FDA Warning Letters, 483s and Recalls: July 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 |
|---|---|---|---|
| Jul 30, 2021 | Ocho Rios-Miami, Inc. | Division of Human and Animal Food Operations East IV | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Jul 30, 2021 | Ole Smoky Candy Kitchen Factory | Office of Human and Animal Foods Operations-East | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions |
| Jul 29, 2021 | 1St Phorm LLC | Office of Human and Animal Food West Division II | Unapproved New Drugs/Misbranded |
| Jul 29, 2021 | Farmakeio Outsourcing LLC | Office of Pharmaceutical Quality Operations, Division II | Compounding Pharmacy/Adulterated Drug Products |
| Jul 29, 2021 | Lepu Medical Technology -Beijing- Co., Ltd. | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Jul 28, 2021 | Dr. Thomas Polucki Upper Cervical Chiropractic, Inc. | Center for Food Safety and Applied Nutrition | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Jul 28, 2021 | Nutrishus Brands, Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| Jul 27, 2021 | Roal Produce, Inc | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Jul 27, 2021 | Sanit Technologies, LLC Dba Durisan | Office of Pharmaceutical Quality Operations, Division II | CGMP/Finished Pharmaceuticals/Adulterated |
| Jul 26, 2021 | Lexion Medical LLC | Center for Devices and Radiological Health | Adulterated and Misbranded Products, including Products Related to Coronavirus Disease 2019 (COVID-19) |
| Jul 26, 2021 | Vivera Pharmaceuticals, Inc. | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Jul 26, 2021 | Vivera Pharmaceuticals, Inc. | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Jul 23, 2021 | TeaTaze, LLC | Office of Human and Animal Food- West Division II | New Drug/Misbranded |
| Jul 22, 2021 | Matthew 7:25 Inc Dba Thrive Pharmacy | Office of Pharmaceutical Quality Operations, Division II | Compounding Pharmacy/Adulterated Drug Products |
| Jul 22, 2021 | MB Solutions, LLC/BioSpectrum CBD | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| Jul 22, 2021 | YemenUSA Inc. | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) |
| Jul 20, 2021 | 2M Associates, Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Jul 20, 2021 | Brilliant Enterprises LLC | Office of Human and Animal Food Operations Division- East 6 | Unapproved New Drugs/Misbranded |
| Jul 20, 2021 | Chill6 | Office of Human and Animal Food Operations East – Division 1 | Unapproved New Drugs/Misbranded |
| Jul 20, 2021 | Jordan’S Crossing Herbal Connections | Center for Drug Evaluation and Research | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Jul 20, 2021 | Rxmedkart.Com | Center for Drug Evaluation and Research | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Jul 19, 2021 | MasterPharm LLC | Division of Pharmaceutical Quality Operations I | Compounding Pharmacy/Adulterated Drug Products |
| Jul 16, 2021 | Transu Investment Group, LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Jul 15, 2021 | Sck Zeta Dis Ticaret, Pazarlama Ltd. | Center for Drug Evaluation and Research | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Jul 13, 2021 | Sayar Food Market, Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Jul 12, 2021 | Acme Smoked Fish Corp. | Office of Human and Animal Food Operations - East Division 1 | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Jul 12, 2021 | Beeyoutiful.Com, LLC | Office of Human and Animal Food Operations-East | New Drug/Misbranded |
| Jul 12, 2021 | Mario Hidalgo DBA Distribuidora De Productos Alimenticios El Paisita | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Jul 9, 2021 | Biopolygen Corp. | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Jul 9, 2021 | USH Diagnostics, Inc./Covidinstanttest.Net | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Jul 8, 2021 | 3RD Day Nutraceuticals, LLC | Office of Human and Animal Food Operations East – Division 1 | New Drug/Misbranded |
| Jul 8, 2021 | Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated |
| Jul 7, 2021 | Halodine, LLC | Center for Drug Evaluation and Research | Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19) |
| Jul 7, 2021 | Panjin Hetian Food Co., Ltd. | Center for Food Safety and Applied Nutrition | CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Jul 6, 2021 | Guangzhou Minghui Cosmetics Co., Ltd. | Center for Drug Evaluation and Research | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Jul 6, 2021 | Syntec Pharma Corp | Office of Pharmaceutical Quality Operations Division I | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Jul 2, 2021 | Captain's Cloth LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Jul 1, 2021 | Biomedical Research Laboratories, LLC | Office of Human and Animal Food Operations –West Division 5 | New Drug/Misbranded |
| Jul 1, 2021 | Dream Pharmacy 24/7 Enterprises Limited 2018 | Center for Drug Evaluation and Research | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Jul 1, 2021 | Phoenix Nutritionals, Inc. | Office of Human and Animal Food Operations-West Division 5 | New Drug/Misbranded |
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 30, 2021 | Global Medical Production Co Ltd | Devices | China |
| Jul 30, 2021 | Jim Bootsma Jr. Dairy LP | Veterinary | United States |
| Jul 30, 2021 | Nutritional Sales And Customer Service, LLC | Food/Cosmetics | United States |
| Jul 30, 2021 | Swan Brothers Dairy Inc | Food/Cosmetics | United States |
| Jul 30, 2021 | Unetixs Vascular, Inc. | Devices | United States |
| Jul 29, 2021 | Lymol Medical Corporation | Devices | United States |
| Jul 29, 2021 | Nature's Supplements, Inc. | Food/Cosmetics | United States |
| Jul 29, 2021 | Onofrio's Fresh Cut, Inc. | Food/Cosmetics | United States |
| Jul 28, 2021 | Generitech Corporation | Drugs | United States |
| Jul 28, 2021 | Global Vitality Inc. | Food/Cosmetics | United States |
| Jul 27, 2021 | Med Shop Total Care Inc. | Drugs | United States |
| Jul 26, 2021 | Colonia Care Pharmacy | Drugs | United States |
| Jul 26, 2021 | D & C Seafood, Inc. | Food/Cosmetics | United States |
| Jul 26, 2021 | Richard J. Obiso, PhD | Drugs | United States |
| Jul 23, 2021 | OFP Ingredients LLC | Food/Cosmetics | United States |
| Jul 23, 2021 | Private Label Select Ltd. Co. | Drugs | United States |
| Jul 21, 2021 | DNA Distributors, INC | Tobacco | United States |
| Jul 21, 2021 | Kwokcheng Enterprise, Inc. | Food/Cosmetics | United States |
| Jul 20, 2021 | Foodworks International LLC | Food/Cosmetics | United States |
| Jul 19, 2021 | Cross Brands Contract Filling, LLC | Drugs | United States |
| Jul 19, 2021 | Lohxa LLC | Drugs | United States |
| Jul 19, 2021 | The Vapor Craft LLC | Tobacco | United States |
| Jul 16, 2021 | Lempira Distribution Llc | Food/Cosmetics | United States |
| Jul 16, 2021 | ProFresh International Corp. | Drugs | United States |
| Jul 15, 2021 | Gold Star Feed & Grain, LLC | Veterinary | United States |
| Jul 15, 2021 | New Capstone, Inc | Food/Cosmetics | United States |
| Jul 14, 2021 | H&C Food Inc. | Food/Cosmetics | United States |
| Jul 14, 2021 | Spectrum Laboratory Products, Inc. | Drugs | United States |
| Jul 13, 2021 | DynaPro International, Inc. | Food/Cosmetics | United States |
| Jul 12, 2021 | Sarita's Tortilla Factory, Inc | Food/Cosmetics | United States |
| Jul 12, 2021 | The Grateful Bread, Inc. | Food/Cosmetics | United States |
| Jul 9, 2021 | Muscle Sport Products LLC | Food/Cosmetics | United States |
| Jul 9, 2021 | Ocho Rios-Miami, Inc. | Food/Cosmetics | United States |
| Jul 8, 2021 | CBI Laboratories, Inc. | Drugs | United States |
| Jul 8, 2021 | CellEra LLC | Devices | United States |
| Jul 8, 2021 | Handylee Enterprises (USA) Corp. | Food/Cosmetics | United States |
| Jul 7, 2021 | Medtronic MiniMed, Inc. | Devices | United States |
| Jul 7, 2021 | V-NINE INC | Food/Cosmetics | United States |
| Jul 6, 2021 | Valisure, LLC | Drugs | United States |
| Jul 1, 2021 | Health Plus Incorporated | 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 | 89 |
| 21 CFR 117.35(c) | Pest control | 17 |
| 21 CFR 123.6(b) | No HACCP plan | 17 |
| 21 CFR 123.11(b) | Sanitation monitoring | 14 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 14 |
| 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls | 13 |
| 21 CFR 117.20(b) | Plant construction and design | 10 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 10 |
| 21 CFR 117.40 | Equipment and utensils - Design and maintenance | 10 |
| 21 CFR 1.505(a)(2) | Evaluation - performance, risk | 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 27, 2021 | Whole Foods Market | Food | Potential to be contaminated with Listeria monocytogenes |
| Jul 27, 2021 | Whole Foods Market | Food | Potential to be contaminated with Listeria monocytogenes |
| Jul 26, 2021 | CAHILLS FARM CHEESE LIMITED | Food | Cheese may be contaminated with Listeria monocytogenes. |
| Jul 26, 2021 | CAHILLS FARM CHEESE LIMITED | Food | Cheese may be contaminated with Listeria monocytogenes. |
| Jul 26, 2021 | CAHILLS FARM CHEESE LIMITED | Food | Cheese may be contaminated with Listeria monocytogenes. |
| Jul 26, 2021 | CAHILLS FARM CHEESE LIMITED | Food | Cheese may be contaminated with Listeria monocytogenes. |
| Jul 26, 2021 | CAHILLS FARM CHEESE LIMITED | Food | Cheese may be contaminated with Listeria monocytogenes. |
| Jul 26, 2021 | McCormick & Company - MSS - HQ | Food | Product may be contaminated with Salmonella. |
| Jul 26, 2021 | McCormick & Company - MSS - HQ | Food | Product may be contaminated with Salmonella. |
| Jul 26, 2021 | McCormick & Company - MSS - HQ | Food | Product may be contaminated with Salmonella. |
| Jul 21, 2021 | Cordis Corporation | Devices | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow… |
| Jul 21, 2021 | Cordis Corporation | Devices | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow… |
| Jul 21, 2021 | Cordis Corporation | Devices | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow… |
| Jul 21, 2021 | Cordis Corporation | Devices | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow… |
| Jul 21, 2021 | Cordis Corporation | Devices | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow… |
| Jul 21, 2021 | Old Souls Farms LLC | Food | Positive rainwater test for Listeria monocytogenes. The rainwater came in contact with product. |
| Jul 21, 2021 | Old Souls Farms LLC | Food | Positive rainwater test for Listeria monocytogenes. The rainwater came in contact with product. |
| Jul 21, 2021 | Old Souls Farms LLC | Food | Positive rainwater test for Listeria monocytogenes. The rainwater came in contact with product. |
| Jul 21, 2021 | Old Souls Farms LLC | Food | Positive rainwater test for Listeria monocytogenes. The rainwater came in contact with product. |
| Jul 21, 2021 | Old Souls Farms LLC | Food | Positive rainwater test for Listeria monocytogenes. The rainwater came in contact with product. |
| Jul 21, 2021 | Old Souls Farms LLC | Food | Positive rainwater test for Listeria monocytogenes. The rainwater came in contact with product. |
| Jul 19, 2021 | Grimmway Enterprises, Inc. Dba Grimmway Farms | Food | Carrot products may be contaminated with Salmonella |
| Jul 19, 2021 | Grimmway Enterprises, Inc. Dba Grimmway Farms | Food | Carrot products may be contaminated with Salmonella |
| Jul 19, 2021 | Grimmway Enterprises, Inc. Dba Grimmway Farms | Food | Carrot products may be contaminated with Salmonella |
| Jul 19, 2021 | Grimmway Enterprises, Inc. Dba Grimmway Farms | Food | Carrot products may be contaminated with Salmonella |
| Jul 19, 2021 | Grimmway Enterprises, Inc. Dba Grimmway Farms | Food | Carrot products may be contaminated with Salmonella |
| Jul 19, 2021 | Grimmway Enterprises, Inc. Dba Grimmway Farms | Food | Carrot products may be contaminated with Salmonella |
| Jul 19, 2021 | Grimmway Enterprises, Inc. Dba Grimmway Farms | Food | Carrot products may be contaminated with Salmonella |
| Jul 19, 2021 | Grimmway Enterprises, Inc. Dba Grimmway Farms | Food | Carrot products may be contaminated with Salmonella |
| Jul 16, 2021 | Alpha-Tek LLC | Drugs | Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil |
| Jul 16, 2021 | Lipari Foods Operating Company, LLC. | Food | Sulfites not disclosed on labeling |
| Jul 15, 2021 | Bright Farms | Food | Product may be contaminated with Salmonella. |
| Jul 15, 2021 | Bright Farms | Food | Product may be contaminated with Salmonella. |
| Jul 15, 2021 | Bright Farms | Food | Product may be contaminated with Salmonella. |
| Jul 15, 2021 | Bright Farms | Food | Product may be contaminated with Salmonella. |
| Jul 15, 2021 | Bright Farms | Food | Product may be contaminated with Salmonella. |
| Jul 15, 2021 | Bright Farms | Food | Product may be contaminated with Salmonella. |
| Jul 15, 2021 | Bright Farms | Food | Product may be contaminated with Salmonella. |
| Jul 15, 2021 | Bright Farms | Food | Product may be contaminated with Salmonella. |
| Jul 15, 2021 | Bright Farms | Food | Product may be contaminated with Salmonella. |
| Jul 15, 2021 | Bright Farms | Food | Product may be contaminated with Salmonella. |
| Jul 14, 2021 | Johnson & Johnson Consumer, Inc. | Drugs | Chemical Contamination: presence of benzene |
| Jul 14, 2021 | Johnson & Johnson Consumer, Inc. | Drugs | Chemical Contamination: presence of benzene |
| Jul 14, 2021 | Qikmoov LLC | Drugs | Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine. |
| Jul 13, 2021 | Micro Therapeutics Inc, | Devices | Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the… |
| Jul 13, 2021 | Micro Therapeutics Inc, | Devices | Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the… |
| Jul 7, 2021 | Baxter Healthcare Corporation | Devices | Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug… |
| Jul 5, 2021 | LSG SKY CHEFS | Food | The firm is recalling Circle K brand Chicken Salad Sandwiches "best buy" date of 6/7/21 through 7/9/21 because the chicken used is subject… |
| Jul 2, 2021 | Eillien's Candies, Inc. | Food | Dark Chocolate Amaretto Pecans contain undeclared almonds. |
| Jul 2, 2021 | KVK-Tech, Inc. | Drugs | Temperature abuse: the firm received customer complaints of unusual grittiness in the product. |
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