FDA Warning Letters, 483s and Recalls: July 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 |
|---|---|---|---|
| Jul 28, 2023 | Intas Pharmaceuticals Limited | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Jul 26, 2023 | Denison Pharmaceuticals, LLC | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated |
| Jul 26, 2023 | US Specialty Formulations, LLC | Division of Pharmaceutical Quality Operations I | Compounding Pharmacy/Adulterated Drug Products |
| Jul 25, 2023 | Baxter Healthcare Corporation | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Jul 25, 2023 | Centaur Pharmaceuticals Private Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Jul 24, 2023 | BC Food LA, LLC, DBA B & C Food Co. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Jul 21, 2023 | Biosensors Interventional Technologies Pte Ltd | OHT2: Office of Cardiovascular Devices, Office of Product Evaluation and Quality | Medical Device Reporting/Misbranded |
| Jul 21, 2023 | Gadget Island, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| Jul 21, 2023 | STC India Private Limited | Center for Food Safety and Applied Nutrition (CFSAN) | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Jul 20, 2023 | Iso-Tex Diagnostics, Inc. | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated |
| Jul 20, 2023 | Medgel Private Limited | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Jul 20, 2023 | Wise Women’S Choice | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| Jul 19, 2023 | La Yongjia Trade Co. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Jul 18, 2023 | Avlon Industries, Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated |
| Jul 18, 2023 | Del Valle Import & Export 3, Inc. DBA El Progreso Imports | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Jul 18, 2023 | Koi CBD, LLC | Division of Human and Animal Food Operations West V | Adulterated Human Foods/Misbranded |
| Jul 17, 2023 | Integra LifeSciences Corporation | Division of Medical Device and Radiological Health Division I | CGMP/QSR/Medical Devices/Adulterated |
| Jul 17, 2023 | LXR Biotech, LLC | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated |
| Jul 14, 2023 | Premier Food Supplies LLC | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) |
| Jul 13, 2023 | Jamol Laboratories, Inc. | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated |
| Jul 10, 2023 | Chean Industries Dominicana S.R.L. | Center for Food Safety and Applied Nutrition | Seafood HACCP/CGMP for Foods/Adulterated |
| Jul 7, 2023 | Northland Vapor Company, LLC | Division of Human and Animal Food Operations West I | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Jul 6, 2023 | Bella Mia Foods, Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Jul 6, 2023 | C K Frozen Fish And Food Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Jul 5, 2023 | Outset Medical, Inc. | Center for Devices and Radiological Health | Premarket Approval/Adulterated |
| Jul 3, 2023 | Sunshine Trading Company, Inc. Dba Nova Tea And Nova Kratom | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs |
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 |
|---|---|---|---|
| Jul 31, 2023 | 5000 Years Foods, Inc. | Food/Cosmetics | United States |
| Jul 31, 2023 | Central Admixture Pharmacy Services, Inc. | Drugs | United States |
| Jul 28, 2023 | Cooperstown Cheese Company, LLC | Food/Cosmetics | United States |
| Jul 28, 2023 | Empacadora Bilbo S.A. | Food/Cosmetics | Ecuador |
| Jul 28, 2023 | OMEZA LLC | Drugs | United States |
| Jul 27, 2023 | Deymed Diagnostic S.R.O. | Devices | Czech Republic |
| Jul 27, 2023 | Williams & Son Livestock, LLC. | Veterinary | United States |
| Jul 26, 2023 | Grandma's Herbs, Inc. | Food/Cosmetics | United States |
| Jul 26, 2023 | Louisiana State University Health Sciences Center IRB | Devices | United States |
| Jul 26, 2023 | Mina Global Trading Corp | Food/Cosmetics | United States |
| Jul 25, 2023 | Euro USA Inc | Food/Cosmetics | United States |
| Jul 24, 2023 | Advanced Cosmetic Research Laboratories, Inc. | Drugs | United States |
| Jul 21, 2023 | Hubbly Bubbly LLC | Tobacco | United States |
| Jul 21, 2023 | INDIAN GROCERIES AND SPICES INC | Food/Cosmetics | United States |
| Jul 21, 2023 | S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED | Drugs | Thailand |
| Jul 20, 2023 | Ohm Centric Coils LLC | Tobacco | United States |
| Jul 20, 2023 | Sweis Global LLC | Tobacco | United States |
| Jul 19, 2023 | DHL Supply Chain RN (USA) LLC | Drugs | United States |
| Jul 19, 2023 | Naturavit Inc | Food/Cosmetics | United States |
| Jul 18, 2023 | Dextrum Laboratories | Drugs | United States |
| Jul 18, 2023 | Product Packaging West, Inc. | Drugs | United States |
| Jul 18, 2023 | SAN-REY PRODUCE | Food/Cosmetics | United States |
| Jul 17, 2023 | Ocho Rios-Miami, Inc. | Food/Cosmetics | United States |
| Jul 14, 2023 | AmLion Toothpaste Mfg Sdn | Drugs | Malaysia |
| Jul 14, 2023 | Freshy Foods, LLC | Food/Cosmetics | United States |
| Jul 14, 2023 | Preservation Solutions, Inc. | Devices | United States |
| Jul 14, 2023 | Tugusto Foods, Inc. | Food/Cosmetics | United States |
| Jul 13, 2023 | GOLDEN NATURAL PRODUCTS INC | Food/Cosmetics | United States |
| Jul 13, 2023 | Northland Nuclear Medicine, LLC | Drugs | United States |
| Jul 10, 2023 | COLIMAN PRODUCE INC | Food/Cosmetics | United States |
| Jul 8, 2023 | Cali Rice Valley, Inc. | Food/Cosmetics | United States |
| Jul 7, 2023 | BE Pharmaceuticals Private Ltd. | Drugs | India |
| Jul 7, 2023 | Shantaba LLC | Food/Cosmetics | United States |
| Jul 7, 2023 | Surgery Pharmacy Services Inc | Drugs | United States |
| Jul 5, 2023 | New Vitalis Pharmacy LLC | 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) | Develop FSVP | 72 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 26 |
| 21 CFR 117.35(c) | Pest control | 23 |
| 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls | 20 |
| FDCA 501(a)(2)(A) | Use of non-pharmaceutical, ingredients/processing aides | 19 |
| 21 CFR 117.10 | Personnel | 16 |
| 21 CFR 1.505(a)(2) | Evaluation - performance, risk | 16 |
| 21 CFR 117.135(a)(1) | Sanitation preventive controls - Implement | 15 |
| 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard | 12 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 10 |
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 |
|---|---|---|---|
| Jul 31, 2023 | Datascope Corp. | Devices | Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode. |
| Jul 31, 2023 | Datascope Corp. | Devices | Users were identifying autofill failure conditions on the devices causing pump stops. |
| Jul 31, 2023 | Datascope Corp. | Devices | Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal… |
| Jul 31, 2023 | Datascope Corp. | Devices | Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal… |
| Jul 31, 2023 | Datascope Corp. | Devices | Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console… |
| Jul 31, 2023 | Datascope Corp. | Devices | Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode. |
| Jul 31, 2023 | Datascope Corp. | Devices | Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console… |
| Jul 31, 2023 | Datascope Corp. | Devices | Users were identifying autofill failure conditions on the devices causing pump stops. |
| Jul 26, 2023 | Hamilton Medical, Inc. | Devices | Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short… |
| Jul 26, 2023 | Hamilton Medical, Inc. | Devices | Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short… |
| Jul 26, 2023 | Hamilton Medical, Inc. | Devices | Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short… |
| Jul 26, 2023 | Hamilton Medical, Inc. | Devices | Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short… |
| Jul 26, 2023 | Hamilton Medical, Inc. | Devices | Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short… |
| Jul 26, 2023 | Hamilton Medical, Inc. | Devices | Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short… |
| Jul 24, 2023 | Rich Products Corp | Food | Product contains undeclared egg and soy. |
| Jul 19, 2023 | Richin Trading Inc | Food | Undeclared allergens; soy and wheat |
| Jul 18, 2023 | Abbott Medical | Devices | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse… |
| Jul 18, 2023 | Abbott Medical | Devices | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse… |
| Jul 18, 2023 | Abbott Medical | Devices | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse… |
| Jul 18, 2023 | Abbott Medical | Devices | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse… |
| Jul 18, 2023 | Abbott Medical | Devices | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse… |
| Jul 18, 2023 | Abbott Medical | Devices | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse… |
| Jul 18, 2023 | Abbott Medical | Devices | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse… |
| Jul 15, 2023 | Cava Foods LLC | Food | Undeclared sesame |
| Jul 14, 2023 | ONO LLC | Food | Undeclared milk |
| Jul 13, 2023 | Heinens | Food | Undeclared Allergens: Possible Peanut Butter and/or Almond Butter mixed into Cashew Butter container. |
| Jul 12, 2023 | Draeger Medical, Inc. | Devices | Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during… |
| Jul 10, 2023 | Braga Fresh Foods | Food | Undeclared milk and egg |
| Jul 6, 2023 | Betty Lou's Inc | Food | Undeclared sesame. Paleo Java Nuts About Energy Balls with Cacao, Coffee & Pumpkin Seeds product containing sesame was packaged and labeled… |
| Jul 3, 2023 | US Waffle Company, INC. | Food | The firm was notified, by a consumer, that the product contains undeclared Wheat. |
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