FDA Warning Letters, 483s and Recalls: June 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 |
|---|---|---|---|
| Jun 30, 2022 | Bi-Coastal Pharma International | Office of Pharmaceutical Quality Operations Division I | CGMP/Finished Pharmaceuticals/Adulterated |
| Jun 30, 2022 | Bioiberica, SAU | Center for Drug Evaluation and Research | CDER | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Jun 30, 2022 | Herbsens Botanicals | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug |
| Jun 30, 2022 | Imprimis Rx LLC | Division of Pharmaceutical Quality Operations IV | False & Misleading Claims/Misbranded |
| Jun 30, 2022 | Klarity Kratom | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug |
| Jun 30, 2022 | Kratom Exchange | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug |
| Jun 30, 2022 | MONQ, LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug |
| Jun 30, 2022 | Omni Consumer Products LLC D/B/A YoKratom | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug |
| Jun 30, 2022 | W.H.P.M, Inc. | Office of Medical Device and Radiological Health Division 3 | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
| Jun 27, 2022 | DDI Multinacional S.A. De C.V. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Jun 27, 2022 | Noticias Mexico Hoy Grupo Multimedia, S.A. De C.V. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Jun 27, 2022 | Regino Produce LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Jun 24, 2022 | Brad Grate Dairy Farm | Office of Human and Animal Food Operations East Division 6 | New Animal Drug/Adulterated |
| Jun 24, 2022 | Flores Produce, Inc. | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Jun 24, 2022 | North30 LLC | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Jun 24, 2022 | Zhang Medical P.C. Dba New Hope Fertility Center | Office of Biological Products Operations – Division 1 | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Jun 22, 2022 | Industrias Cklass S. De R.L. De C.V. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Jun 22, 2022 | Mirfeel Korea Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
| Jun 17, 2022 | Conservas Ortiz S.A. | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Jun 17, 2022 | Nicamex Seafood | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Jun 16, 2022 | InfuTronix LLC | Office of Medical Devices and Radiological Health Operations Div. 1 East | CGMP/QSR/Medical Devices/Adulterated |
| Jun 14, 2022 | Fagron Group B.V. | Division of Pharmaceutical Quality Operations III | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Jun 14, 2022 | H2 Beverages, Inc. | Division of Human and Animal Food Operations West III | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Jun 13, 2022 | Glicerinas Industriales, S.A. De C.V. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Drug Products/Refusal/Limited Inspection |
| Jun 10, 2022 | Monarch PCM, LLC | Office of Pharmaceutical Quality Operations, Division II | CGMP/Finished Pharmaceuticals/Adulterated |
| Jun 10, 2022 | Young Living Essential Oils Corporate | Office of Human and Animal Food Operations – West Division 4 | New Drug/Misbranded |
| Jun 9, 2022 | Winfull Corporation | Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Jun 8, 2022 | New Sun Inc. | Office of Human and Animal Foods- East Division 3 | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| Jun 7, 2022 | Hybrid Pharma, LLC | Office of Pharmaceutical Quality Operations, Division II | Compounding Pharmacy/Adulterated Drug Products |
| Jun 6, 2022 | SDJJ Distributors | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Jun 1, 2022 | Jam Jam Services, Inc. | Division of Southeast Imports | Foreign Supplier Verification Program (FSVP) |
| Jun 1, 2022 | S&S Quality Wholesale Inc. | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Jun 1, 2022 | Supreme Fruit Produce, Inc. | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
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 |
|---|---|---|---|
| Jun 30, 2022 | Fresenius Kabi USA LLC | Drugs | United States |
| Jun 29, 2022 | Bainbridge Beverage West, LLC | Food/Cosmetics | United States |
| Jun 28, 2022 | Chaur Fong Inc. | Food/Cosmetics | United States |
| Jun 27, 2022 | A&Z Pharmaceutical Inc | Food/Cosmetics | United States |
| Jun 27, 2022 | Carie Boyd Pharmaceuticals LLC | Drugs | United States |
| Jun 27, 2022 | Land View Inc | Veterinary | United States |
| Jun 24, 2022 | AG Hair Ltd. | Drugs | Canada |
| Jun 24, 2022 | Manzela USA, LLC | Food/Cosmetics | United States |
| Jun 24, 2022 | Maquet Cardiopulmonary GmbH | Devices | Germany |
| Jun 23, 2022 | Midwestern Pet Foods, Inc. | Veterinary | United States |
| Jun 22, 2022 | AMO And Wing Inc. | Food/Cosmetics | United States |
| Jun 22, 2022 | Billet Box Vapor | Tobacco | United States |
| Jun 22, 2022 | Dell Vapers | Tobacco | United States |
| Jun 22, 2022 | Glenmark Pharmaceuticals Limited | Drugs | India |
| Jun 22, 2022 | Jones Affiliated Inc. | Food/Cosmetics | United States |
| Jun 21, 2022 | Mena Produce, LLC | Food/Cosmetics | United States |
| Jun 17, 2022 | American Cruise Lines, Inc. | Food/Cosmetics | United States |
| Jun 17, 2022 | Captain Alex Seafood, Ltd. | Food/Cosmetics | United States |
| Jun 17, 2022 | Heliora Laboratories Pty Ltd. | Drugs | Australia |
| Jun 17, 2022 | Martinez Mexican Produce Llc | Food/Cosmetics | United States |
| Jun 16, 2022 | HolleHippos LLC | Food/Cosmetics | United States |
| Jun 14, 2022 | Stephen G. Kaler, M.D. | Drugs | United States |
| Jun 13, 2022 | Dercher Enterprises, Inc. | Drugs | United States |
| Jun 13, 2022 | Quality Supplement Manufacturing, Inc. | Food/Cosmetics | United States |
| Jun 10, 2022 | Cosmaceutical Research Lab Inc. | Drugs | Canada |
| Jun 10, 2022 | FARMAKEIO OUTSOURCING LLC | Drugs | United States |
| Jun 10, 2022 | Irvington Seafood, Inc. | Food/Cosmetics | United States |
| Jun 10, 2022 | Schreiber Foods, Inc. | Food/Cosmetics | United States |
| Jun 9, 2022 | Biomerics ATL Costa Rica | Devices | Costa Rica |
| Jun 9, 2022 | GMS International Foods Inc. | Food/Cosmetics | United States |
| Jun 9, 2022 | J.M. Smucker LLC | Food/Cosmetics | United States |
| Jun 9, 2022 | NNS Organics Limited | Food/Cosmetics | Canada |
| Jun 8, 2022 | El Salvador Products Inc. | Food/Cosmetics | United States |
| Jun 8, 2022 | Midwestern Pet Foods, Inc. | Veterinary | United States |
| Jun 8, 2022 | Panacea Biotec Pharma Limited | Drugs | India |
| Jun 8, 2022 | VERO USA CORPORATION | Food/Cosmetics | United States |
| Jun 7, 2022 | BLUE STONE IMPORT USA INC | Food/Cosmetics | United States |
| Jun 7, 2022 | Fresno Valley Importing LLC | Food/Cosmetics | United States |
| Jun 3, 2022 | Emily K. Curran, M.D. | Drugs | United States |
| Jun 3, 2022 | Pharmalab 1982 Inc. | Food/Cosmetics | Canada |
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 | 31 |
| 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls | 17 |
| 21 CFR 117.135(a)(1) | Sanitation preventive controls - Implement | 16 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 16 |
| 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard | 15 |
| 21 CFR 117.35(c) | Pest control | 15 |
| 21 CFR 117.10 | Personnel | 14 |
| 21 CFR 1.505(a)(2) | Evaluation - performance, risk | 13 |
| 21 CFR 1.506(d)(1)(i) | Verification activity frequency | 13 |
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 |
|---|---|---|---|
| Jun 28, 2022 | Heartware, Inc. | Devices | Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery… |
| Jun 27, 2022 | Fuchs North America, Inc. | Food | The product may be potentially positive for Salmonella due to one of the sub-ingredients (oregano) testing positive for Salmonella. |
| Jun 27, 2022 | Hamilton Medical AG | Devices | Ventilator status indicator board can become loose, which could lead to water ingress (disinfectants) that may lead to technical fault… |
| Jun 27, 2022 | Loud Muscle Science | Drugs | Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the… |
| Jun 27, 2022 | Loud Muscle Science | Drugs | Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the… |
| Jun 27, 2022 | Loud Muscle Science | Drugs | Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the… |
| Jun 27, 2022 | Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy | Drugs | Subpotent and Superpotent Drug |
| Jun 24, 2022 | OS Holding Inc | Food | Ground organic oregano is recalled due to presence of Salmonella leeuwarden. |
| Jun 23, 2022 | Pure Ground Ingredients | Food | Potential Salmonella contamination. |
| Jun 22, 2022 | Baxter Healthcare Corporation | Devices | There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software. |
| Jun 22, 2022 | Blount Fine Foods Corporation | Food | Contains undeclared wheat |
| Jun 22, 2022 | Integra LifeSciences Corp. | Devices | Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor… |
| Jun 22, 2022 | Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF) | Devices | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome… |
| Jun 22, 2022 | Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF) | Devices | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome… |
| Jun 22, 2022 | Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF) | Devices | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome… |
| Jun 22, 2022 | Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF) | Devices | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome… |
| Jun 22, 2022 | Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF) | Devices | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome… |
| Jun 22, 2022 | Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF) | Devices | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome… |
| Jun 22, 2022 | Select Bakery Inc. | Food | Possible undeclared Walnuts. Undeclared Yellow #5, Yellow #6 and Red #40. |
| Jun 22, 2022 | Select Bakery Inc. | Food | Possible undeclared Walnuts. Undeclared Red #40. |
| Jun 21, 2022 | Tarts A La Carte, LLC Dba Blazo Pie Shoppe LLC | Food | Blazos Pie Shoppe Peanut Butter Cream Pie, Chocolate Peanut Butter Cream Pie and Peanut Butter Cream Cup products possibly contaminated… |
| Jun 21, 2022 | Tarts A La Carte, LLC Dba Blazo Pie Shoppe LLC | Food | Blazos Pie Shoppe Peanut Butter Cream Pie, Chocolate Peanut Butter Cream Pie and Peanut Butter Cream Cup products possibly contaminated… |
| Jun 20, 2022 | Bard Access Systems, Inc. | Devices | BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may… |
| Jun 17, 2022 | Bryant Ranch Prepack, Inc. | Drugs | Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release… |
| Jun 17, 2022 | Bryant Ranch Prepack, Inc. | Drugs | Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release… |
| Jun 16, 2022 | J & M Foods, Inc. | Food | Undeclared egg and soy lecithin |
| Jun 15, 2022 | North American Diagnostics | Devices | Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without… |
| Jun 13, 2022 | Vi-Jon, LLC | Drugs | Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of Gluconacetobacter Liquefaciens |
| Jun 10, 2022 | Latin Foods Market | Drugs | Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and dexamethasone. |
| Jun 9, 2022 | Chaur Fong Inc. Dba 888 Food Company | Food | Undeclared egg |
| Jun 9, 2022 | Chaur Fong Inc. Dba 888 Food Company | Food | Undeclared egg |
| Jun 9, 2022 | Chaur Fong Inc. Dba 888 Food Company | Food | Undeclared egg |
| Jun 9, 2022 | Chaur Fong Inc. Dba 888 Food Company | Food | Undeclared egg |
| Jun 9, 2022 | Chaur Fong Inc. Dba 888 Food Company | Food | Undeclared egg |
| Jun 9, 2022 | Chaur Fong Inc. Dba 888 Food Company | Food | Undeclared egg |
| Jun 9, 2022 | Chaur Fong Inc. Dba 888 Food Company | Food | Undeclared egg |
| Jun 9, 2022 | Green Pharmaceuticals, Inc. | Drugs | Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as… |
| Jun 8, 2022 | BUILT BRANDS LLC | Food | Banana Cream Pie Puff Protein Bars have the potential to be contaminated with Escherichia coli. |
| Jun 8, 2022 | Buzzagogo, LLC | Drugs | Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain elevated levels of yeast and mold as well… |
| Jun 8, 2022 | Covidien Llc | Devices | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub… |
| Jun 8, 2022 | Covidien Llc | Devices | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub… |
| Jun 8, 2022 | Covidien Llc | Devices | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub… |
| Jun 8, 2022 | Covidien Llc | Devices | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub… |
| Jun 8, 2022 | Covidien Llc | Devices | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub… |
| Jun 8, 2022 | Covidien Llc | Devices | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub… |
| Jun 8, 2022 | Covidien Llc | Devices | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub… |
| Jun 8, 2022 | Covidien Llc | Devices | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub… |
| Jun 8, 2022 | Covidien Llc | Devices | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub… |
| Jun 8, 2022 | Wilbur's Of Maine Chocolate Confections | Food | Product contains undeclared almonds. |
| Jun 7, 2022 | Gourmondo Cafes & Catering | Food | Asparagus and Feta Sandwich is recalled due to undeclared eggs (allergens) in the sub-ingredient for mayonnaise. |
| Jun 7, 2022 | JR Simplot Food Group | Food | Frozen french fries is being recalled due to undeclared wheat. |
| Jun 7, 2022 | Plastikon Healthcare LLC | Drugs | Microbial Contamination of Non-Sterile Products |
| Jun 7, 2022 | Plastikon Healthcare LLC | Drugs | Microbial Contamination of Non-Sterile Products. |
| Jun 7, 2022 | Plastikon Healthcare LLC | Drugs | Microbial Contamination of Non-Sterile Products. |
| Jun 7, 2022 | Plastikon Healthcare LLC | Drugs | Microbial Contamination of Non-Sterile Products. |
| Jun 7, 2022 | Royal Ice Cream Company | Food | Product is being recalled due to undeclared peanuts. |
| Jun 3, 2022 | Prairie City Bakery | Food | Salmonella. Product contains recalled Jif peanut butter as ingredient. |
| Jun 1, 2022 | GE Healthcare, LLC | Devices | There is a potential reversal of the O2 and air cylinder pressure transducer connections. |
| Jun 1, 2022 | Irvington Seafood, Inc. Dba ISF, Inc. | Food | possible contamination of Listeria monocytogenes |
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