulla LLC | Drugs | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. |
| Nov 4, 2024 | Boulla LLC | Drugs | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. |
| Nov 4, 2024 | Boulla LLC | Drugs | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. |
| Nov 4, 2024 | Boulla LLC | Drugs | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. |
| Nov 1, 2024 | Lithuanian Bakery, Inc. | Food | Products contain undeclared allergens (milk, soy, and wheat) and undeclared sulfites, yellow 5, yellow 6. |
| Nov 1, 2024 | Medtronic Neurosurgery | Devices | Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system… |
| Nov 1, 2024 | Medtronic Neurosurgery | Devices | Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system… |
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.