FDA Warning Letters, 483s and Recalls: April 2024
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 30, 2024 | Akan Biosciences, Inc. | Office of Biological Products Operations – Division I | CGMP/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Apr 30, 2024 | Global Cosmetics Company Limited | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Apr 30, 2024 | Grupo Quimico SRL | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Apr 30, 2024 | Ward Smelling Salts | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| Apr 30, 2024 | Washington Fertility Center | Division of Biological Products Operations I | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Apr 25, 2024 | Brewing Market Coffee | Division of Human and Animal Food Operations West IV | Acidified Foods/Emergency Permit Control/Adulterated |
| Apr 25, 2024 | California Bread Co. | Division of Human and Animal Food Operations West V | Food Labeling/Misbranded |
| Apr 24, 2024 | Cardinal Health | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded |
| Apr 24, 2024 | Sani-Care Salon Products, Inc. | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated |
| Apr 24, 2024 | Sheng Kee Of California, Inc Dba Sheng Kee Bakery | Center for Food Safety and Applied Nutrition (CFSAN) | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Apr 24, 2024 | Www.Dashpct.Com | Center for Drug Evaluation and Research | CDER | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet |
| Apr 23, 2024 | ISPE Produce, Inc. | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Apr 23, 2024 | Ng Zheng Inc. DBA Kwan Sang Noodle Company | Division of Human and Animal Food Operations West IV | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Apr 22, 2024 | Cookies-N-Milk, LLC | Division of Human and Animal Food West III Compliance Branch (HAFW3-CB) | CGMP/Packaging/Misbranded |
| Apr 22, 2024 | Rash Catering Services, LLC | Division of Southwest Imports | FSVP/Seafood HACCP |
| Apr 18, 2024 | APG SEVEN, INC | Division of Human and Animal Food Operations East IV | New Drug/Misbranded |
| Apr 18, 2024 | Dr Sankunni’S Ayurvedic Research Foundation Private Ltd. | Center for Drug Evaluation and Research | CDER | Failure to Register and List |
| Apr 18, 2024 | Zen Enterprises LLC | Center for Drug Evaluation and Research | CDER | Failure to Register and List |
| Apr 17, 2024 | Blue Caribbean Foods Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated |
| Apr 17, 2024 | G.N.R. Group Co., LTD. | Center for Food Safety and Applied Nutrition (CFSAN) | Juice/HACCP/Adulterated |
| Apr 17, 2024 | Ocean Group Inc. | Division of Human and Animal Food Operations West V | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Apr 17, 2024 | Pingdingshan Tianjing Plant Albumen Co., Ltd. | Center for Food Safety and Applied Nutrition (CFSAN) | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Apr 17, 2024 | Pinnacle Labs Of Tennessee, LLC Dba Pinnacle BioLabs | Center for Devices and Radiological Health | Medical Device/Misbranded |
| Apr 17, 2024 | Westwood Laboratories LLC | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated |
| Apr 15, 2024 | Cohere Beauty | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated |
| Apr 12, 2024 | Northern VA Compounders PLLC, Dba Akina Pharmacy | Office of Pharmaceutical Quality | Compounding Pharmacy/Adulterated Drug Products |
| Apr 11, 2024 | C&T Dream Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Apr 9, 2024 | Lipari Foods Operating Company, LLC | Division of Human and Animal Food Operations East VI | Food Labeling/Misbranded |
| Apr 8, 2024 | Natco Pharma Limited | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Apr 5, 2024 | Safari Stem Cell, LLC | Division of Biological Products Operations II | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
| Apr 4, 2024 | Hacienda Mexican Foods, LLC | Division of Human and Animal Food Operations East VI | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Apr 3, 2024 | Bioptimal International | "OHT2: Office of Cardiovascular Devices, Office of Product Evaluation and Quality" | CGMP/QSR/Medical Devices/Adulterated |
| Apr 3, 2024 | FirstCham Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
| Apr 3, 2024 | Jiangsu Meifan Biotechnology Co. Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Apr 2, 2024 | Stokes Healthcare Inc. Dba Epicur Pharma | Division of Pharmaceutical Quality Operations I | Compounding Pharmacy/Adulterated Drug Products |
| Apr 1, 2024 | New India Bazar, Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Apr 1, 2024 | Seatex, LLC | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated |
| Apr 1, 2024 | Seatex, LLC | Division of Pharmaceutical Quality Operations II | 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 |
|---|---|---|---|
| Apr 30, 2024 | Avaria Health & Beauty Corp. | Drugs | Canada |
| Apr 30, 2024 | Hemarus LLC | Biologics | United States |
| Apr 26, 2024 | Eden F&C, Co., Ltd. | Food/Cosmetics | Korea (the Republic of) |
| Apr 26, 2024 | Estancia La Paz SA | Food/Cosmetics | Argentina |
| Apr 26, 2024 | New Manna Foods | Food/Cosmetics | United States |
| Apr 26, 2024 | PetDine, LLC. | Veterinary | United States |
| Apr 25, 2024 | Bernardo Farms, LLC. | Food/Cosmetics | United States |
| Apr 25, 2024 | KEY FOODS CO. | Food/Cosmetics | United States |
| Apr 25, 2024 | LA YONGJIA TRADE CO | Food/Cosmetics | United States |
| Apr 25, 2024 | SILLIKER INC | Drugs | United States |
| Apr 25, 2024 | WISSNER-BOSSERHOFF GMBH | Devices | Germany |
| Apr 25, 2024 | Z-SYSTEMS AG | Devices | Switzerland |
| Apr 23, 2024 | Zydus Lifesciences Limited | Drugs | India |
| Apr 19, 2024 | AJL Ophthalmic S.A | Devices | Spain |
| Apr 19, 2024 | Mehran Michael Bahrami, M.D. | Drugs | United States |
| Apr 19, 2024 | Soliteint Cosmetics KFT | Drugs | Hungary |
| Apr 18, 2024 | Micro Orgo Chem | Drugs | India |
| Apr 17, 2024 | KALO Foods, LLC | Food/Cosmetics | United States |
| Apr 17, 2024 | Mark Savant, M.D. | Drugs | United States |
| Apr 17, 2024 | Multaler Et Cie S.A.S. | Drugs | France |
| Apr 12, 2024 | Appleton City Feed Service LLC | Veterinary | United States |
| Apr 12, 2024 | J & H Imports Services Corp. | Food/Cosmetics | United States |
| Apr 12, 2024 | MAKRA KOZMETIKA D.O.O. | Drugs | Slovenia |
| Apr 11, 2024 | Vape Game LLC | Tobacco | United States |
| Apr 5, 2024 | 100Misterios, LDA | Food/Cosmetics | Portugal |
| Apr 5, 2024 | Dr. Brite LLC | Drugs | United States |
| Apr 5, 2024 | Greco Gas, Inc. | Drugs | United States |
| Apr 5, 2024 | Han C. Phan, M.D. | Drugs | United States |
| Apr 5, 2024 | SAN-REY PRODUCE | Food/Cosmetics | United States |
| Apr 4, 2024 | Euphrates Food, LLC | Food/Cosmetics | United States |
| Apr 3, 2024 | Imprimis NJOF, LLC | Drugs | United States |
| Apr 3, 2024 | Jagsonpal Pharmaceuticals Ltd. | Drugs | India |
| Apr 2, 2024 | Nang Kuang Pharmaceutical Co., Ltd. | Drugs | Taiwan |
| Apr 1, 2024 | Warbucks Seafood Ny Llc | 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 | 45 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 24 |
| 21 CFR 123.6(b) | No HACCP plan | 19 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 18 |
| 21 CFR 117.40 | Equipment and utensils - Design and maintenance | 17 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 16 |
| 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls | 14 |
| 21 CFR 312.60 | Informed consent | 14 |
| 21 CFR 1.505(a)(2) | Evaluation - performance, risk | 13 |
| 21 CFR 211.192 | Written record of investigation incomplete | 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 |
|---|---|---|---|
| Apr 30, 2024 | ZOLL Medical Corporation | Devices | Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Patient Safety Ventilator MRI information… |
| Apr 29, 2024 | ARROW INTERNATIONAL Inc. | Devices | Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious… |
| Apr 29, 2024 | ARROW INTERNATIONAL Inc. | Devices | Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious… |
| Apr 29, 2024 | ARROW INTERNATIONAL Inc. | Devices | Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious… |
| Apr 29, 2024 | Hikma Injectables USA Inc | Drugs | Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine. |
| Apr 26, 2024 | Gibson Farms Inc | Food | Potential E. coli O157:H7 contamination. |
| Apr 24, 2024 | Tama Corporation | Food | Potential contamination with Listeria Monocytogenes |
| Apr 22, 2024 | Stop Clopez Corp | Drugs | Marketed Without An Approved NDA/ANDA |
| Apr 20, 2024 | Revive Rx LLC Dba Revive Rx Pharmacy | Drugs | Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate |
| Apr 18, 2024 | Graceleigh, Inc. Dba Sammy's Milk | Food | FDA inspection and investigation of firm's website and social media pages found that Sammy's online marketing materials included misleading… |
| Apr 18, 2024 | Graceleigh, Inc. Dba Sammy's Milk | Food | FDA inspection and investigation of firm's website and social media pages found that Sammy's online marketing materials included misleading… |
| Apr 18, 2024 | OptumHealth Care Solutions LLC | Devices | Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the market due to multiple potential failure… |
| Apr 16, 2024 | Infinite Herbs, LLC | Food | Salmonella typhimurium in organic basil |
| Apr 15, 2024 | NATURAL SOURCING INTERNATIONAL,LLC | Food | Salmonella contamination |
| Apr 11, 2024 | Roly-Poly Bakery | Food | Product contains undeclared egg. |
| Apr 9, 2024 | Gracie's Kitchens Inc. | Food | Product contains undeclared wheat and sesame. |
| Apr 8, 2024 | D-Lo's Gourmet Cheesecake | Food | Undeclared wheat, soy, colors (yellow 5 and blue 1), incomplete contains statement |
| Apr 8, 2024 | Dr. Reddy's Laboratories, Inc. | Drugs | Sub-potent Drug; powder discoloration associated with decreased potency |
| Apr 8, 2024 | Dr. Reddy's Laboratories, Inc. | Drugs | Sub-potent Drug; powder discoloration associated with decreased potency |
| Apr 8, 2024 | MEDLINE INDUSTRIES, LP - Northfield | Devices | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other… |
| Apr 8, 2024 | MEDLINE INDUSTRIES, LP - Northfield | Devices | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other… |
| Apr 8, 2024 | MEDLINE INDUSTRIES, LP - Northfield | Devices | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other… |
| Apr 8, 2024 | Vyaire Medical, Inc. | Devices | Potential of the nozzle separating during patient use. |
| Apr 5, 2024 | GLOBAL MIX INC. | Food | Product contains Yellow Oleander |
| Apr 3, 2024 | World Green Nutrition Inc. | Food | FDA Analysis found product labeled as tejocote is actually yellow oleander, which is toxic to humans. |
| Apr 1, 2024 | Philips Respironics, Inc. | Devices | Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild… |
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