FDA Warning Letters, 483s and Recalls: January 2022
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 |
|---|---|---|---|
| Jan 28, 2022 | Skin Sheek | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Jan 28, 2022 | Swan Brothers Dairy Inc | Office of Human and Animal Food Operations West Division 3 | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes |
| Jan 28, 2022 | TreeHouse Foods, Inc. | Division of Human and Animal Food Operations East II | Low Acid Canned Food Regulation/Adulterated |
| Jan 27, 2022 | 5,000 Years Foods, Inc. | Office of Human and Animal Food Operations, East Division VI | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Jan 26, 2022 | Innoveix Pharmaceuticals Inc | Office of Pharmaceutical Quality Operations, Division II | Compounding Pharmacy/Adulterated Drug Products |
| Jan 24, 2022 | Greenhead Lobster Products LLC | Office of Human and Animal Food Operations- East Division 1 | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Jan 19, 2022 | Glenn Burkett Naples Corporation | Office of Human and Animal Food Operations East Division IV | Unapproved New Drugs/Misbranded |
| Jan 18, 2022 | CES LLC | Center for Drug Evaluation and Research | CDER | Drug Product/Misbranded |
| Jan 14, 2022 | Picket Fence Creamery LLC | Division of Human and Animal Food Operations West II | Food Labeling/Misbranded |
| Jan 12, 2022 | Aurobindo Pharmaceutical Limited | Center for Drug Evaluation and Research | CDER | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Jan 12, 2022 | Kemal Balikcilik Ihracat | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated |
| Jan 11, 2022 | Saad Trading Inc. | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) |
| Jan 10, 2022 | Onofrio's Fresh Cut, Inc. | Office of Human and Animal Food Operations - East Division 1 | CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Jan 7, 2022 | Molino Enterprises One, Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Jan 7, 2022 | Professional Disposables International, Inc. | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated |
| Jan 7, 2022 | Wickimed Medical Equipment Manufacturing Co., Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Jan 6, 2022 | Concord Farms, Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Jan 6, 2022 | Cosmo Bio Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
| Jan 6, 2022 | Patidar Trade, Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Jan 6, 2022 | Unimicro Medical Systems-Shenzhen Co., Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Jan 5, 2022 | HK Produce Group Inc. DBA Y2S Trading Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Jan 4, 2022 | Bakery Project Inc. Dba Delano Bakery | Office of Human and Animal Food- West Division II | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Jan 3, 2022 | Amcyte Pharma, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19) |
| Jan 3, 2022 | Pure Ground Ingredients, Inc. | Division of Human and Animal Food Operations West V | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/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 |
|---|---|---|---|
| Jan 31, 2022 | Effingham Equity | Veterinary | United States |
| Jan 28, 2022 | TRANSU INVESTMENT GROUP, LLC | Food/Cosmetics | United States |
| Jan 27, 2022 | Atlantic Bakery Ltd. | Food/Cosmetics | United States |
| Jan 27, 2022 | Greenfield Produce Imports | Food/Cosmetics | United States |
| Jan 26, 2022 | Cali Rice Valley, Inc. | Food/Cosmetics | United States |
| Jan 25, 2022 | Still Water Dairy, LLC | Veterinary | United States |
| Jan 24, 2022 | Fres Co, LLC | Food/Cosmetics | United States |
| Jan 21, 2022 | Datascope Corp. | Devices | United States |
| Jan 21, 2022 | Jost Chemical Co. | Drugs | United States |
| Jan 21, 2022 | Morningstar Minerals LLC | Food/Cosmetics | United States |
| Jan 20, 2022 | American Chinese Medicine Association, Inc | Drugs | United States |
| Jan 19, 2022 | Russ Davis Wholesale Inc | Food/Cosmetics | United States |
| Jan 18, 2022 | ABJ Grocers LLC | Food/Cosmetics | United States |
| Jan 18, 2022 | CFP Acquisitions Inc. | Drugs | United States |
| Jan 18, 2022 | Everyday Group LLC | Food/Cosmetics | United States |
| Jan 18, 2022 | SDJJ DISTRIBUTORS INC | Food/Cosmetics | United States |
| Jan 15, 2022 | Cronus Pharma Specialities India Pvt Ltd | Veterinary | India |
| Jan 14, 2022 | Bi-Coastal Pharma International | Drugs | United States |
| Jan 13, 2022 | Ole Smoky Candy Kitchen Factory | Food/Cosmetics | United States |
| Jan 11, 2022 | Alymar LLC | Food/Cosmetics | United States |
| Jan 10, 2022 | Deggeh Foods Inc. | Food/Cosmetics | United States |
| Jan 7, 2022 | Agila Corporation | Veterinary | United States |
| Jan 7, 2022 | TRIPLE J FRESH LLC | Food/Cosmetics | United States |
| Jan 6, 2022 | Colorlab Cosmetics, Inc. | Drugs | United States |
| Jan 5, 2022 | GLOBAL IMPORTS INC | Food/Cosmetics | United States |
| Jan 5, 2022 | Madras Groceries | Food/Cosmetics | United States |
| Jan 5, 2022 | Yamaya USA Inc | Food/Cosmetics | United States |
| Jan 4, 2022 | Nutra Valley 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 | 42 |
| 21 CFR 1.506(b) | Supplier verification - establish written procedures | 11 |
| 21 CFR 1.506(d)(1)(i) | Verification activity frequency | 10 |
| 21 CFR 1.505(a)(2) | Evaluation - performance, risk | 8 |
| 21 CFR 1.506(a)(1) | Unapproved supplier procedures - follow, document use | 8 |
| 21 CFR 1.506(e)(1) | Verification activity before import, periodically | 8 |
| 21 CFR 1.504(a) | Hazard analysis written | 7 |
| 21 CFR 312.60 | Informed consent | 7 |
| 21 CFR 111.103 | Written procedures - quality control operations | 5 |
| 21 CFR 1.504(b)(1) | Hazard analysis biological, chemical, physical | 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 |
|---|---|---|---|
| Jan 31, 2022 | SD Biosensor, Inc. | Devices | Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution… |
| Jan 28, 2022 | CONAGRA BRANDS | Food | Undeclared eggs |
| Jan 28, 2022 | CONAGRA BRANDS | Food | Undeclared eggs |
| Jan 28, 2022 | Esupplementsales, LLC | Drugs | Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a… |
| Jan 27, 2022 | E25Bio, Inc. | Devices | The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. It was distributed without… |
| Jan 26, 2022 | AuroMedics Pharma LLC | Drugs | Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot |
| Jan 26, 2022 | Lyons Magnus, Inc | Food | Undeclared milk allergen due to mislabeling. |
| Jan 26, 2022 | Siren Snacks | Food | Undeclared cashews and almond butter allergens |
| Jan 25, 2022 | Blaine Labs Inc | Drugs | Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus. |
| Jan 24, 2022 | Respironics California, LLC | Devices | A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially… |
| Jan 24, 2022 | Respironics California, LLC | Devices | A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially… |
| Jan 19, 2022 | B.C.S. International Corporation | Food | Product contains undeclared sulfites. |
| Jan 13, 2022 | Lusys Laboratories, Inc. | Devices | COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or… |
| Jan 13, 2022 | Lusys Laboratories, Inc. | Devices | COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or… |
| Jan 13, 2022 | Lusys Laboratories, Inc. | Devices | COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or… |
| Jan 11, 2022 | TELEFLEX MEDICAL INC | Devices | The firm received reports indicating PTD tip separation during use. |
| Jan 11, 2022 | TELEFLEX MEDICAL INC | Devices | The firm received reports indicating PTD tip separation during use. |
| Jan 11, 2022 | TELEFLEX MEDICAL INC | Devices | The firm received reports indicating PTD tip separation during use. |
| Jan 11, 2022 | TELEFLEX MEDICAL INC | Devices | The firm received reports indicating PTD tip separation during use. |
| Jan 11, 2022 | TELEFLEX MEDICAL INC | Devices | The firm received reports indicating PTD tip separation during use. |
| Jan 11, 2022 | TELEFLEX MEDICAL INC | Devices | The firm received reports indicating PTD tip separation during use. |
| Jan 11, 2022 | TELEFLEX MEDICAL INC | Devices | The firm received reports indicating PTD tip separation during use. |
| Jan 10, 2022 | BASE 10 GENETICS INC | Devices | The product does not have 510(k) clearance. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 6, 2022 | Dole Fresh Vegetables Inc | Food | Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes. |
| Jan 5, 2022 | Mylan Pharmaceuticals Inc | Drugs | Labeling: Missing Label: label missing from some Semglee prefilled pens. |
| Jan 2, 2022 | Renaissance Food Group, LLC | Food | The firm discovered that some of their Chicken Salad Croissants contained Tuna Salad. Fish is not declared on the label. |
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