FDA Warning Letters, 483s and Recalls: February 2021
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 |
|---|---|---|---|
| Feb 26, 2021 | Orvic Dba Webstore-USA | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Feb 25, 2021 | Inovaker Lab S.A. De C.V. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Feb 22, 2021 | Asesores En Mantenimiento Hidraulico E Industrial, S.A. De C.V. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Feb 22, 2021 | Yara Elena De La Garza Perez Nieto | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Feb 19, 2021 | Richardson Nutritional Center, LLC/Nutriseeds, Inc. | Office of Human and Animal Food Operations-West Division 5 | New Drug/Misbranded |
| Feb 18, 2021 | Absara Cosmetics S.A.P.I DE C.V. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Feb 18, 2021 | B4B Corp. | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Feb 18, 2021 | Blossom Nature, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| Feb 18, 2021 | Dr. Garber’S Natural Solutions | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| Feb 18, 2021 | Enlifta, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| Feb 18, 2021 | FDC Nutrition Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| Feb 18, 2021 | Lifted Naturals | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| Feb 18, 2021 | Mercola.Com, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Feb 18, 2021 | Mountain Peak Nutritionals | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| Feb 18, 2021 | Native Remedies Dba Silver Star Brands | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| Feb 18, 2021 | ProHealth Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| Feb 18, 2021 | SafaLab, Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Feb 18, 2021 | SANA Group LLC | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| Feb 18, 2021 | Wholesome Wellness | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| Feb 16, 2021 | Dr. Paul's Lab | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Feb 16, 2021 | KDunn And Associates, P.A. Dba HealthQuilt | Center for Drug Evaluation and Research | CDER | Clinical Investigator |
| Feb 12, 2021 | CooperSurgical, Inc. | The Office of Prescription Drug Promotion (OPDP) | False & Misleading Claims/Misbranded |
| Feb 11, 2021 | AcelRx Pharmaceuticals, Inc. | The Office of Prescription Drug Promotion (OPDP) | False & Misleading Claims/Misbranded |
| Feb 11, 2021 | Evolved Ayurvedic Discoveries, Inc./BioCBDPlus | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Feb 5, 2021 | Precision Analitica Integral S.A. De C.V. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Feb 3, 2021 | AAA Cosmetica, SA De CV | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Feb 3, 2021 | Botanicals Internacional S.A. De C.V. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Feb 3, 2021 | JR & Son World Trading LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Feb 3, 2021 | My Habitat Brands LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Feb 3, 2021 | ShangRao Chunyu Technology Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Feb 2, 2021 | Clarke Pharmaceutical Manufacturing, Inc. | Division of Human and Animal Food Operations West III | Unapproved New Drugs/Misbranded |
| Feb 2, 2021 | Marci Beauty LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Feb 1, 2021 | Hawaii Health Systems Corporation Dba Kona Community Hospital Pharmacy | Division of Pharmaceutical Quality Operations IV | Compounding Pharmacy/Adulterated Drug Products |
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 |
|---|---|---|---|
| Feb 26, 2021 | Dechoker, LLC | Devices | United States |
| Feb 25, 2021 | Atlantic Bakery Ltd. | Food/Cosmetics | United States |
| Feb 25, 2021 | Modesto Food Distributors, Inc. | Food/Cosmetics | United States |
| Feb 25, 2021 | Toyobo Co. Ltd. | Drugs | Japan |
| Feb 24, 2021 | IDC USA INC | Food/Cosmetics | United States |
| Feb 22, 2021 | MnM Spices Corporation | Food/Cosmetics | United States |
| Feb 12, 2021 | Martinez Mexican Produce Llc | Food/Cosmetics | United States |
| Feb 11, 2021 | Utah Cord Bank LLC | Biologics | United States |
| Feb 10, 2021 | Acme Smoked Fish Corp. | Food/Cosmetics | United States |
| Feb 9, 2021 | MCELROY IMPORTS | Food/Cosmetics | United States |
| Feb 5, 2021 | Midwestern Pet Foods Chickasha Operation | Veterinary | United States |
| Feb 3, 2021 | Selamta LLC | Food/Cosmetics | United States |
| Feb 1, 2021 | Promex Distribution LLC | 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) | Develop FSVP | 62 |
| 21 CFR 1.506(a)(1) | Unapproved supplier procedures - importer established | 9 |
| 21 CFR 1.504(a) | Hazard analysis written | 7 |
| 21 CFR 1.506(b) | Supplier verification - establish written procedures | 7 |
| 21 CFR 117.130(a)(1) | Hazard Analysis - Identification of Hazard | 6 |
| 21 CFR 117.145(a) | Process Controls Monitoring Procedures: Establish Implement | 5 |
| 21 CFR 117.165(b) | Sanitation Controls Verif Procedures: Establish Implement | 5 |
| 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls | 5 |
| 21 CFR 1.505(b) | Supplier approval - document | 5 |
| 21 CFR 1.506(d)(1)(i) | Verification activity frequency | 5 |
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 |
|---|---|---|---|
| Feb 27, 2021 | Nutrin Distribution Co | Food | Possible Salmonella contamination in roasted peanut splits |
| Feb 26, 2021 | Heartware, Inc. | Devices | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor… |
| Feb 26, 2021 | Heartware, Inc. | Devices | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor… |
| Feb 26, 2021 | Heartware, Inc. | Devices | Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regarding: Carrying Cases, Driveline Cover… |
| Feb 26, 2021 | Heartware, Inc. | Devices | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor… |
| Feb 26, 2021 | Heartware, Inc. | Devices | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor… |
| Feb 26, 2021 | Heartware, Inc. | Devices | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor… |
| Feb 26, 2021 | Heartware, Inc. | Devices | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor… |
| Feb 26, 2021 | STEP-HAR MEDICAL LLC | Devices | Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking… |
| Feb 25, 2021 | BioMedical Equipment Service Co (BMES) | Devices | Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking… |
| Feb 25, 2021 | KAREEM MART INC | Food | Product tested positive for Salmonella. |
| Feb 25, 2021 | Tenacore LLC | Devices | Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking… |
| Feb 25, 2021 | Tenacore LLC | Devices | Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking… |
| Feb 24, 2021 | Mediterranean Food, Inc. | Food | Product tested positive for Salmonella. |
| Feb 19, 2021 | Seafood Imports Distributors Inc. | Food | FDA Sample found Salmonella in one lot of 10 oz. frozen tuna steaks. |
| Feb 18, 2021 | Smisson-Cartledge Biomedical, LLC | Devices | Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed… |
| Feb 18, 2021 | Smisson-Cartledge Biomedical, LLC | Devices | Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed… |
| Feb 18, 2021 | Smisson-Cartledge Biomedical, LLC | Devices | Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed… |
| Feb 18, 2021 | Zydus Pharmaceuticals (USA) Inc | Drugs | Crystallization: customer complaints for crystallization in finished product. |
| Feb 18, 2021 | Zydus Pharmaceuticals (USA) Inc | Drugs | Crystallization: customer complaints for crystallization in finished product. |
| Feb 17, 2021 | El Abuelito Cheese, Inc. | Food | Product may be contaminated with Listeria monocytogenes. |
| Feb 17, 2021 | El Abuelito Cheese, Inc. | Food | Product may be contaminated with Listeria monocytogenes. |
| Feb 17, 2021 | El Abuelito Cheese, Inc. | Food | Product may be contaminated with Listeria monocytogenes. |
| Feb 15, 2021 | Adams.Secret.Co | Drugs | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil. |
| Feb 15, 2021 | Adams.Secret.Co | Drugs | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil. |
| Feb 12, 2021 | Medtronic Vascular, Inc. | Devices | Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement. |
| Feb 11, 2021 | Cordis Corporation | Devices | Distal tip may become separated from the lumen wire in specific lots. |
| Feb 11, 2021 | Thompson Brands LLC | Food | Products are potentially contaminated with Salmonella. |
| Feb 5, 2021 | Barbara's Orchard/Delicae Gourmet | Food | Undeclared allergen: Shrimp |
| Feb 5, 2021 | Barbara's Orchard/Delicae Gourmet | Food | Undeclared allergen: Shrimp |
| Feb 5, 2021 | Barbara's Orchard/Delicae Gourmet | Food | Undeclared allergen: Shrimp |
| Feb 5, 2021 | Harry And David Operations Inc | Food | undeclared cashews and almonds. |
| Feb 4, 2021 | Medtronic Perfusion Systems | Devices | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial… |
| Feb 4, 2021 | Medtronic Perfusion Systems | Devices | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial… |
| Feb 4, 2021 | Medtronic Perfusion Systems | Devices | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial… |
| Feb 4, 2021 | Medtronic Perfusion Systems | Devices | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial… |
| Feb 4, 2021 | Medtronic Perfusion Systems | Devices | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial… |
| Feb 4, 2021 | Medtronic Perfusion Systems | Devices | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial… |
| Feb 4, 2021 | Medtronic Perfusion Systems | Devices | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial… |
| Feb 4, 2021 | Medtronic Perfusion Systems | Devices | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial… |
| Feb 4, 2021 | Medtronic Perfusion Systems | Devices | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial… |
| Feb 4, 2021 | Medtronic Perfusion Systems | Devices | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial… |
| Feb 3, 2021 | Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF) | Devices | A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT)… |
| Feb 3, 2021 | Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF) | Devices | A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT)… |
| Feb 2, 2021 | Apotex Corp. | Drugs | Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL… |
| Feb 2, 2021 | Apotex Corp. | Drugs | Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL… |
| Feb 2, 2021 | Ohio Hickory Harvest Brand Products, Inc. | Food | Undeclared Allergen of Tree Nuts : Almonds |
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