FDA Warning Letters, 483s and Recalls: March 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 |
|---|---|---|---|
| Mar 31, 2023 | Belmar Pharma Solutions, Drug Depot, LLC., Dba APS Pharmacy | Division of Pharmaceutical Quality Operations II | Compounding Pharmacy/Adulterated Drug Products |
| Mar 30, 2023 | ALI Pharmaceutical Manufacturing, LLC | Division of Pharmaceutical Quality Operations III | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Mar 29, 2023 | Five Star Trading IL, Inc. | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) |
| Mar 28, 2023 | Pop Daddy Popcorn, LLC | Division of Human and Animal Food Operations East VI | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Mar 24, 2023 | Liberty Fruit Co. Inc. DBA Carol’S Cuts | Division of Human and Animal Food Operations West II | Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Mar 24, 2023 | Sure-Biochem Laboratories, LLC | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated |
| Mar 23, 2023 | Synovo Production, Inc. | Division of Medical Device and Radiological Health Operations West | CGMP/QSR/Medical Devices/Adulterated |
| Mar 22, 2023 | Tyrone L. McCall, M.D./Cornea Associates Of Texas | Center for Drug Evaluation and Research | CDER | Clinical Investigator (Sponsor) |
| Mar 20, 2023 | Omega Packaging Corp | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated |
| Mar 17, 2023 | Brand Packaging Group, Inc. | Division of Human and Animal Food Operations East I | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |
| Mar 17, 2023 | Old Europe Cheese, Inc. | Division of Human and Animal Food Operations East VI | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Mar 16, 2023 | Biloxi Freezing & Processing, Inc. | Division of Human and Animal Food Operations East V | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Mar 16, 2023 | Sol-Ti Inc. | Division of Human and Animal Food Operations West V | Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Mar 16, 2023 | Www.Ivermectin4Covid.Com | Center for Drug Evaluation and Research | CDER | Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet |
| Mar 15, 2023 | Olympus Medical Systems Corp. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Mar 14, 2023 | Procter & Gamble Manufactura S. De R.L. De C.V. | Center for Drug Evaluation and Research | CDER | Failure to Register and List |
| Mar 14, 2023 | Robert J. Hayashi, M.D./Washington University School Of Medicine, Department Of Pediatrics | Center for Drug Evaluation and Research | CDER | Bioresearch Monitoring Program/IRB |
| Mar 13, 2023 | J&H Imports Services Corp | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Mar 13, 2023 | NuGeneration Technologies LLC | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated |
| Mar 10, 2023 | Cosmetic Science Laboratories LLC | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated |
| Mar 8, 2023 | Santa Cruz Produce, Inc. | Division of Southeast Imports | Foreign Supplier Verification Program (FSVP) |
| Mar 8, 2023 | Spartan Enterprises Inc. Dba Watershed Wellness Center | Division of Human and Animal Food Operations East VI | Unapproved New Drugs/Misbranded |
| Mar 8, 2023 | Wise Spice Catering Company | Division of Human and Animal Food Operations East IV | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Mar 7, 2023 | Herbal Vitality, Inc. | Division of Human and Animal Food Operations West IV | Unapproved New Drugs/Misbranded |
| Mar 3, 2023 | Maggie Jeffries, M.D. / Avanti Anesthesiology, LLC | Center for Drug Evaluation and Research | CDER | Clinical Investigator |
| Mar 2, 2023 | ElectRx And Health Solutions, LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| Mar 1, 2023 | Formology Lab Inc. | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated |
| Mar 1, 2023 | Promar Seafood S. De R.L. | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/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 |
|---|---|---|---|
| Mar 31, 2023 | ABS Distribution Inc. | Tobacco | United States |
| Mar 31, 2023 | Xylo Chem Industries | Drugs | India |
| Mar 30, 2023 | Central Admixture Pharmacy Services, Inc. | Drugs | United States |
| Mar 30, 2023 | Philosys Co. Ltd | Devices | Korea (the Republic of) |
| Mar 30, 2023 | Vidasoy | Food/Cosmetics | United States |
| Mar 29, 2023 | ECO FOOD DISTRIBUTION | Food/Cosmetics | United States |
| Mar 27, 2023 | BLUE STONE IMPORT USA INC | Food/Cosmetics | United States |
| Mar 24, 2023 | Asaderos & Quesos El Campeon, LLC | Food/Cosmetics | United States |
| Mar 24, 2023 | Delsam Pharma LLC | Drugs | United States |
| Mar 24, 2023 | Handock Cosmetics Co., Ltd. | Drugs | Korea (the Republic of) |
| Mar 24, 2023 | Hi-Tech Pharmaceuticals Inc. | Food/Cosmetics | United States |
| Mar 24, 2023 | Spectrum Laboratory Products, Inc. | Drugs | United States |
| Mar 23, 2023 | GTG WELLNESS CO LTD | Devices | Korea (the Republic of) |
| Mar 23, 2023 | Premier Food Supplies LLC | Food/Cosmetics | United States |
| Mar 23, 2023 | Tesla Biohealing, Inc. | Devices | United States |
| Mar 22, 2023 | Lacteos Mi Chalatenango, Inc | Food/Cosmetics | United States |
| Mar 22, 2023 | Safersonic Medizinprodukte Handelsges MBH | Devices | Austria |
| Mar 21, 2023 | EzriCare, LLC. | Drugs | United States |
| Mar 17, 2023 | Knobbe Cattle Company Inc. | Veterinary | United States |
| Mar 17, 2023 | Living Tree Community Foods | Food/Cosmetics | United States |
| Mar 17, 2023 | Richard W. Foltin, Ph.D. | Drugs | United States |
| Mar 16, 2023 | ADM Animal Nutrition | Veterinary | United States |
| Mar 16, 2023 | CANADIAN GENERAL FILTERS LIMITED | Devices | Canada |
| Mar 16, 2023 | Kentucky Farms Kitchen Inc. | Food/Cosmetics | United States |
| Mar 16, 2023 | Moorish Science Temple The Divine And National Movement Of North America, Inc; #13 The Moorish American National Republic | Food/Cosmetics | United States |
| Mar 16, 2023 | Safecor Health, LLC | Drugs | United States |
| Mar 16, 2023 | T-MED SRL | Devices | Italy |
| Mar 15, 2023 | COSMOBEAUTI LABORATORIES & MANUFACTURING, INC. | Drugs | United States |
| Mar 13, 2023 | Canyon Farms, Inc. | Food/Cosmetics | United States |
| Mar 13, 2023 | Desserts By Helen, Inc. | Food/Cosmetics | United States |
| Mar 10, 2023 | Ceph Lifesciences Private Limited | Drugs | India |
| Mar 10, 2023 | Ming Fai Industrial (Shenzhen) Co LTD | Devices | China |
| Mar 9, 2023 | Creation Technologies LTD | Devices | Canada |
| Mar 9, 2023 | FVD Produce, LLC | Food/Cosmetics | United States |
| Mar 8, 2023 | Maos Produce | Food/Cosmetics | United States |
| Mar 7, 2023 | C K Frozen Fish And Food Inc. | Food/Cosmetics | United States |
| Mar 7, 2023 | Hot Grabba LLC | Tobacco | United States |
| Mar 3, 2023 | Facema, LLC. | Food/Cosmetics | United States |
| Mar 3, 2023 | Frenchman Valley Farmers Cooperative, Inc. | Veterinary | United States |
| Mar 2, 2023 | Cetylite Industries, Inc. | Drugs | United States |
| Mar 2, 2023 | Global Pharma Healthcare Private Limited | Drugs | India |
| Mar 2, 2023 | MiMedx Group, Inc. | Biologics | United States |
| Mar 2, 2023 | MiMedx Group, Inc. | Biologics | United States |
| Mar 1, 2023 | Chean Industries Dominicana S.R.L. | Food/Cosmetics | Dominican Republic (the) |
| Mar 1, 2023 | Dairy Feeds Inc | Veterinary | 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 | 78 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 33 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 25 |
| 21 CFR 117.40 | Equipment and utensils - Design and maintenance | 23 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 23 |
| 21 CFR 117.10 | Personnel | 20 |
| 21 CFR 123.11(b) | Sanitation monitoring documentation | 20 |
| 21 CFR 1.506(d)(1)(i) | Verification activity frequency | 20 |
| 21 CFR 211.192 | Written record of investigation incomplete | 18 |
| 21 CFR 117.35(c) | Pest control | 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 |
|---|---|---|---|
| Mar 31, 2023 | SD Biosensor, Inc. | Devices | The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor… |
| Mar 30, 2023 | Lamb Weston Sales | Food | Undeclared Wheat in foodservice item Hashbrown patties. |
| Mar 28, 2023 | Percussionaire Corporation | Devices | Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy. |
| Mar 28, 2023 | Winland Foods, Inc. | Food | The firm was notified by a customer that the outer case label indicates the product contains eggs. However, the primary product label does… |
| Mar 27, 2023 | Jarman's Midwest Cleaning Systems, Inc. | Drugs | Chemical Contamination: FDA testing found Presence of methanol |
| Mar 27, 2023 | Jarman's Midwest Cleaning Systems, Inc. | Drugs | Chemical Contamination: FDA testing found Presence of methanol |
| Mar 27, 2023 | North American Food Dist. Co., Inc. | Food | Products contain soy that is not declared on the label. |
| Mar 27, 2023 | North American Food Dist. Co., Inc. | Food | Products contain soy that is not declared on the label. |
| Mar 24, 2023 | Cordis US Corp | Devices | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to… |
| Mar 24, 2023 | Cordis US Corp | Devices | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to… |
| Mar 24, 2023 | Cordis US Corp | Devices | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to… |
| Mar 24, 2023 | Cordis US Corp | Devices | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to… |
| Mar 24, 2023 | Cordis US Corp | Devices | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to… |
| Mar 24, 2023 | Cordis US Corp | Devices | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to… |
| Mar 24, 2023 | Cordis US Corp | Devices | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to… |
| Mar 24, 2023 | Cordis US Corp | Devices | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to… |
| Mar 24, 2023 | Cordis US Corp | Devices | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to… |
| Mar 24, 2023 | Cordis US Corp | Devices | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to… |
| Mar 24, 2023 | Cordis US Corp | Devices | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to… |
| Mar 24, 2023 | Cordis US Corp | Devices | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to… |
| Mar 24, 2023 | Cordis US Corp | Devices | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to… |
| Mar 24, 2023 | Cordis US Corp | Devices | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to… |
| Mar 24, 2023 | Covidien | Devices | A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure… |
| Mar 23, 2023 | Gilster-Mary Lee Corp. | Food | Undeclared milk |
| Mar 23, 2023 | Kar Nut Products Company | Food | Product is labeled "Gluten Free" but may contain undeclared wheat. |
| Mar 23, 2023 | NSI Group LLC | Food | Product testing was found positive for Salmonella. |
| Mar 22, 2023 | ICU Medical Inc | Devices | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery… |
| Mar 22, 2023 | ICU Medical Inc | Devices | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery… |
| Mar 22, 2023 | ICU Medical Inc | Devices | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery… |
| Mar 22, 2023 | ICU Medical Inc | Devices | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery… |
| Mar 19, 2023 | JABSONS FOODS PRIVATE LIMITED (Formerly Known As Jabsons Cottonseed Ind.Pvt.Ltd.) | Food | Undeclared Milk |
| Mar 19, 2023 | JABSONS FOODS PRIVATE LIMITED (Formerly Known As Jabsons Cottonseed Ind.Pvt.Ltd.) | Food | Undeclared Milk |
| Mar 19, 2023 | JABSONS FOODS PRIVATE LIMITED (Formerly Known As Jabsons Cottonseed Ind.Pvt.Ltd.) | Food | Undeclared Milk |
| Mar 19, 2023 | JABSONS FOODS PRIVATE LIMITED (Formerly Known As Jabsons Cottonseed Ind.Pvt.Ltd.) | Food | Undeclared Milk |
| Mar 19, 2023 | JABSONS FOODS PRIVATE LIMITED (Formerly Known As Jabsons Cottonseed Ind.Pvt.Ltd.) | Food | Undeclared Milk |
| Mar 17, 2023 | Mutual Trading Company Inc. | Food | Undeclared allergen; soy. |
| Mar 17, 2023 | Mutual Trading Company Inc. | Food | Undeclared allergen; soy. |
| Mar 17, 2023 | Mutual Trading Company Inc. | Food | Undeclared allergen; soy. |
| Mar 17, 2023 | PATAGONIA FOOD LLC | Food | Possible Hepatitis A in blackberries |
| Mar 17, 2023 | Perrigo Nutritionals | Food | Infant Formula has the potential to be contaminated with Cronobacter spp. |
| Mar 16, 2023 | SALENTO ORGANICS LLC | Food | Undeclared Milk. |
| Mar 16, 2023 | SALENTO ORGANICS LLC | Food | Undeclared Milk. |
| Mar 16, 2023 | SALENTO ORGANICS LLC | Food | Undeclared Milk. |
| Mar 16, 2023 | SALENTO ORGANICS LLC | Food | Undeclared Milk. |
| Mar 16, 2023 | SALENTO ORGANICS LLC | Food | Undeclared Milk. |
| Mar 16, 2023 | SALENTO ORGANICS LLC | Food | Undeclared Milk. |
| Mar 16, 2023 | Scenic Fruit Company, LLC | Food | Potential to be contaminated with hepatitis A. |
| Mar 16, 2023 | Scenic Fruit Company, LLC | Food | Potential to be contaminated with hepatitis A. |
| Mar 16, 2023 | Scenic Fruit Company, LLC | Food | Potential to be contaminated with hepatitis A. |
| Mar 15, 2023 | California Splendor, Inc. | Food | Product may be contaminated with Hepatitis A |
| Mar 15, 2023 | California Splendor, Inc. | Food | Product may be contaminated with Hepatitis A |
| Mar 15, 2023 | California Splendor, Inc. | Food | Product may be contaminated with Hepatitis A |
| Mar 14, 2023 | BC Gourmet USA, Inc. | Food | Product contains undeclared pine nuts. |
| Mar 13, 2023 | Camber Pharmaceuticals Inc. | Drugs | Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of… |
| Mar 13, 2023 | Seven Seas International USA LLC | Food | Potential contamination with Listeria monocytogenes. |
| Mar 10, 2023 | Fresenius Kabi USA, LLC | Devices | Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or… |
| Mar 7, 2023 | Clio LLC | Food | Possible contamination with Listeria monocytogenes |
| Mar 3, 2023 | DAISO CALIFORNIA WAREHOUSE | Food | no fish (Bonito, Sardines, Tuna) listed on ingredients or contains statement |
| Mar 3, 2023 | DAISO CALIFORNIA WAREHOUSE | Food | Fish (Sardines, Bonito, Tuna) not listed either in ingredients list or in the contains statement |
| Mar 1, 2023 | Philips Respironics, Inc. | Devices | The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen… |
| Mar 1, 2023 | Philips Respironics, Inc. | Devices | The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen… |
| Mar 1, 2023 | Philips Respironics, Inc. | Devices | The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen… |
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