FDA Warning Letters, 483s and Recalls: September 2023
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 29, 2023 | Kari-Fresh LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Sep 29, 2023 | Spectrum Medical Ltd | "OHT2: Office of Cardiovascular Devices, Office of Product Evaluation and Quality" | CGMP/QSR/Medical Devices/Adulterated |
| Sep 29, 2023 | Www.Alphamedstore.Com | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| Sep 28, 2023 | Fanta Seafoods | Center for Food Safety and Applied Nutrition | Seafood HACCP/CGMP for Foods/Adulterated |
| Sep 28, 2023 | GCHNC LLC Dba Hemp XR/Gate City Hemp Dba Hemp XR/Allaziya Enterprises, LLC Dba Hemp XR | Center for Food Safety and Applied Nutrition (CFSAN) | Premarket Approval/Adulterated |
| Sep 28, 2023 | Infinant Health, Inc Formerly Evolve Biosystems Inc. | Center for Biologics Evaluation and Research (CBER) | Unapproved New Drugs/Misbranded |
| Sep 26, 2023 | Antonio E. Blanco, M.D./Vista Health Research, LLC | Center for Drug Evaluation and Research | CDER | Clinical Investigator |
| Sep 26, 2023 | Apollo Import Export, Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Sep 25, 2023 | Shot Of Joy LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| Sep 22, 2023 | Sonesta Medical AB | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Sep 20, 2023 | Kyawkhin Inc. | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) |
| Sep 20, 2023 | Luis Javier Pena-Hernandez, M.D., FCCP | Center for Drug Evaluation and Research | CDER | Clinical Investigator |
| Sep 20, 2023 | Southern Tier Home Infusion, Inc. Dba Pharmacy Innovations | Division of Pharmaceutical Quality Operations I | Compounding Pharmacy/Adulterated Drug Products |
| Sep 19, 2023 | Abiomed Inc. | Division of Medical Device and Radiological Health Operations East | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded |
| Sep 19, 2023 | Hygienic Labs, LLC | Center for Drug Evaluation and Research | CDER | Refusal to Provide Access to and Copying of Records |
| Sep 19, 2023 | P.T. Sankei Medical Industries | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Sep 18, 2023 | Signature Biologics, LLC | Division of Biological Products Operations II | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Sep 18, 2023 | Zhao Qing Longda Biotechnology Co. Ltd. | Center for Drug Evaluation and Research | CDER | Refusal to Provide Access to and Copying of Records |
| Sep 14, 2023 | Fresenius Kabi AG | Division of Biological Products Operations I | CGMP Deviations |
| Sep 14, 2023 | Maison Blanche LLC | Center for Drug Evaluation and Research | CDER | Refusal to Provide Access to and Copying of Records |
| Sep 13, 2023 | Curexa – East, LLC Dba Curexa | Office of Pharmaceutical Quality | Compounding Pharmacy/Adulterated Drug Products |
| Sep 12, 2023 | Gulf States International, Inc. | Center for Drug Evaluation and Research | CDER | Refusal to Provide Access to and Copying of Records |
| Sep 12, 2023 | Walgreen Company | Center for Drug Evaluation and Research | CDER | Failure to Register and List |
| Sep 11, 2023 | Boiron, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| Sep 11, 2023 | CVS Health | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| Sep 11, 2023 | Desserts By Helen, Inc. | Division of Human and Animal Food Operations East V | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Sep 11, 2023 | DR Vitamins, LLC Dba DR Vitamin Solutions | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| Sep 11, 2023 | Kor-Chem, Inc. | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 11, 2023 | Natural Ophthalmics, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| Sep 11, 2023 | OcluMed LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| Sep 11, 2023 | Similasan AG | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
| Sep 11, 2023 | TRP Company, Inc | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| Sep 11, 2023 | Walgreens Boots Alliance, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| Sep 8, 2023 | Shantaba LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Sep 7, 2023 | Oceanitan, Inc. | Division of Human and Animal Food Operations West V | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions |
| Sep 7, 2023 | Perfection Bakeries Inc., Dba Aunt Millie’S Bakeries | Division of Human and Animal Food Operations East VI | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Sep 5, 2023 | BYD Precision Manufacture Co., Ltd | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Sep 5, 2023 | Gondi S.A. | Center for Food Safety and Applied Nutrition | Low Acid Canned Food Regulation/Adulterated |
| Sep 5, 2023 | PT. Winson Prima Sejahtera | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Sep 5, 2023 | Safecor Health, LLC | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 1, 2023 | InnoMark, Inc. | Division of Human and Animal Food Operations West IV | CGMP/Dietary Supplement/Misbranded |
| Sep 1, 2023 | Kimera Labs, Inc. | Division of Biological Products Operations I | Investigational Device Exemptions (IDE) |
| Sep 1, 2023 | PureChemPros LLC | Division of Pharmaceutical Quality Operations IV | 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 29, 2023 | Clinical Resolution Laboratory Inc. | Drugs | United States |
| Sep 29, 2023 | Generitech Corporation | Drugs | United States |
| Sep 29, 2023 | INCELL Corporation LLC | Biologics | United States |
| Sep 29, 2023 | Santec Chemicals Corp. | Drugs | United States |
| Sep 29, 2023 | St. Louis Calco, LLC | Food/Cosmetics | United States |
| Sep 28, 2023 | Swiss Bionic Solutions GmbH | Devices | Switzerland |
| Sep 27, 2023 | Unlit Vapor Shoppe, LLC | Tobacco | United States |
| Sep 26, 2023 | Exactech, Inc. | Devices | United States |
| Sep 25, 2023 | Berkeley Biologics LLC | Biologics | United States |
| Sep 22, 2023 | Cosmetic Solutions LLC | Drugs | United States |
| Sep 22, 2023 | Precision Equine, LLC | Veterinary | United States |
| Sep 21, 2023 | American Cruise Lines Inc/ American Independence | Food/Cosmetics | United States |
| Sep 21, 2023 | Higley Industries, Inc. | Drugs | United States |
| Sep 21, 2023 | International Trading Pharm Lab Inc | Drugs | United States |
| Sep 21, 2023 | Nurse Assist, LLC | Devices | United States |
| Sep 21, 2023 | Richard E. Colgin, Inc | Drugs | United States |
| Sep 21, 2023 | Seaway Pharma Inc. | Drugs | United States |
| Sep 21, 2023 | Steam Puff Vapor LLC | Tobacco | United States |
| Sep 20, 2023 | ARG Laboratories, Inc. | Drugs | United States |
| Sep 20, 2023 | Cosmetic Specialty Labs, Inc | Drugs | United States |
| Sep 20, 2023 | Dercher Enterprises, Inc. | Drugs | United States |
| Sep 19, 2023 | Augustine Temperature Management, LLC | Devices | United States |
| Sep 19, 2023 | Bell International Laboratories, Inc. | Drugs | United States |
| Sep 19, 2023 | Pine Pharmaceuticals, LLC | Drugs | United States |
| Sep 15, 2023 | Aesthetic Plus Company Limited | Drugs | Thailand |
| Sep 15, 2023 | BioStem Life Sciences | Biologics | United States |
| Sep 15, 2023 | DF Global, Inc. | Food/Cosmetics | United States |
| Sep 15, 2023 | McCallum Manufacturing Limited | Drugs | United Kingdom |
| Sep 15, 2023 | Wedgewood Pharmacy LLC | Veterinary | United States |
| Sep 12, 2023 | Agila Corporation | Veterinary | United States |
| Sep 11, 2023 | ULTRAtab Laboratories, Inc. | Drugs | United States |
| Sep 8, 2023 | Distribuidora Jocorena Inc. | Food/Cosmetics | United States |
| Sep 8, 2023 | Sichuan Deebio Pharmaceutical Co., Ltd. | Drugs | China |
| Sep 8, 2023 | Strive Pharmacy Texas LLC | Drugs | United States |
| Sep 7, 2023 | EHM Produce, LLC. | Food/Cosmetics | United States |
| Sep 7, 2023 | Fresenius Kabi USA, LLC | Devices | United States |
| Sep 7, 2023 | Inno Health Technology, Inc. | Devices | Taiwan |
| Sep 7, 2023 | Timothy F. Burns, MD, PhD | Drugs | United States |
| Sep 6, 2023 | GRACE SUPPLY INC. | Food/Cosmetics | United States |
| Sep 1, 2023 | Heres Distributors, LLC | Food/Cosmetics | United States |
| Sep 1, 2023 | JX Restaurants, Inc. | Food/Cosmetics | United States |
| Sep 1, 2023 | SRI Krishna Pharmaceuticals Ltd | Drugs | India |
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 | 62 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 32 |
| 21 CFR 117.135(a)(1) | Sanitation preventive controls - Implement | 21 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 21 |
| 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard | 20 |
| 21 CFR 1.506(e)(1) | Verification activity before import, periodically | 19 |
| 21 CFR 117.35(c) | Pest control | 17 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 17 |
| 21 CFR 117.10 | Personnel | 16 |
| 21 CFR 211.192 | Written record of investigation incomplete | 16 |
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 29, 2023 | Biomic Sciences, LLC Dba ION Intelligence Of Nature | Drugs | Microbial contamination of Non-Sterile Products |
| Sep 29, 2023 | Bix Produce Company LLC | Food | Cantaloupe may be contaminated with Salmonella. |
| Sep 28, 2023 | Covidien | Devices | Defective video laryngoscopes that did not pass quality tests established for the product, that were designated for destruction, were… |
| Sep 28, 2023 | Orgain | Food | Undeclared allergen; sesame |
| Sep 27, 2023 | Cookies-N-Milk Incorporated | Food | Undeclared Peanut Butter; Packaged Peanut Butter Dough in Chocolate Chip packaging. |
| Sep 27, 2023 | Medtronic Navigation, Inc. | Devices | Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergens: Milk, tree nuts, peanuts, and soy. Undeclared color additives: FD&C yellow #5, yellow #6, red #40. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergens: Milk and tree nut. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergens: Milk, tree nut, soy, and wheat. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergen: Milk. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergen: Milk. Undeclared color additives: FD&C red #5, red #6, blue #1, blue #5, blue #6. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergen: Milk. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergen: Milk. Undeclared color additives: FD&C yellow #5, blue #1, red #40. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergen: Milk. Undeclared color additives: FD&C yellow #5, yellow #6, red #40. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergens: Milk and Tree Nuts. Undeclared color additives: FD&C yellow #5, blue #1. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergen: Milk. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergens: Milk and soy. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergens: Milk, tree nuts, peanuts, and soy. Undeclared color additives: FD&C yellow #5, yellow #6, red #40. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergens: Milk, Tree Nuts, Peanuts, and Soy. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergen: Milk. Undeclared color additives: FD&C yellow #5, yellow #8, red #40. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergen: Milk. Undeclared color additives: FD&C yellow #5, yellow #6, red #40. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergens: Milk, peanuts, and soy. Undeclared color additive: FD&C blue #1, blue #2, red #3. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergen: Milk, tree nuts, peanuts, soy, and wheat. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergens: Milk, Tree Nuts, Peanuts, Soy and Wheat. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergen: Milk, tree nuts, peanuts, and soy. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergen: Milk. Undeclared color additives: FD&C yellow #5, yellow #8, red #40. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergens: Milk and tree nuts. Undeclared color additive: FD&C blue #1. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergen: Milk. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergen: Milk. Undeclared colors: FD&C yellow #5, red #40, blue #1. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergens: Milk and Tree Nuts. Undeclared color additives: FD&C yellow #5, blue #1, red #40, red#6, red #5. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergens: Milk, Peanuts, Soy, and Wheat. Undeclared color additives: FD&C red #40, red #6. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergen: Milk. Undeclared color additives: FD&C red #5, red #6, red #40, yellow #5. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergen: Milk. Undeclared color additives: FD&C red #40, red #6, red #5, yellow #5. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergen: Milk. Undeclared color additives: FD&C red #40, red #6, red #5, blue #1, and yellow #5. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergen: Milk. Undeclared color additives: FD&C red #6, red #5, yellow#5. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergens: Milk, peanut, soy, and wheat. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergens: Milk, soy, and wheat. Undeclared color additives: FD&C yellow #5, blue #1, red #40. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergen: Milk. Undeclared color additives: FD&C yellow #5, yellow #6, red #40. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergen: Milk, soy, and wheat. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergen: Milk. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergens: Milk, soy, and wheat. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergens: Milk and Tree Nuts. Undeclared color additives: FD&C yellow #5, yellow #8, red #40. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergen: Milk. Undeclared Color Additives: FD&C red #5, blue #1, red #3, red #40, yellow #5. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergen: Milk, tree nuts, peanuts, soy, and wheat. |
| Sep 27, 2023 | Paradise Flavors LLC | Food | Undeclared allergen: Milk. Undeclared color additives: FD&C yellow #5, yellow #6, red #40. |
| Sep 26, 2023 | Cordis US Corp | Devices | Non-sterile product labeled as sterile was distributed. |
| Sep 25, 2023 | Comercializadora Pepsico Mexico, | Food | Undeclared Allergen: Soy |
| Sep 25, 2023 | Dick Taylor Inc | Food | Undeclared allergen (peanut) |
| Sep 25, 2023 | Scynexis, Inc. | Drugs | Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a… |
| Sep 22, 2023 | Eagle Produce LLC, Dba Martori Farms | Food | Possible contamination with Salmonella spp. |
| Sep 22, 2023 | Olympus Corporation Of The Americas | Devices | There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were… |
| Sep 21, 2023 | B. Braun Medical, Inc. | Devices | Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk… |
| Sep 21, 2023 | B. Braun Medical, Inc. | Devices | Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk… |
| Sep 21, 2023 | Kula Brands LLC | Food | Undeclared Allergens: Milk and Tree Nut (Coconut) and Unapproved Food Additive: Kratom |
| Sep 20, 2023 | Cardinal Health 200, LLC | Devices | Demonstrated recognition and compatibility issues with syringe infusion pumps. |
| Sep 20, 2023 | Cardinal Health 200, LLC | Devices | Demonstrated recognition and compatibility issues with syringe infusion pumps. |
| Sep 20, 2023 | Cardinal Health 200, LLC | Devices | Demonstrated recognition and compatibility issues with syringe infusion pumps. |
| Sep 20, 2023 | Cardinal Health 200, LLC | Devices | Demonstrated recognition and compatibility issues with syringe infusion pumps. |
| Sep 20, 2023 | Cardinal Health 200, LLC | Devices | Demonstrated recognition and compatibility issues with syringe infusion pumps. |
| Sep 20, 2023 | Cardinal Health 200, LLC | Devices | Demonstrated recognition and compatibility issues with syringe infusion pumps. |
| Sep 20, 2023 | KVK-Tech, Inc. | Drugs | Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles. |
| Sep 20, 2023 | La Perla Inc | Food | Undeclared Allergen - Sesame |
| Sep 15, 2023 | Asensus Surgical Inc | Devices | Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Surgical System. This issue presented itself… |
| Sep 15, 2023 | CareFusion 303, Inc. | Devices | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been… |
| Sep 15, 2023 | CareFusion 303, Inc. | Devices | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been… |
| Sep 15, 2023 | CareFusion 303, Inc. | Devices | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been… |
| Sep 15, 2023 | Tama Corporation | Food | Undeclared Allergens: Wheat, Soy, Yellow #5 |
| Sep 13, 2023 | ResMed Ltd. | Devices | If ventilator is on internal battery, not intended to serve as a primary power source, low/critically low battery alarms will sound, but a… |
| Sep 12, 2023 | Knickerbocker 365 Inc. | Food | Undeclared milk |
| Sep 12, 2023 | The Kitchen Garden Co, LLC | Food | Undeclared allergen; egg |
| Sep 12, 2023 | The Kitchen Garden Co, LLC | Food | Undeclared allergen; egg |
| Sep 12, 2023 | The Kitchen Garden Co, LLC | Food | Undeclared allergen; egg |
| Sep 12, 2023 | The Kitchen Garden Co, LLC | Food | Undeclared allergen; egg |
| Sep 12, 2023 | The Kitchen Garden Co, LLC | Food | Undeclared allergen; egg |
| Sep 11, 2023 | EITAN MEDICAL LTD | Devices | Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism. |
| Sep 8, 2023 | Church & Dwight Inc | Drugs | Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis |
| Sep 8, 2023 | Novartis Pharmaceuticals Corp. | Drugs | Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals. |
| Sep 6, 2023 | Fresenius Medical Care Holdings, Inc. | Devices | Potential PCBA leaching from tubing of hemodialysis machines. |
| Sep 6, 2023 | Fresenius Medical Care Holdings, Inc. | Devices | Potential PCBA leaching from tubing of hemodialysis machines. |
| Sep 6, 2023 | Fresenius Medical Care Holdings, Inc. | Devices | Potential PCBA leaching from tubing of hemodialysis machines. |
| Sep 6, 2023 | Fresenius Medical Care Holdings, Inc. | Devices | Potential PCBA leaching from tubing of hemodialysis machines. |
| Sep 6, 2023 | Fresenius Medical Care Holdings, Inc. | Devices | Potential PCBA leaching from tubing of hemodialysis machines. |
| Sep 6, 2023 | Fresenius Medical Care Holdings, Inc. | Devices | Potential PCBA leaching from tubing of hemodialysis machines. |
| Sep 6, 2023 | Fresenius Medical Care Holdings, Inc. | Devices | Potential PCBA leaching from tubing of hemodialysis machines. |
| Sep 6, 2023 | Fresenius Medical Care Holdings, Inc. | Devices | Potential PCBA leaching from tubing of hemodialysis machines. |
| Sep 6, 2023 | Fresh Unlimited Inc | Food | Potential contamination of Listeria monocytogenes |
| Sep 5, 2023 | Life Raft Treats Ice Cream Factory | Food | South Carolina Department of Health discovered the product contained Listeria monocytogenes. |
| Sep 5, 2023 | Life Raft Treats Ice Cream Factory | Food | South Carolina Department of Health discovered the product contained Listeria monocytogenes. |
| Sep 5, 2023 | OBC GROUP CORP | Food | Product appears to be Yellow Oleander instead of Nuez de la India as labeled. |
| Sep 5, 2023 | OBC GROUP CORP | Food | Product appears to be Yellow Oleander instead of Nuez de la India as labeled. |
| Sep 1, 2023 | CenSea Inc | Food | Product tested positive for Salmonella |
| Sep 1, 2023 | Sheng Kee Of California, Inc Dba Sheng Kee Bakery | Food | Undeclared allergen; egg. |
| Sep 1, 2023 | Sheng Kee Of California, Inc Dba Sheng Kee Bakery | Food | Undeclared allergen; egg. |
| Sep 1, 2023 | Sheng Kee Of California, Inc Dba Sheng Kee Bakery | Food | Undeclared allergen; egg. |
| Sep 1, 2023 | Sheng Kee Of California, Inc Dba Sheng Kee Bakery | Food | Undeclared allergen; egg. |
| Sep 1, 2023 | Sheng Kee Of California, Inc Dba Sheng Kee Bakery | Food | Undeclared allergen; egg. |
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.