FDA Warning Letters, 483s and Recalls: April 2018
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.
No warning letters outside tobacco are recorded for this month yet.
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 |
|---|---|---|---|
| Apr 27, 2018 | Coupler LLC | Drugs | United States |
| Apr 27, 2018 | Dr Marcs Manufacturing And Sales, LLC | Drugs | United States |
| Apr 27, 2018 | Hangzhou Zhongbo Industrial Co., Ltd. | Drugs | China |
| Apr 26, 2018 | Caviar Petrossian S. A. | Food/Cosmetics | France |
| Apr 23, 2018 | Best Nutrition Products, Inc. | Food/Cosmetics | United States |
| Apr 23, 2018 | MIG Acquisition | Veterinary | United States |
| Apr 23, 2018 | Roorda Dairy, LLC | Veterinary | United States |
| Apr 23, 2018 | Zhengzhou Minzhong Pharmaceutical Co., Ltd. | Drugs | China |
| Apr 20, 2018 | Centrient Pharmaceuticals India Private Limited | Drugs | India |
| Apr 20, 2018 | Hangzhou Guoguang Touring Commodity Co.,Ltd. | Drugs | China |
| Apr 20, 2018 | JMA Partners | Drugs | United States |
| Apr 20, 2018 | Longbow First Aid Products Manufactory | Drugs | China |
| Apr 19, 2018 | Anigan, Inc. | Devices | United States |
| Apr 19, 2018 | Tissue Transplant Technology, Ltd. | Biologics | United States |
| Apr 17, 2018 | Nathan's Soup And Salad Henrietta Inc. | Food/Cosmetics | United States |
| Apr 16, 2018 | Distribuidora La Jugosita, Inc. | Food/Cosmetics | United States |
| Apr 16, 2018 | Nusmile, Ltd. | Devices | United States |
| Apr 13, 2018 | New Era Naturals | Drugs | United States |
| Apr 13, 2018 | RIJ Pharmaceutical LLC | Drugs | United States |
| Apr 13, 2018 | Uptown Research Institute | Drugs | United States |
| Apr 12, 2018 | La Sonorense, Inc. | Food/Cosmetics | United States |
| Apr 12, 2018 | Viatris, Inc. | Drugs | United States |
| Apr 11, 2018 | Pharmedium Services, LLC | Drugs | United States |
| Apr 11, 2018 | Rose Acre Farms Inc. - Hyde County Egg Farm | Food/Cosmetics | United States |
| Apr 11, 2018 | Zhejiang Haisen Pharmaceutical Co., Ltd. | Veterinary | China |
| Apr 9, 2018 | Clark Seafood Co, Inc | Food/Cosmetics | United States |
| Apr 6, 2018 | Avicola Santos, Inc. | Food/Cosmetics | United States |
| Apr 6, 2018 | Tubilux Pharma Spa | Drugs | Italy |
| Apr 6, 2018 | United Exchange Corp. | Drugs | United States |
| Apr 6, 2018 | United Exchange Corporation | Drugs | United States |
| Apr 5, 2018 | EL MAGUEY DORADO CORPORATION | Food/Cosmetics | United States |
| Apr 4, 2018 | Delano Company, Inc. | Food/Cosmetics | United States |
| Apr 4, 2018 | Independent Nutrition, Inc. | Food/Cosmetics | United States |
| Apr 3, 2018 | Gland Chemicals Private Limited | Drugs | India |
| Apr 3, 2018 | Healthy Healing Enterprises Inc. | 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 117.35(a) | Sanitary operations - Plant sanitation | 25 |
| FDCA 402(a)(4) | Records review prior to shipment for slaughter | 25 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 24 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 22 |
| 21 CFR 117.80(c) | Process Control Measures | 17 |
| 21 CFR 123.11(b) | Sanitation monitoring documentation | 17 |
| 21 CFR 117.40 | Equipment and utensils - Design and maintenance | 16 |
| 21 CFR 211.192 | Written record of investigation incomplete | 16 |
| 21 CFR 123.6(b) | No HACCP plan | 14 |
| 21 CFR 211.22(d) | Procedures not in writing, fully followed | 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 |
|---|---|---|---|
| Apr 30, 2018 | Stonewall Kitchen, LLC | Food | Product may contain undeclared eggs. |
| Apr 27, 2018 | Tyson Foods Discovery Center | Food | The firm was notified that they failed to include the allergens milk & wheat in their ingredient statement. |
| Apr 26, 2018 | Ethnic Foods, Inc. D/B/A Bombay Kitchen Foods | Food | Product contains undeclared peanuts. |
| Apr 24, 2018 | Greenbelt Greenhouse Ltd | Food | Arugula Microgreens product is recalled due to a potential to be contaminated with Listeria monocytogenes. |
| Apr 24, 2018 | Greenbelt Greenhouse Ltd | Food | Broccoli Microgreens product is recalled due to a potential to be contaminated with Listeria monocytogenes. |
| Apr 24, 2018 | Greenbelt Greenhouse Ltd | Food | Fresh Microgreen Mix product is recalled due to a potential to be contaminated with Listeria monocytogenes. |
| Apr 24, 2018 | Greenbelt Greenhouse Ltd | Food | Pea Shoots Microgreens product is recalled due to a potential to be contaminated with Listeria monocytogenes. |
| Apr 24, 2018 | Greenbelt Greenhouse Ltd | Food | Sunflower Microgreens product is recalled due to a potential to be contaminated with Listeria monocytogenes. |
| Apr 24, 2018 | Greenbelt Greenhouse Ltd | Food | Spicy Microgreen Mix product is recalled due to a potential to be contaminated with Listeria monocytogenes. |
| Apr 24, 2018 | Greenbelt Greenhouse Ltd | Food | Sweet & Crunchy Microgreen Mix product is recalled due to a potential to be contaminated with Listeria monocytogenes. |
| Apr 24, 2018 | Labrada Nutrition, Inc | Food | Undeclared egg |
| Apr 24, 2018 | Labrada Nutrition, Inc | Food | Undeclared egg |
| Apr 24, 2018 | Labrada Nutrition, Inc | Food | Undeclared egg |
| Apr 20, 2018 | Eden's Ethnos, LLC | Food | FDA and state samples found Salmonella in Kratom products that traced back to Eden Ethnos LLC. |
| Apr 19, 2018 | Mccall Farms Inc | Food | Canned spinach is being recalled due to the potential to contain boiled peanuts instead of spinach. |
| Apr 18, 2018 | Superior Foods Company | Food | Superior Foods Company is voluntarily recalling a specific lot of Smoked Salmon Spreads that were produced on March 26, 2018, due to… |
| Apr 18, 2018 | Viable Solutions, LLC | Food | Mitragyna Speciosa Leaf Powder Red Vein Sumatra and Mitragyna Speciosa Leaf Powder Red Vein Bali Kratom products are being recalled… |
| Apr 18, 2018 | Viable Solutions, LLC | Food | Mitragyna Speciosa Leaf Powder Green Horn Kratom product is being recalled because they have the potential to be contaminated with… |
| Apr 18, 2018 | Viable Solutions, LLC | Food | Mitragyna Speciosa Leaf Powder Thai Maeng Da Kratom product is being recalled because they have the potential to be contaminated with… |
| Apr 16, 2018 | Epic Products, LLC | Drugs | Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxytetracycline, FDA approved drug products… |
| Apr 14, 2018 | Cal Maine Foods | Food | The firm was notified by their supplier that the product may contain Salmonella. |
| Apr 14, 2018 | EATALY NY, LLC (DUTY ONLY) | Food | Product contains undeclared walnuts. |
| Apr 13, 2018 | CareFusion 303, Inc. | Devices | The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time… |
| Apr 13, 2018 | Cheezwhse/Com | Food | Product may be contaminated with Listeria monocytogenes. |
| Apr 13, 2018 | ROSE ACRE FARM | Food | Shell eggs have the potential to be contaminated with Salmonella Braenderup. |
| Apr 12, 2018 | AMA Wholesale | Drugs | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. The presence of tadalafil makes… |
| Apr 11, 2018 | Seabear Company | Food | Products recalled due to water phase salt deviations and mislabeling of storage instructions on finished products labels |
| Apr 11, 2018 | Seabear Company | Food | Products recalled due to water phase salt deviations and mislabeling of storage instructions on finished products labels |
| Apr 9, 2018 | Whole Foods Market | Food | The cheese has the potential to be contaminated with Listeria monocytogenes. |
| Apr 6, 2018 | Bob's Red Mill Natural Foods, Inc. | Food | Amaranth Flour is recalled due to potential for contamination with Salmonella. |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 6, 2018 | TRIANGLE PHARMANATURALS LLC | Food | All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with… |
| Apr 5, 2018 | Abbott | Devices | Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will experience a persistent low… |
| Apr 5, 2018 | Cut Fruit Express, Inc. | Food | Bruschetta Dip and Bruschetta Mix are recalled because they contain undeclared Milk & Soy. |
| Apr 5, 2018 | Seacrest Foods International, Inc. | Food | The cheese has the potential to be contaminated with Listeria monocytogenes. |
| Apr 4, 2018 | Global Commodities Corp. | Food | Salmonella found in one lot of grated coconut though sampling and testing by the California Department of Public Health |
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