FDA Warning Letters, 483s and Recalls: September 2021
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 |
|---|---|---|---|
| Sep 30, 2021 | GuangZhou YouXing Cosmetic Co., Ltd | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Sep 30, 2021 | Limpo Quimicos, SA De CV | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Sep 30, 2021 | Marcus Research Laboratory, Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Sep 30, 2021 | Missouri Analytical Laboratories Inc | Division of Pharmaceutical Quality Operations III | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Sep 30, 2021 | RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc. | Center for Drug Evaluation and Research | CDER | Bioresearch Monitoring Program/IRB |
| Sep 29, 2021 | HealthMEDS Inc. | Center for Drug Evaluation and Research | CDER | Failure to permit access to or copying of records |
| Sep 29, 2021 | Healthy Foods & Nutrition Lab De Mexico S.A. De C.V. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| Sep 29, 2021 | True Chemical Solutions, LLC | Center for Drug Evaluation and Research | CDER | Failure to Permit Access to or Copying of Records |
| Sep 28, 2021 | Strategia Project Management, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19) |
| Sep 24, 2021 | Chameleon Beverage Co. Inc. Dba Chameleon Sanitizer Corporation | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 22, 2021 | Ardil Comercial S.R.L. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Sep 22, 2021 | Supplement Science Corp. D/B/A Condemned Labz | Office of Human and Animal Food Operations East – Division 1 | Unapproved New Drugs/Misbranded |
| Sep 22, 2021 | The Camel Milk Co. LLC Dba Camel Culture | Office of Human and Animal Foods Operations – Division West 4 | New Drug/Misbranded |
| Sep 21, 2021 | Sircle Laboratories, LLC | Office of Pharmaceutical Quality Operations, Division II | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 20, 2021 | Apothecary Health Solutions/Right Value Drug Stores, LLC Dba Carie Boyd's Prescription Shop | Office of Pharmaceutical Quality Operations, Division II | Compounding Pharmacy/Adulterated Drug Products |
| Sep 20, 2021 | ICA Health, LLC/Future Formulations, LLC | Office of Human and Animal Foods Operations – Division West 4 | New Drug/Misbranded |
| Sep 17, 2021 | Magnolia Medical Technologies, Inc. | Office of Medical Devices and Radiological Health, Division 3 | CGMP/QSR/Medical Devices/Adulterated |
| Sep 17, 2021 | Walfer Corporation Dba The Medicine Shoppe Pharmacy | Office of Pharmaceutical Quality Operations, Division II | Compounding Pharmacy/Adulterated Drug Products |
| Sep 15, 2021 | D&C Seafood, Inc | Division of Human and Animal Food Operations East V | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Sep 15, 2021 | Dulces La Mejor, LLC | Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Sep 15, 2021 | Laboratorio Pharma International SRL | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Sep 15, 2021 | Lewiston Feed & Produce Company | Office of Human and Animal Foods – West Division | CGMP/Medicated Feeds/Adulterated |
| Sep 15, 2021 | Nanomateriales Químicos Avanzados, S.A. De C.V. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Sep 13, 2021 | Furley Bioextracts SDN BHD | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Sep 10, 2021 | Holographic Health, Inc. | Division of Human and Animal Food Operations East V | New Drug/Misbranded |
| Sep 8, 2021 | Chula Vista Imports Ltd. | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) |
| Sep 7, 2021 | Aceva, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| Sep 7, 2021 | Ar-Rahman Pharm LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| Sep 7, 2021 | Holistic Healer & Wellness Center, Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| Sep 7, 2021 | Live Good Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| Sep 7, 2021 | Lysulin, Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| Sep 7, 2021 | McDaniel Water, LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| Sep 7, 2021 | Metamune Inc | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| Sep 7, 2021 | Nuturna International LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| Sep 7, 2021 | Pharmaganics LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| Sep 7, 2021 | Phytag Labs | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| Sep 7, 2021 | Radhanite, LLC D/B/A Curalife Ltd | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| Sep 7, 2021 | Selected Food & Beverage, Inc. | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Sep 3, 2021 | Databazaar.Com | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 |
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 |
|---|---|---|---|
| Sep 30, 2021 | Patanjali Ayurved Limited | Food/Cosmetics | India |
| Sep 30, 2021 | Preservation Solutions, Inc. | Devices | United States |
| Sep 30, 2021 | Signature Formulations, LLC | Drugs | United States |
| Sep 30, 2021 | SSG Ventures | Drugs | United States |
| Sep 29, 2021 | Premier Trends LLC | Drugs | United States |
| Sep 29, 2021 | Tenderneeds Fertility LLC | Devices | United States |
| Sep 29, 2021 | The Compounding Pharmacy | Drugs | United States |
| Sep 28, 2021 | Nutritional Laboratories International Inc | Food/Cosmetics | United States |
| Sep 27, 2021 | Euphrates Food, LLC | Food/Cosmetics | United States |
| Sep 27, 2021 | TAKA USA, INC. | Drugs | United States |
| Sep 24, 2021 | Cetylite Industries, Inc. | Drugs | United States |
| Sep 24, 2021 | Fenwal International, Inc. | Biologics | United States |
| Sep 24, 2021 | Lusys Laboratories, Inc. | Devices | United States |
| Sep 24, 2021 | Oregons Wild Harvest Inc | Food/Cosmetics | United States |
| Sep 24, 2021 | Paramesh Banerji Life Sciences, LLC | Drugs | United States |
| Sep 24, 2021 | Potenergy Natural Foods | Food/Cosmetics | United States |
| Sep 24, 2021 | Yusef Manufacturing Laboratories, LLC | Drugs | United States |
| Sep 23, 2021 | Tender Corporation D/B/A Adventure Ready Brands | Drugs | United States |
| Sep 22, 2021 | Health Pharma USA LLC | Drugs | United States |
| Sep 22, 2021 | Pharmco Laboratories Inc. | Drugs | United States |
| Sep 22, 2021 | Sofie Co. | Drugs | United States |
| Sep 22, 2021 | Vitae Enim Vitae Scientific, Inc. | Drugs | United States |
| Sep 21, 2021 | Saad Trading Inc | Food/Cosmetics | United States |
| Sep 21, 2021 | Sabine S. Hazan, M.D. | Biologics | United States |
| Sep 20, 2021 | Logix Biosciences Inc. | Drugs | United States |
| Sep 17, 2021 | Alora Pharmaceuticals LLC | Drugs | United States |
| Sep 17, 2021 | CardioQuip, LLC | Devices | United States |
| Sep 17, 2021 | DING TEA BALBOA | Food/Cosmetics | United States |
| Sep 17, 2021 | Sky Medical Supplies And Equipments, LLC | Devices | United States |
| Sep 16, 2021 | Brigham And Women's Hospital, Inc., The | Drugs | United States |
| Sep 16, 2021 | International Trading Pharm Lab Inc | Drugs | United States |
| Sep 15, 2021 | Froggy's Fog LLC | Drugs | United States |
| Sep 15, 2021 | Joseph Anderson | Tobacco | United States |
| Sep 15, 2021 | Picket Fence Creamery, L.L.C. | Food/Cosmetics | United States |
| Sep 15, 2021 | Seaway Pharma Inc. | Drugs | United States |
| Sep 14, 2021 | Medina Baking And Powder Products, Inc. | Food/Cosmetics | United States |
| Sep 14, 2021 | Molino Food Livel Corp | Food/Cosmetics | United States |
| Sep 14, 2021 | ULTRAtab Laboratories, Inc | Drugs | United States |
| Sep 14, 2021 | ULTRAtab Laboratories, Inc. | Drugs | United States |
| Sep 14, 2021 | Vasyl Melnyk | Drugs | Ukraine |
| Sep 14, 2021 | W.S. Badger Company, Inc. | Drugs | United States |
| Sep 10, 2021 | Best Buy Bones Inc. | Veterinary | United States |
| Sep 10, 2021 | Ecometics, Inc. | Drugs | United States |
| Sep 10, 2021 | MYA International, Inc | Food/Cosmetics | United States |
| Sep 10, 2021 | PATIDAR TRADE INC | Food/Cosmetics | United States |
| Sep 9, 2021 | DSP Skin Care LLC | Drugs | United States |
| Sep 8, 2021 | Apollo Care, LLC | Drugs | United States |
| Sep 8, 2021 | Felix Custom Smoking | Food/Cosmetics | United States |
| Sep 7, 2021 | Eli's Manhattan Warehouse Inc | Food/Cosmetics | United States |
| Sep 3, 2021 | Agroson's LLC | Food/Cosmetics | United States |
| Sep 3, 2021 | Athens Naval Hospital, Pulmonary Clinic | Drugs | Greece |
| Sep 3, 2021 | Hybrid Pharma LLC | Drugs | United States |
| Sep 2, 2021 | Bootstrap Runners LLC | Tobacco | United States |
| Sep 2, 2021 | Midwest Sterilization Corporation | Devices | United States |
| Sep 1, 2021 | Living Foods LLC | Veterinary | United States |
| Sep 1, 2021 | Sunshine Mills, 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 | 100 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 29 |
| 21 CFR 117.35(c) | Pest control | 21 |
| 21 CFR 211.192 | Written record of investigation incomplete | 21 |
| 21 CFR 123.6(b) | No HACCP plan | 20 |
| 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition | 19 |
| 21 CFR 117.10 | Personnel | 19 |
| 21 CFR 117.80(c) | Process Control Measures | 19 |
| 21 CFR 211.22(d) | Procedures not in writing, fully followed | 18 |
| 21 CFR 117.35(d) | Sanitation of food-contact surfaces - Frequency | 16 |
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 |
|---|---|---|---|
| Sep 30, 2021 | Beiersdorf Inc | Drugs | Chemical contamination; presence of benzene |
| Sep 30, 2021 | Beiersdorf Inc | Drugs | Chemical contamination; presence of benzene |
| Sep 30, 2021 | Beiersdorf Inc | Drugs | Chemical contamination; presence of benzene |
| Sep 30, 2021 | Beiersdorf Inc | Drugs | Chemical contamination; presence of benzene |
| Sep 30, 2021 | Beiersdorf Inc | Drugs | Chemical contamination; presence of benzene |
| Sep 30, 2021 | Best Foods NJ, Inc. | Food | Undeclared sulfites |
| Sep 29, 2021 | B&G Foods North America, Inc | Food | Product was recalled due to the presence of undeclared wheat. |
| Sep 24, 2021 | Cuisine Innovations Unlimited, LLC | Food | Undeclared egg |
| Sep 24, 2021 | Eli Lilly & Company | Drugs | SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect… |
| Sep 22, 2021 | MEDTECH SAS | Devices | The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an… |
| Sep 22, 2021 | Whole Foods Market Brand 365, Llc | Food | Whole and sliced Apple and Cherry Pies from five stores in the Mid-Atlantic Region contain undeclared milk and egg. |
| Sep 22, 2021 | Whole Foods Market Brand 365, Llc | Food | Whole and sliced Apple and Cherry Pies from five stores in the Mid-Atlantic Region contain undeclared milk and egg. |
| Sep 21, 2021 | Datascope Corp. | Devices | A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal… |
| Sep 20, 2021 | Arrow International Inc | Devices | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with… |
| Sep 20, 2021 | Arrow International Inc | Devices | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with… |
| Sep 20, 2021 | Arrow International Inc | Devices | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with… |
| Sep 20, 2021 | Arrow International Inc | Devices | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with… |
| Sep 20, 2021 | Litehouse Inc | Food | Undeclared anchovies. |
| Sep 16, 2021 | The Earl Of Sandwiches | Food | Sandwiches may contain undeclared egg. |
| Sep 16, 2021 | The Earl Of Sandwiches | Food | Sandwiches may contain undeclared soy and egg. |
| Sep 16, 2021 | The Earl Of Sandwiches | Food | Sandwiches may contain undeclared soy and egg. |
| Sep 16, 2021 | The Earl Of Sandwiches | Food | Sandwiches may contain undeclared soy and egg. |
| Sep 16, 2021 | The Earl Of Sandwiches | Food | Sandwiches may contain undeclared soy and egg. |
| Sep 15, 2021 | Terry And Joe Baker Farms, Llc Dba Baker Farms | Food | The firm was notified by one of their customers that during a random testing by ODA the product test positive for Listeria monocytogenes. |
| Sep 15, 2021 | The Kroger Co | Food | Potential contamination with Listeria Monocytogenes |
| Sep 9, 2021 | Jacobus Pharmaceutical Company Inc. | Drugs | Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold… |
| Sep 9, 2021 | Medina Baking And Powder Products, Inc. | Food | Undeclared Egg |
| Sep 9, 2021 | Medina Baking And Powder Products, Inc. | Food | Undeclared Egg, Yellow #5, Red #40, and Blue #1. |
| Sep 9, 2021 | Vero Biotech, LLC | Devices | Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of… |
| Sep 7, 2021 | DJO, LLC | Devices | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA… |
| Sep 7, 2021 | DJO, LLC | Devices | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA… |
| Sep 6, 2021 | Velvet Ice Cream Company | Food | Undeclared Allergen |
| Sep 3, 2021 | ICU Medical Inc | Drugs | Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found… |
| Sep 3, 2021 | Whole Foods Market Brand 365, Llc | Food | Undeclared milk and egg |
| Sep 2, 2021 | Abbott Molecular, Inc. | Devices | There is a potential for false positive results. |
| Sep 2, 2021 | Abbott Molecular, Inc. | Devices | There is a potential for false positive results. |
| Sep 2, 2021 | Abbott Molecular, Inc. | Devices | There is a potential for false positive results. |
| Sep 2, 2021 | Abbott Molecular, Inc. | Devices | There is a potential for false positive results. |
| Sep 2, 2021 | Abbott Molecular, Inc. | Devices | There is a potential for false positive results. |
| Sep 2, 2021 | Deroyal Industries, Inc. Lafollette | Devices | DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming System which is recalled due to the potential… |
| Sep 1, 2021 | Weis Markets, Inc., Ice Cream Division | Food | Undeclared milk |
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.