FDA Warning Letters, 483s and Recalls: November 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 |
|---|---|---|---|
| Nov 30, 2022 | CHS Inc./CHS River Plains | Division of Human and Animal Food Operations West I | CGMP/Medicated Feeds/Adulterated |
| Nov 30, 2022 | Kari Gran Inc. | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated |
| Nov 29, 2022 | Gobwa Exotic Imports Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Nov 28, 2022 | AG Hair Limited | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Nov 28, 2022 | Bainbridge Beverage West, LLC | Division of Human and Animal Food Operations West V | Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Nov 28, 2022 | Mike Millenkamp Dairy Cattle | Division of Human and Animal Food Operations West II | New Animal Drug/Adulterated |
| Nov 22, 2022 | Aspire Pharmaceuticals, Inc. | Division of Human and Animal Food Operations East II | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |
| Nov 22, 2022 | Cecilia Alvarez | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Nov 22, 2022 | Florida Gold Foods LLC | Division of Human and Animal Food Operations East IV | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Nov 22, 2022 | Glenmark Pharmaceuticals Limited | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Nov 22, 2022 | MD Pharmaceutical Supply, LLC | Division of Pharmaceutical Quality Operations I | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Nov 21, 2022 | Euphoria Fancy Food Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Nov 21, 2022 | Nature’S Way Farms, LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Nov 18, 2022 | "David M. Lubeck, M.D./Arbor Centers For EyeCare | Center for Drug Evaluation and Research | CDER | Clinical Investigator (Sponsor) |
| Nov 18, 2022 | North American Custom Laboratories, LLC Dba FarmaKeio Superior Custom Compounding | Division of Pharmaceutical Quality Operations II | Compounding Pharmacy/Adulterated Drug Products |
| Nov 18, 2022 | RoyalVibe Health Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded |
| Nov 17, 2022 | Mark S. Denker, M.D., PA Dba Palm Beach Fertility Center | Division of Biological Products Operations I | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Nov 16, 2022 | 11-11-11 Brands | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| Nov 16, 2022 | CBD American Shaman, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| Nov 16, 2022 | Evimeria El Aztecano, Inc. | Division of Human and Animal Food Operations West V | Dietary Supplement/Misbranded |
| Nov 16, 2022 | Infusionz, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| Nov 16, 2022 | Naturally Infused LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| Nov 16, 2022 | Newhere Inc Dba CBDFX | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| Nov 16, 2022 | Wintech Medipro LLC | Division of Medical Device and Radiological Health Operations West | CGMP/QSR/Medical Devices/PMA/Adulterated |
| Nov 14, 2022 | Anabolic Laboratories Inc | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| Nov 14, 2022 | BergaMet North America LLC | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| Nov 14, 2022 | Calroy Health Sciences, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| Nov 14, 2022 | Chambers' Apothecary | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| Nov 14, 2022 | Essential Elements | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| Nov 14, 2022 | Goodimmuno.Com | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| Nov 14, 2022 | Healthy Trends Worldwide, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| Nov 14, 2022 | Iwi | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| Nov 14, 2022 | Yourtramadol.Com | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| Nov 9, 2022 | Invitrx Therapeutics, Inc. | Division of Biological Products Operations II | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Nov 9, 2022 | J R Imports LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Nov 8, 2022 | Abbott Point Of Care Canada Limited | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Nov 8, 2022 | Dollar Tree, Inc. | Office of Human and Animal Food Operations – West Division 3 | Interstate Commerce/Food/Adulterated |
| Nov 7, 2022 | Conners Clinic | Center for Food Safety and Applied Nutrition | New Drug/Misbranded |
| Nov 7, 2022 | HST Produce, Inc. | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Nov 7, 2022 | K2 Trading Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Nov 7, 2022 | Land View, Inc. | Division of Human and Animal Food Operations West VI | CGMP/Medicated Feeds/Adulterated |
| Nov 7, 2022 | Maliba African Market Corp. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Nov 7, 2022 | Manzela USA, LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Nov 7, 2022 | Todos Medical Ltd Aka Todos Medical USA Inc | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Nov 4, 2022 | Winfrey's Olde English Fudge, Inc. | Division of Human and Animal Food Operations East I | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions |
| Nov 3, 2022 | The Anthos Group, Inc. | Center for Drug Evaluation and Research | CDER | Refusal to Provide Access to and Copying of Records |
| Nov 2, 2022 | Aizu Olympus Co., Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded |
| Nov 2, 2022 | Gold Coast Distributors Inc. Dba Shah Distributors | Division of Human and Animal Food Operations West V | CGMP/Warehouse/Insanitary Conditions/Adulterated |
| Nov 2, 2022 | Omega & Delta Co., Inc. | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated |
| Nov 1, 2022 | Alternative Health Distribution LLC D/B/A CannaAid | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19) |
| Nov 1, 2022 | Del Valle Import Corp. | Division of Northeast 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 |
|---|---|---|---|
| Nov 30, 2022 | HotHead Vapor, LLC | Tobacco | United States |
| Nov 30, 2022 | Pharmacy Innovations | Drugs | United States |
| Nov 30, 2022 | U-Can Food Trading, Inc. | Food/Cosmetics | United States |
| Nov 29, 2022 | Sin City Vapor LLC | Tobacco | United States |
| Nov 29, 2022 | Valley View Milling LLC | Veterinary | United States |
| Nov 25, 2022 | AmulFed Dairy (Previously Known As Mother Dairy) - A Unit Of GCMMF Ltd | Food/Cosmetics | India |
| Nov 25, 2022 | Juicer Connections, Inc. | Food/Cosmetics | United States |
| Nov 23, 2022 | Lupin Limited | Drugs | India |
| Nov 22, 2022 | Purechempros LLC | Drugs | United States |
| Nov 22, 2022 | TRANSU INVESTMENT GROUP, LLC | Food/Cosmetics | United States |
| Nov 21, 2022 | Biloxi Freezing & Processing, Inc. | Food/Cosmetics | United States |
| Nov 21, 2022 | Centaur Pharmaceuticals Private Ltd. | Drugs | India |
| Nov 18, 2022 | Tropical Bakery Wholesale Corp | Food/Cosmetics | United States |
| Nov 17, 2022 | Atlantic Bakery Ltd. | Food/Cosmetics | United States |
| Nov 17, 2022 | El Rey USA Meats & Seafood Inc | Food/Cosmetics | United States |
| Nov 17, 2022 | Milky Way International Trading Corporation | Food/Cosmetics | United States |
| Nov 17, 2022 | Omega Packaging Corp | Drugs | United States |
| Nov 17, 2022 | RAYSEARCH LABORATORIES AB | Devices | Sweden |
| Nov 17, 2022 | Sabor Vapors LLC | Tobacco | United States |
| Nov 17, 2022 | USV Private Limited | Drugs | India |
| Nov 16, 2022 | Eden's Answers Inc | Food/Cosmetics | United States |
| Nov 15, 2022 | Yummy Fresh Never Frozen, LLC | Food/Cosmetics | United States |
| Nov 14, 2022 | Medifactia AB | Devices | Sweden |
| Nov 14, 2022 | Santa Cruz Produce, Inc. | Food/Cosmetics | United States |
| Nov 10, 2022 | Midwest Sterilization Corporation | Devices | United States |
| Nov 10, 2022 | OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant | Devices | Japan |
| Nov 10, 2022 | Pharmaplast S.A.E. | Drugs | Egypt |
| Nov 10, 2022 | RemedyRePack Inc. | Drugs | United States |
| Nov 8, 2022 | Royal Chemical Company | Drugs | United States |
| Nov 8, 2022 | Steiner Biotechnology LLC | Devices | United States |
| Nov 8, 2022 | Western New York Energy, LLC | Drugs | United States |
| Nov 7, 2022 | Pharmedica USA, LLC | Drugs | United States |
| Nov 4, 2022 | Barkey GmbH & Co. KG | Devices | Germany |
| Nov 4, 2022 | Fischer ANalysen Instrumente GmbH | Devices | Germany |
| Nov 4, 2022 | Yusef Manufacturing Laboratories, LLC | Drugs | United States |
| Nov 3, 2022 | Drivergent, Inc. | Drugs | United States |
| Nov 3, 2022 | Dynasthetics LLC | Devices | United States |
| Nov 1, 2022 | LA ALDEA DISTRIBUTORS INC | Food/Cosmetics | 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 | 54 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 24 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 22 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 19 |
| 21 CFR 123.11(b) | Sanitation monitoring | 18 |
| 21 CFR 123.6(b) | No HACCP plan | 15 |
| 21 CFR 123.6(c)(1) | Food safety hazards | 15 |
| 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures | 15 |
| 21 CFR 117.35(c) | Pest control | 14 |
| 21 CFR 211.22(d) | Procedures not in writing, fully followed | 14 |
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 |
|---|---|---|---|
| Nov 29, 2022 | Accord Healthcare, Inc. | Drugs | Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial |
| Nov 28, 2022 | Exela Pharma Sciences LLC | Drugs | Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration. |
| Nov 28, 2022 | Exela Pharma Sciences LLC | Drugs | Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration. |
| Nov 28, 2022 | Universal Meditech Inc. | Devices | Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization. |
| Nov 24, 2022 | Emergent Protective Products USA Inc | Devices | Complaints of leaking packets were received. |
| Nov 17, 2022 | GREEN DAY PRODUCE | Food | Product found to be contaminated with Listeria monocytogenes |
| Nov 10, 2022 | Boston Baking Inc. | Food | undeclared pecans (treenuts) |
| Nov 7, 2022 | Comercializadora Pepsico Mexico, | Food | Potential to contain Salmonella |
| Nov 7, 2022 | Seven Seas International USA LLC | Food | Possible Listeria monocytogenes contamination in smoked salmon |
| Nov 5, 2022 | Adam's Polishes LLC | Drugs | Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain… |
Check one company
See one company's full record with the free FDA compliance check, or search warning letters and Form 483 citations by name.