FDA Warning Letters, 483s and Recalls: October 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 |
|---|---|---|---|
| Oct 31, 2022 | Abraxis Bioscience LLC | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Oct 28, 2022 | Amazon.Com, Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| Oct 28, 2022 | Latin Foods Market | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| Oct 28, 2022 | Walmart Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| Oct 27, 2022 | Happy Sprout Inc. | Division of Human and Animal Food Operations East II | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions |
| Oct 27, 2022 | Titans Global Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Oct 26, 2022 | Lucero Produce II Corp. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Oct 24, 2022 | Cryos International USA LLC | Division of Biological Products Operations I | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Oct 24, 2022 | Lakpura LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Oct 21, 2022 | Nephron Pharmaceuticals Corporation Dba Nephron Sterile Compounding Center, LLC | Office of Pharmaceutical Quality Operations, Division II | Compounding Pharmacy/Adulterated Drug Products |
| Oct 19, 2022 | Pepe’S Foods Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Oct 19, 2022 | RiteAid Corporation | Center for Drug Evaluation and Research | CDER | Failure to Comply with Drug Listing Requirements/Misbranded |
| Oct 18, 2022 | Facema, LLC. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Oct 18, 2022 | HolleHippos LLC | Division of Southeast Imports | Foreign Supplier Verification Program (FSVP) |
| Oct 18, 2022 | McConnell Labs Inc. | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated |
| Oct 17, 2022 | Unit Dose Services, LLC | Center for Drug Evaluation and Research | CDER | Failure to Comply with Drug Listing Requirements |
| Oct 17, 2022 | Zuland Distributor Corp | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Oct 14, 2022 | Fuentes Farms LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Oct 11, 2022 | Nephron SC Inc. | Office of Pharmaceutical Quality Operations, Division II | CGMP/Finished Pharmaceuticals/Adulterated |
| Oct 7, 2022 | Leimax, Corp. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Oct 6, 2022 | Empowered Diagnostics LLC | Center for Devices and Radiological Health | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
| Oct 5, 2022 | Beijing Xinggu Lvsan Technology Co., Ltd. Formerly Known As Beijing Lvsan Technology Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug/Misbranded |
| Oct 5, 2022 | Eksa Mills S.A. De C.V. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Oct 5, 2022 | Sovereign Pharmaceuticals, LLC | Office of Pharmaceutical Quality Operations, Division II | CGMP/Finished Pharmaceuticals/Adulterated |
| Oct 4, 2022 | Rich River Produce, LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Oct 3, 2022 | Legacy Pharmaceutical Packaging LLC | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/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 |
|---|---|---|---|
| Oct 28, 2022 | Broncolin, S.A. De C.V. | Drugs | Mexico |
| Oct 28, 2022 | Greenfield Produce Imports | Food/Cosmetics | United States |
| Oct 28, 2022 | SOHGAVE LLC | Food/Cosmetics | United States |
| Oct 27, 2022 | Green City Distribution | Food/Cosmetics | United States |
| Oct 27, 2022 | Maria W. Greenwald, M.D. | Drugs | United States |
| Oct 26, 2022 | Randy J. Epstein, M.D. | Drugs | United States |
| Oct 26, 2022 | Synovo Production, Inc. | Devices | United States |
| Oct 25, 2022 | Eurovet Animal Health B.V. | Veterinary | Netherlands |
| Oct 24, 2022 | Victory Trading Company Inc. | Food/Cosmetics | United States |
| Oct 21, 2022 | ALK-Abello, Inc. | Drugs | United States |
| Oct 21, 2022 | Ernest Jackson & Co., Ltd. | Drugs | United Kingdom |
| Oct 21, 2022 | Madhu Instruments Private Limited | Drugs | India |
| Oct 21, 2022 | Mariscos Bahia, Inc. | Food/Cosmetics | United States |
| Oct 21, 2022 | New Look Cosmetics, Inc. | Drugs | United States |
| Oct 20, 2022 | Richard Wolf GmbH | Devices | Germany |
| Oct 19, 2022 | VAHDAM TEAS PVT LT | Food/Cosmetics | India |
| Oct 18, 2022 | Gasco Industrial Corp. | Drugs | United States |
| Oct 18, 2022 | Recipharm Monts | Drugs | France |
| Oct 14, 2022 | DSAART LLC | Devices | United States |
| Oct 14, 2022 | Hologic, Inc. | Devices | United States |
| Oct 14, 2022 | QuVa Pharma, Inc. | Drugs | United States |
| Oct 14, 2022 | Zermat Internacional, S.A. De C.V. | Drugs | Mexico |
| Oct 13, 2022 | BERLIN HEART GMBH | Devices | Germany |
| Oct 13, 2022 | Karl Storz SE & Co. KG | Devices | Germany |
| Oct 13, 2022 | Natural Hope Herbals, LLC | Food/Cosmetics | United States |
| Oct 13, 2022 | Vital Care Compounder, Inc | Drugs | United States |
| Oct 12, 2022 | Jeffrey W. Taub, M.D. | Drugs | United States |
| Oct 11, 2022 | CK Warmy LLC. | Devices | United States |
| Oct 11, 2022 | Primal Pet Foods Inc. | Veterinary | United States |
| Oct 7, 2022 | Sure-Biochem Laboratories, LLC | Drugs | United States |
| Oct 6, 2022 | Old Europe Cheese, Inc. | Food/Cosmetics | United States |
| Oct 4, 2022 | Adamson Analytical Laboratories, Inc. | Drugs | United States |
| Oct 3, 2022 | American Laboratories Pharma, 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 | 53 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 22 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 17 |
| 21 CFR 1.506(a)(1) | Unapproved supplier procedures - importer established | 15 |
| 21 CFR 1.506(b) | Supplier verification - follow written procedures | 13 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 13 |
| 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures | 13 |
| 21 CFR 117.35(c) | Pest control | 12 |
| 21 CFR 123.11(b) | Sanitation monitoring documentation | 12 |
| FDCA 501(a)(2)(A) | Vermin, adjacent area | 12 |
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 |
|---|---|---|---|
| Oct 28, 2022 | Kalera Public Limited Company | Food | Potential contamination with Salmonella |
| Oct 28, 2022 | Kalera Public Limited Company | Food | Potential contamination with Salmonella |
| Oct 28, 2022 | Kalera Public Limited Company | Food | Potential contamination with Salmonella |
| Oct 27, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the… |
| Oct 27, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the… |
| Oct 27, 2022 | DAISO CALIFORNIA WAREHOUSE | Food | Tiramisu Twist Cookies were found to have tree nuts not declared on the label |
| Oct 27, 2022 | Whole Foods Market Brand 365, Llc | Food | Undeclared wheat |
| Oct 24, 2022 | Whele LLC DBA Perch | Devices | The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation. |
| Oct 24, 2022 | Whele LLC DBA Perch | Devices | The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation. |
| Oct 24, 2022 | Whele LLC DBA Perch | Devices | The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation. |
| Oct 24, 2022 | Zingerman's Creamery, LLC | Food | undeclared egg |
| Oct 24, 2022 | Zingerman's Creamery, LLC | Food | undeclared egg |
| Oct 21, 2022 | Fayeon Distributors Inc. | Food | Product may contain undeclared milk |
| Oct 20, 2022 | Mariscos Bahia Inc | Food | Possible contamination with salmonella |
| Oct 20, 2022 | Mariscos Bahia Inc | Food | Possible contamination with salmonella |
| Oct 20, 2022 | Mariscos Bahia Inc | Food | Possible contamination with salmonella |
| Oct 20, 2022 | Mariscos Bahia Inc | Food | Possible contamination with salmonella |
| Oct 20, 2022 | Mariscos Bahia Inc | Food | Possible contamination with salmonella |
| Oct 20, 2022 | Mariscos Bahia Inc | Food | Possible contamination with salmonella |
| Oct 20, 2022 | Mariscos Bahia Inc | Food | Possible contamination with salmonella |
| Oct 20, 2022 | Remel Inc | Devices | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false… |
| Oct 20, 2022 | Remel Inc | Devices | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false… |
| Oct 20, 2022 | Remel Inc | Devices | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false… |
| Oct 20, 2022 | Remel Inc | Devices | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false… |
| Oct 20, 2022 | Remel Inc | Devices | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false… |
| Oct 20, 2022 | Remel Inc | Devices | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false… |
| Oct 20, 2022 | Remel Inc | Devices | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false… |
| Oct 20, 2022 | Remel Inc | Devices | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false… |
| Oct 20, 2022 | Remel Inc | Devices | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false… |
| Oct 20, 2022 | Seed Ranch Flavor Co | Food | Three sauces contain undeclared soy. |
| Oct 20, 2022 | Seed Ranch Flavor Co | Food | Three sauces contain undeclared soy. |
| Oct 20, 2022 | Seed Ranch Flavor Co | Food | Three sauces contain undeclared soy. |
| Oct 20, 2022 | Sodexo, DBA Nourish | Food | Undeclared peanut allergen |
| Oct 19, 2022 | Sotto I Trulli | Food | Undeclared allergen: Walnuts |
| Oct 17, 2022 | Albertsons Companies LLC | Food | Store printed label on products does not include Tree Nuts (Cashews) in the ingredient statement and the contains statement. |
| Oct 17, 2022 | Albertsons Companies LLC | Food | Store printed label on products does not include Tree Nuts (Cashews) in the ingredient statement and the contains statement. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | ARROW INTERNATIONAL Inc. | Devices | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Oct 17, 2022 | Insulet Corporation | Devices | The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which… |
| Oct 14, 2022 | DA CHENG VEGETARIAN FOOD INC. | Food | Vegan Golden nuggets were sampled by the FDA and found to contain egg that is not declared on the label. |
| Oct 14, 2022 | DA CHENG VEGETARIAN FOOD INC. | Food | Vegan Drumsticks were sampled by the FDA and found to contain egg that is not declared on the label. |
| Oct 14, 2022 | DA CHENG VEGETARIAN FOOD INC. | Food | Vegan Golden Nuggets were sampled by the FDA and found to contain egg that is not declared on the label. |
| Oct 13, 2022 | Hammond's Candies Since 1920 II, LLC | Food | Peanut Butter Chocolate Chip Cookies mispacked in Salted Caramel Cookies Box creating undeclared peanut allergen. |
| Oct 10, 2022 | Caire, Inc. | Devices | An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the… |
| Oct 10, 2022 | Caire, Inc. | Devices | An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the… |
| Oct 10, 2022 | Caire, Inc. | Devices | An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the… |
| Oct 10, 2022 | Caire, Inc. | Devices | An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the… |
| Oct 7, 2022 | Viatris Inc | Drugs | Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe. |
| Oct 6, 2022 | Bakkavor USA, Inc | Food | Bakkavor USA has initiated a recall of H-E-B Meal Simple Tomato Basil Soup, 32 oz. Plastic containers, 6 containers per case because of… |
| Oct 6, 2022 | Cuisine Innovations Unlimited, LLC | Food | Possible presence of Shiga toxin-producing E. coli. |
| Oct 6, 2022 | Cuisine Innovations Unlimited, LLC | Food | Possible presence of Shiga toxin-producing E. coli. |
| Oct 5, 2022 | Cut Fruit Express, Inc. | Food | Brie cheese has the potential to be contaminated with Listeria monocytogenes. |
| Oct 4, 2022 | Exela Pharma Sciences LLC | Drugs | Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration |
| Oct 4, 2022 | Exela Pharma Sciences LLC | Drugs | Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration |
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