FDA Warning Letters, 483s and Recalls: September 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 |
|---|---|---|---|
| Sep 30, 2022 | El Gordo Spices, LLC | Division of Human and Animal Food Operations West III | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Sep 30, 2022 | MicroVention Costa Rica S.R.L. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Sep 28, 2022 | Bespoke Apothecary LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Sep 27, 2022 | Lupin Limited | Center for Drug Evaluation and Research | CDER | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Sep 27, 2022 | Sterling Pharmaceutical Services, LLC | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 26, 2022 | Advanced Cosmetic Research Laboratories Inc. | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
| Sep 26, 2022 | Vero USA Corporation | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Sep 23, 2022 | Muscle Sports Products, LLC | Office of Human and Animal Food Operations East – Division 1 | Unapproved New Drugs/Misbranded |
| Sep 23, 2022 | Saffron USA LLC | Division of Human and Animal Food Operations East IV | Unapproved New Drugs/Misbranded |
| Sep 21, 2022 | ARYZ Trading LLC | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) |
| Sep 21, 2022 | Forcemech International LLC | Office of Medical Device and Radiological Health Division 3 | CGMP/QSR/Medical Devices/Adulterated |
| Sep 20, 2022 | Eco Lips, Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 20, 2022 | Effingham Equity | Division of Human and Animal Food Operations East VI | CGMP/Medicated Feeds/Adulterated |
| Sep 20, 2022 | Mena Produce LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Sep 20, 2022 | South Pork Ranch Equipment LLC | Center for Veterinary Medicine | Unapproved New Animal Drug/Adulterated |
| Sep 19, 2022 | La Serranita Import And Export LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Sep 15, 2022 | Med Pen Concepts, LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Sep 12, 2022 | C. Liberatore LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Sep 9, 2022 | System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 7, 2022 | The Bonami Baking Company, Inc. | Division of Human and Animal Food Operations West V | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions |
| Sep 6, 2022 | American Cleaning Solutions | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 6, 2022 | Third Synthesis Inc., Dba Chicago Sweet Connections, Inc. | Division of Human and Animal Food Operations East VI | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions |
| Sep 2, 2022 | Banks Square Market Corp. Dba The Produce Connection | Office of Human and Animal Food Operations - East Division 1 | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes |
| Sep 2, 2022 | El Salvador Products Inc | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Sep 2, 2022 | Sanitizer Supply LLC | Office of Pharmaceutical Quality Operations, Division II | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 1, 2022 | Shuzy Rock Inc. | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 1, 2022 | Virgin Scent Inc. Dba Artnaturals | Division of Pharmaceutical Quality Operations IV | 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 |
|---|---|---|---|
| Sep 30, 2022 | Akan Biosciences Inc | Biologics | United States |
| Sep 30, 2022 | Arrow Reliance Inc | Veterinary | United States |
| Sep 30, 2022 | Syenz Laboratory, LLC | Drugs | United States |
| Sep 29, 2022 | Angela M. Stupi, M.D. | Drugs | United States |
| Sep 29, 2022 | MBB Production Mexico S. De R.L. De C.V. | Drugs | Mexico |
| Sep 29, 2022 | Mondimex, LLC | Food/Cosmetics | United States |
| Sep 28, 2022 | Delimports LLC | Food/Cosmetics | United States |
| Sep 28, 2022 | Fong Kee Tofu Co., Inc. | Food/Cosmetics | United States |
| Sep 28, 2022 | Torrent Pharmaceuticals Limited | Drugs | India |
| Sep 27, 2022 | Milbar Laboratories, Inc. | Drugs | United States |
| Sep 26, 2022 | Cornerstone Veterinary Services LLC | Veterinary | United States |
| Sep 24, 2022 | Fenwal International, Inc. | Biologics | United States |
| Sep 23, 2022 | RC Outsourcing, LLC | Drugs | United States |
| Sep 23, 2022 | Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. Ve Tic. A.S. | Devices | Turkey |
| Sep 22, 2022 | Ada Teff | Food/Cosmetics | United States |
| Sep 22, 2022 | Corporate Essentials LLC | Food/Cosmetics | United States |
| Sep 22, 2022 | Defender SD Manufacturing LLC | Drugs | United States |
| Sep 22, 2022 | NuGeneration Technologies, LLC | Drugs | United States |
| Sep 22, 2022 | Wu's Tech (Vietnam) Co., Ltd. | Devices | Vietnam |
| Sep 21, 2022 | JUS International Inc | Food/Cosmetics | United States |
| Sep 20, 2022 | Cosmetic Science Laboratories, LLC | Drugs | United States |
| Sep 20, 2022 | TAIWAN BIOTECH CO., LTD. | Drugs | Taiwan |
| Sep 19, 2022 | Tyrone McCall, M.D. | Drugs | United States |
| Sep 16, 2022 | Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil | Drugs | Turkey |
| Sep 16, 2022 | Emmons Livestock | Veterinary | United States |
| Sep 15, 2022 | RDM Express Inc. | Food/Cosmetics | United States |
| Sep 15, 2022 | Scully's Wonderful Stuff Inc | Drugs | United States |
| Sep 14, 2022 | Schreiber Foods, Inc. | Food/Cosmetics | United States |
| Sep 12, 2022 | Select Produce LLC | Food/Cosmetics | United States |
| Sep 9, 2022 | Curexa - East, LLC | Drugs | United States |
| Sep 9, 2022 | Formology Lab Inc. | Drugs | United States |
| Sep 9, 2022 | Laboratorio Genove SA | Drugs | Spain |
| Sep 9, 2022 | Medina Baking And Powder Products, Inc. | Food/Cosmetics | United States |
| Sep 9, 2022 | Olympus Medical Systems Corporation | Devices | Japan |
| Sep 9, 2022 | Ruth Special Food Store LLC | Food/Cosmetics | United States |
| Sep 8, 2022 | Sea-Long Medical Systems, LLC | Devices | United States |
| Sep 7, 2022 | NARA CO.,LTD. | Food/Cosmetics | Japan |
| Sep 2, 2022 | Accra-Pac, Inc. | Food/Cosmetics | United States |
| Sep 2, 2022 | Anatox Incorporated | Food/Cosmetics | United States |
| Sep 2, 2022 | Marcus Research Laboratory, Inc. | Veterinary | United States |
| Sep 2, 2022 | Massco Dental | Drugs | United States |
| Sep 2, 2022 | Pop Daddy Popcorn, LLC | Food/Cosmetics | United States |
| Sep 2, 2022 | VistaPharm LLC | Drugs | United States |
| Sep 1, 2022 | Big Olaf Creamery LLC | Food/Cosmetics | United States |
| Sep 1, 2022 | Opto-Pharm Pte Ltd. | Drugs | Singapore |
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 | 98 |
| 21 CFR 1.505(a)(2) | Evaluation - performance, risk | 24 |
| 21 CFR 211.22(d) | Procedures not in writing, fully followed | 22 |
| 21 CFR 117.135(a)(1) | Sanitation preventive controls - Implement | 20 |
| 21 CFR 117.35(c) | Pest control | 20 |
| 21 CFR 1.506(a)(1) | Unapproved supplier procedures - importer established | 20 |
| 21 CFR 117.10 | Personnel | 19 |
| 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls | 18 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 18 |
| 21 CFR 1.506(b) | Supplier verification - establish written procedures | 17 |
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 |
|---|---|---|---|
| Sep 30, 2022 | Baxter Healthcare Corporation | Devices | Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry… |
| Sep 30, 2022 | Baxter Healthcare Corporation | Devices | Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry… |
| Sep 30, 2022 | Baxter Healthcare Corporation | Devices | Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry… |
| Sep 30, 2022 | Baxter Healthcare Corporation | Devices | Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry… |
| Sep 30, 2022 | Baxter Healthcare Corporation | Devices | Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry… |
| Sep 30, 2022 | Swiss American Inc | Food | Potential contamination with Listeria monocytogenes |
| Sep 30, 2022 | Whole Foods Market Brand 365, Llc | Food | Undeclared egg sourced from egg lysozyme |
| Sep 29, 2022 | Golden State Medical Supply Inc. | Drugs | Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets |
| Sep 28, 2022 | Diana's Bananas, Inc. | Food | undeclared peanut |
| Sep 28, 2022 | Old Europe Cheese, Inc. | Food | potential contamination with Listeria monocytogenes |
| Sep 28, 2022 | Old Europe Cheese, Inc. | Food | potential contamination with Listeria monocytogenes |
| Sep 28, 2022 | Old Europe Cheese, Inc. | Food | potential contamination with Listeria monocytogenes |
| Sep 28, 2022 | Old Europe Cheese, Inc. | Food | potential contamination with Listeria monocytogenes |
| Sep 28, 2022 | Old Europe Cheese, Inc. | Food | potential contamination with Listeria monocytogenes |
| Sep 28, 2022 | Old Europe Cheese, Inc. | Food | potential contamination with Listeria monocytogenes |
| Sep 28, 2022 | Old Europe Cheese, Inc. | Food | potential contamination with Listeria monocytogenes |
| Sep 28, 2022 | Old Europe Cheese, Inc. | Food | potential contamination with Listeria monocytogenes |
| Sep 28, 2022 | Old Europe Cheese, Inc. | Food | potential contamination with Listeria monocytogenes |
| Sep 28, 2022 | Old Europe Cheese, Inc. | Food | potential contamination with Listeria monocytogenes |
| Sep 27, 2022 | Momyer Distributors Inc | Food | Undeclared Milk |
| Sep 23, 2022 | Arcade Industries, Inc. | Food | Product contains undeclared egg. |
| Sep 19, 2022 | World Variety Produce Inc Dba Melissa's | Food | Dutch Red Potatoes were packed with a Dijon Mustard Sauce packet that did not declare the allergen of egg. |
| Sep 16, 2022 | Mothers Touch Formula | Food | The product does not conform to the FDA's infant formula standards for sale in the United States. |
| Sep 14, 2022 | Salon Technologies International Inc | Drugs | Chemical Contamination: product found to contain benzene |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 12, 2022 | Renaissance Food Group | Food | Firm received positive test results for L. monocytogenes in a finished product. All products manufactured with the same components are… |
| Sep 8, 2022 | Fresenius Kabi USA, LLC | Devices | The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing… |
| Sep 8, 2022 | Muktanand Foods Inc | Food | Undeclared sulfites |
| Sep 6, 2022 | Philips Respironics, Inc. | Devices | No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the… |
| Sep 6, 2022 | Philips Respironics, Inc. | Devices | No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the… |
| Sep 6, 2022 | Philips Respironics, Inc. | Devices | No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the… |
| Sep 6, 2022 | Philips Respironics, Inc. | Devices | No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the… |
| Sep 6, 2022 | Philips Respironics, Inc. | Devices | No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the… |
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