FDA Warning Letters, 483s and Recalls: April 2023
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 |
|---|---|---|---|
| Apr 28, 2023 | Gary’S Cheesecakes & Fine Desserts | Division of Human and Animal Food Operations East V | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Apr 28, 2023 | Pharmedica USA, LLC | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated |
| Apr 27, 2023 | EarthLab, Inc., Dba Wise Woman Herbals | Division of Human and Animal Food Operations West VI | Unapproved New Drugs/Misbranded |
| Apr 27, 2023 | Tager Online, Inc. DBA Volt Candy; Volt Candy Wholesale Club | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| Apr 25, 2023 | Krishiv Foods, LLC | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) |
| Apr 24, 2023 | Nose Slap LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| Apr 20, 2023 | Accra-Pac, Inc. Dba Voyant Beauty | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated |
| Apr 19, 2023 | Medolife Rx D/B/A MedoLife Corp., AELIA, Inc. And Quanta Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| Apr 19, 2023 | Sorcerz.Com | Center for Drug Evaluation and Research | CDER | Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet |
| Apr 17, 2023 | Victory Trading Company Inc. | Division of Human and Animal Food Operations East I | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Apr 14, 2023 | Milky Way International Trading Corporation | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Apr 13, 2023 | Pharmaplast S.A.E. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Apr 11, 2023 | Jerez Produce, Inc. | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) |
| Apr 11, 2023 | Juicer Connections, Inc. | Division of Human and Animal Food Operations West V | Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Apr 10, 2023 | Champaklal Maganlal Homeo Pharmacy Private Limited | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Apr 7, 2023 | STPCA Inc. Dba Sun Ten Laboratories | Division of Human and Animal Food Operations West V | Unapproved New Drugs/Misbranded |
| Apr 6, 2023 | SCS Direct, Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | Dietary Supplement/Adulterated |
| Apr 6, 2023 | Zermat International S.A. De C.V. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Apr 5, 2023 | Chemical Services Group, Inc./Royal Chemical Company | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated |
| Apr 4, 2023 | ByPro Nutrition LLC | Division of Human and Animal Food Operations West II | Unapproved New Drugs/Misbranded |
| Apr 4, 2023 | Sea-Long Medical Systems, LLC | Division of Medical Device and Radiological Health Operations West | CGMP/QSR/Medical Devices/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 |
|---|---|---|---|
| Apr 28, 2023 | CHESHNI FOODS, LLC | Food/Cosmetics | United States |
| Apr 28, 2023 | Raptim Research Pvt. Ltd. | Drugs | India |
| Apr 27, 2023 | BioLyte Laboratories, LLC | Drugs | United States |
| Apr 27, 2023 | Spectrum Medical Ltd. | Devices | United Kingdom |
| Apr 26, 2023 | Amy Lightner MD | Biologics | United States |
| Apr 26, 2023 | MKK Imports | Food/Cosmetics | United States |
| Apr 26, 2023 | Perrigo Wisconsin, LLC | Food/Cosmetics | United States |
| Apr 25, 2023 | A-1 Engineering | Devices | United States |
| Apr 24, 2023 | Gondi S.A. | Food/Cosmetics | Ecuador |
| Apr 22, 2023 | AGRICOLA SKY RANCH, S. DE R.L. DE C.V. | Food/Cosmetics | Mexico |
| Apr 21, 2023 | ABC Compounding Co., Inc. | Drugs | United States |
| Apr 21, 2023 | Hacienda Mexican Foods | Food/Cosmetics | United States |
| Apr 21, 2023 | Sciegen Pharmaceuticals Inc | Drugs | United States |
| Apr 21, 2023 | Wa Heng Dou-Fu And Soy Sauce Corporation | Food/Cosmetics | United States |
| Apr 20, 2023 | Biosensors Interventional Technologies Pte Ltd | Devices | Singapore |
| Apr 17, 2023 | Tailift Co., Ltd. | Devices | Taiwan |
| Apr 14, 2023 | Fruits Tress, Inc. | Food/Cosmetics | United States |
| Apr 14, 2023 | Natural Relief Inc. | Food/Cosmetics | United States |
| Apr 14, 2023 | Sanitor Corporation | Drugs | United States |
| Apr 14, 2023 | The Bonami Baking Company, Inc. | Food/Cosmetics | United States |
| Apr 13, 2023 | Abiomed, Inc. | Devices | United States |
| Apr 13, 2023 | BroadMaster Biotech Corp. | Devices | Taiwan |
| Apr 13, 2023 | TOMI ENTERPRISES LLC | Food/Cosmetics | United States |
| Apr 12, 2023 | COLONIAL DAMES CO LTD | Drugs | United States |
| Apr 11, 2023 | Uon USA Inc | Food/Cosmetics | United States |
| Apr 10, 2023 | Mena Produce, LLC | Food/Cosmetics | United States |
| Apr 6, 2023 | Oceanitan, Inc. | Food/Cosmetics | United States |
| Apr 5, 2023 | Apollo Care, LLC | Drugs | United States |
| Apr 4, 2023 | Similasan AG | Drugs | Switzerland |
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 | 78 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 19 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 18 |
| 21 CFR 1.505(a)(2) | Evaluation - performance, risk | 16 |
| 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition | 15 |
| 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard | 15 |
| 21 CFR 117.135(a)(1) | Sanitation preventive controls - Implement | 14 |
| 21 CFR 117.40 | Equipment and utensils - Design and maintenance | 13 |
| 21 CFR 123.6(b) | No HACCP plan | 12 |
| 21 CFR 1.506(d)(1)(i) | Verification activity frequency | 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 |
|---|---|---|---|
| Apr 28, 2023 | General Mills, Inc | Food | Flour has the potential to be contaminated with Salmonella. |
| Apr 28, 2023 | General Mills, Inc | Food | Flour has the potential to be contaminated with Salmonella. |
| Apr 26, 2023 | Gadget Island, Inc | Drugs | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found… |
| Apr 26, 2023 | Gadget Island, Inc | Drugs | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found… |
| Apr 26, 2023 | Gadget Island, Inc | Drugs | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found… |
| Apr 20, 2023 | Euro-Pharma | Food | undeclared allergen (milk) |
| Apr 20, 2023 | Lipari Foods Operating Company, LLC. | Food | Product tested positive for Salmonella |
| Apr 20, 2023 | Novis PR, LLC Dba Kramer Novis | Drugs | Product mix-up: incorrect product was found inside the G-Supress DX product carton. |
| Apr 17, 2023 | Abiomed, Inc. | Devices | The Impella 5.5 pump experienced a heightened complaint rate for purge leaks. |
| Apr 17, 2023 | Draeger Medical, Inc. | Devices | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of… |
| Apr 17, 2023 | Draeger Medical, Inc. | Devices | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of… |
| Apr 17, 2023 | Draeger Medical, Inc. | Devices | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of… |
| Apr 17, 2023 | Draeger Medical, Inc. | Devices | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of… |
| Apr 17, 2023 | Draeger Medical, Inc. | Devices | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of… |
| Apr 17, 2023 | Draeger Medical, Inc. | Devices | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of… |
| Apr 17, 2023 | Draeger Medical, Inc. | Devices | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of… |
| Apr 17, 2023 | Draeger Medical, Inc. | Devices | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of… |
| Apr 17, 2023 | Draeger Medical, Inc. | Devices | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of… |
| Apr 17, 2023 | Draeger Medical, Inc. | Devices | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of… |
| Apr 17, 2023 | Draeger Medical, Inc. | Devices | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of… |
| Apr 17, 2023 | Draeger Medical, Inc. | Devices | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of… |
| Apr 17, 2023 | Draeger Medical, Inc. | Devices | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of… |
| Apr 17, 2023 | Draeger Medical, Inc. | Devices | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of… |
| Apr 17, 2023 | Draeger Medical, Inc. | Devices | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of… |
| Apr 17, 2023 | Draeger Medical, Inc. | Devices | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of… |
| Apr 17, 2023 | Draeger Medical, Inc. | Devices | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of… |
| Apr 17, 2023 | Draeger Medical, Inc. | Devices | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of… |
| Apr 17, 2023 | Draeger Medical, Inc. | Devices | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of… |
| Apr 17, 2023 | Draeger Medical, Inc. | Devices | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of… |
| Apr 17, 2023 | Draeger Medical, Inc. | Devices | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of… |
| Apr 17, 2023 | Draeger Medical, Inc. | Devices | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of… |
| Apr 14, 2023 | Washington Crab & Seafood Company, Inc. | Food | Undeclared egg and soy. |
| Apr 14, 2023 | Washington Crab & Seafood Company, Inc. | Food | Undeclared egg, wheat and soy. |
| Apr 13, 2023 | Dakota Style, Inc | Food | May contain undeclared milk |
| Apr 13, 2023 | Dakota Style, Inc | Food | May contain undeclared milk |
| Apr 13, 2023 | Dakota Style, Inc | Food | May contain undeclared milk |
| Apr 13, 2023 | Dakota Style, Inc | Food | May contain undeclared milk |
| Apr 13, 2023 | SUMMIT NATURALS INC | Food | The firm was notified that a consumer had an allergic reaction to their product. The product did not list egg on the label. |
| Apr 13, 2023 | SUMMIT NATURALS INC | Food | The firm was notified that a consumer had an allergic reaction to their product. The product did not list egg on the label. |
| Apr 13, 2023 | Willamette Hazelnut, Inc. | Food | Undeclared Almonds and Cashews |
| Apr 13, 2023 | Willamette Hazelnut, Inc. | Food | Undeclared Almonds and Cashews |
| Apr 11, 2023 | Medtronic Navigation, Inc. | Devices | During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy… |
| Apr 11, 2023 | Medtronic Navigation, Inc. | Devices | In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled… |
| Apr 10, 2023 | DIBE LLC | Food | Undeclared allergens: Soy and Walnuts |
| Apr 10, 2023 | DIBE LLC | Food | Undeclared allergens: Soy and Wheat |
| Apr 10, 2023 | DIBE LLC | Food | Undeclared allergens: Soy and Wheat |
| Apr 7, 2023 | Cook Incorporated | Devices | There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other… |
| Apr 7, 2023 | Cook Incorporated | Devices | There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other… |
| Apr 7, 2023 | Fresh Express Incorpated | Food | The firm was notified by one of their customers that their product test positive for Listeria monocytogenes. |
| Apr 7, 2023 | Fresh Express Incorpated | Food | The firm was notified by one of their customers that their product test positive for Listeria monocytogenes. |
| Apr 7, 2023 | Fresh Express Incorpated | Food | The firm was notified by one of their customers that their product test positive for Listeria monocytogenes. |
| Apr 7, 2023 | Mondi Lamex Serbia | Food | Potential contamination with Hepatitis A |
| Apr 5, 2023 | Caledonia Facility Of Revolution Farms LLC | Food | Listeria monocytogenes |
| Apr 5, 2023 | Caledonia Facility Of Revolution Farms LLC | Food | Listeria monocytogenes |
| Apr 5, 2023 | Caledonia Facility Of Revolution Farms LLC | Food | Listeria monocytogenes |
| Apr 5, 2023 | Caledonia Facility Of Revolution Farms LLC | Food | Listeria monocytogenes |
| Apr 5, 2023 | Caledonia Facility Of Revolution Farms LLC | Food | Listeria monocytogenes |
| Apr 5, 2023 | Caledonia Facility Of Revolution Farms LLC | Food | Listeria monocytogenes |
| Apr 5, 2023 | Caledonia Facility Of Revolution Farms LLC | Food | Listeria monocytogenes |
| Apr 5, 2023 | Meijer Inc | Food | Listeria monocytogenes |
| Apr 5, 2023 | Meijer Inc | Food | Listeria monocytogenes |
| Apr 5, 2023 | Meijer Inc | Food | Listeria monocytogenes |
| Apr 5, 2023 | Meijer Inc | Food | Listeria monocytogenes |
| Apr 5, 2023 | Meijer Inc | Food | Listeria monocytogenes |
| Apr 5, 2023 | Meijer Inc | Food | Listeria monocytogenes |
| Apr 5, 2023 | Meijer Inc | Food | Listeria monocytogenes |
| Apr 5, 2023 | Meijer Inc | Food | Listeria monocytogenes |
| Apr 5, 2023 | Meijer Inc | Food | Listeria monocytogenes |
| Apr 5, 2023 | Meijer Inc | Food | Listeria monocytogenes |
| Apr 3, 2023 | JX Restaurants, Inc. | Food | Undeclared allergen (egg) |
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