[U.S. Food and Drug Administration]

FOIA WARNING LETTERS SEARCH


Warning Letters Index by Subject
Devices/Surgical Instruments (1) Acidified Food Products (2)
Acidity Levels (2) Active Pharmaceutical Ingredient (4) Adultered Devices (2)
Airline Lavatory Services (1) Airline Meals (4) Airline Support Facility (2)
Airline Waste Service (4) Analytical Methodology (1) Analytical Testing (1)
Animal Drugs (2) API Products (1) Approved Labeling (1)
Backflow Prevention Device (2) Baked Food (1) Billing Practices (1)
Bio-Oxy (1) Bio-Oxygen (1) Bioengineered Human Replacement Dermis [skin] (1)
Biologic Drugs (1) Biologics (7) Biopsy Forceps (1)
Blood & Blood Components (2) Blood Bags (1) Blood Bank (8)
Blood Bank Software (1) Blood Products (29) Blood Products/Physicians Certification (1)
Bone Density Mineral Assessment System (1) Bottled Drinking Water (4) Bulk Drug Substances (2)
Bulk Pharmaceutical Chemicals (1) Bus Services (1) Canned Foods (1)
Cardiac Catherization Monitoring System (1) Catering Facilities (1) Catheters & Vascular Access Ports (1)
Caviar Repackaging (1) CGMP Deviations (1) Clindamycin Hydrochloride (1)
Clinical Studies (12) Colon Hydrotherapy (1) Communicable Diseases and Interstate Conveyance (1)
Compressed Oxygen (1) Computer Systems (1) Comtaminated Water / Federal Regulations Interstate Conveyance (1)
Contact Lenses (1) Coronary Stent System (1) Cosmetics (2)
Cosmetics/Shampoo (2) Cosmetics/Skin-Cap Shampoo (1) Crabmeat Processing (1)
Custom Sterile Procedure Kits (1) Dairy Products (14) Deionized Water System (1)
Dental Devices (1) Dental Implants (2) Detoxification Program (1)
Deviation from applicable Standard Operating Procedures (1) Deviation from Good Manufacturing Practice (27) Deviation from Good Manufacturing Practice / Medical Devices (1)
Deviations from applicable Standard Operating Procedures (1) Devices (52) Devices/Adapters (1)
Devices/anti-HIV-1 Western Blot (1) Devices/Backflow prevention (1) Devices/Balloon Therapy (1)
Devices/Biopsy Needles (1) Devices/Bipolar Forceps (1) Devices/Blood Pressure Monitoring System (1)
Devices/Bone Densitometers (1) Devices/Breast Implants (1) Devices/Breast Pump Kit (1)
Devices/Carotid Shunts (1) Devices/Catheters (5) Devices/Cervical Plate Systems (1)
Devices/Colonic Irrigation Systems (1) Devices/Colostomy Rods & Ileostomy/Colostemy/Urostomy Bags (1) Devices/Computer Software (1)
Devices/Computer Systems (2) Devices/Contact Lenses (3) Devices/Corn and Callus Removers (1)
Devices/Crystal Stimulator (1) Devices/Defibrillators (1) Devices/Dental (1)
Devices/Dental Instruments (2) Devices/Dental X-ray Systems (2) Devices/Diagnostic Systems (4)
Devices/Earplanes (1) Devices/ECG Monitors (2) Devices/ElecDT & VacuPulls (1)
Devices/Electrometers Dosemeters (1) Devices/Electrosurgical Probes (1) Devices/Endoscope and Endotherapy Systems (1)
Devices/Endosseous Implants (1) Devices/Excimer Laser (1) Devices/Eye Center (3)
Devices/Flowmeters (1) Devices/Gastrostomy Kits (1) Devices/H-Wave Muscle Stimulator (2)
Devices/Hearing Aid (3) Devices/Hearing Aids (1) Devices/Hemodialysis Systems (1)
Devices/HIV Test Kit (6) Devices/Hospital Beds (1) Devices/Imaging Kit (1)
Devices/Implants (1) Devices/Implementing Regulations (1) Devices/In-vitro Diagnostic biologicals (1)
Devices/Infusion Sets (2) Devices/Injection System (1) Devices/InstaTrak System (1)
Devices/Intraocular Lenses (2) Devices/Laser Eye (1) Devices/Laser Systems (25)
Devices/Latex Gloves (3) Devices/Magnetic Belts and Straps (1) Devices/Medical Gas Analyzers (1)
Devices/Medical Laser (1) Devices/Micro Reader III and HyPrep Plus (1) Devices/Microhematocrit Centrifuge (1)
Devices/Microvascular Anastomotic System (1) Devices/Monitoring System (1) Devices/MRX Microplate Readers (1)
Devices/Octyldent (1) Devices/Ophthalmic Diagnostic Units (1) Devices/Orthopedic Implants (1)
Devices/Orthopedic Instruments (1) Devices/Orthopedic Screws (1) Devices/Oximeter Finger Sensor & Cables (1)
Devices/Ozone Generators (1) Devices/Paste Products (1) Devices/Patient Beds (1)
Devices/Phototherapy Systems (1) Devices/Plasma Collection Systems (1) Devices/Plasma Separators (1)
Devices/Podiatric (1) Devices/Pregnancy Test (1) Devices/Protheses (1)
Devices/Rejuveness Silicone (1) Devices/Resuscitators (2) Devices/Sanitation (1)
Devices/Sculpting System (1) Devices/Sharps Containers (1) Devices/Shortwave Daithermy Device (1)
Devices/Sponges (1) Devices/Sterile insufflation tubing sets (1) Devices/Sterile Products (2)
Devices/Sunlamps (1) Devices/Surgical and Dental Instruments (1) Devices/Surgical Instruments (13)
Devices/Syringes (1) Devices/Tectonic Magnets (1) Devices/Teleradiology System (1)
Devices/Test Kits (6) Devices/Test Strips (2) Devices/Tomography (1)
Devices/Toothbrush Systems (1) Devices/Trocar (1) Devices/Utrasonic Therapy (1)
Devices/Wound Dressing (1) Devices/Wound Gel & Dressing (1) Devices/X-ray Equipment (4)
Devices/X-ray Systems (1) Diagnostic X-ray Equipment (2) Diagnostic X-ray Equipment (Performance Standards) (1)
Dietary Supplement/Plantain (6) Dietary Supplements (2) Drug Component Ingredients (1)
Drug Products (97) Drug Products/Advertising (1) Drug Products/Antifungal Solution & Wash (1)
Drug Products/Antimicrobial Soap (1) Drug Products/Aquaprin (1) Drug Products/BeneFin & SkinAnswer (1)
Drug Products/Deodorant Spray (1) Drug Products/Friatroy (1) Drug Products/GMP (1)
Drug Products/Imorphint Sulfate Tablets (1) Drug Products/Labeling (1) Drug Products/MaxAlert (1)
Drug Products/Megestrol Acetate Tablets (1) Drug Products/Ophthalmic Solutions (2) Drug Products/Pediculicides (1)
Drug Products/SPV-30 Herbal Extract (1) Drug Products/Sterility (1) Drug Products/Testing (2)
Drug Products/Theophylline (1) Drug Products/Topical Aspirin (1) Drug Products/Weight Loss (1)
Drug Repacking and Relabeling (1) Electroencephalograph Devices (1) Electrophysiology Catheters (1)
Electrosurgical Probes (1) Esophageal Probes (1) Ethylene Oxide Sterilization (1)
Excimer Laser Standards (1) Eye & Tissue Transplant Bank (1) Eye Lubricant (1)
False and Misleading Advertising (1) Finished Pharmaceuticals (5) Fluorescent Pattern Monitors (1)
Food (40) Food / Animal for Slaughter (1) Food / Candy (1)
Food / Cheese Products (1) Food / Cooked Shrimp (1) Food / Fish (1)
Food / Flavored Raisins (1) Food / Frozen Shrimp (1) Food / Fruits (1)
Food / Fruits and Vegetables (2) Food / Insanitary Conditions (1) Food / Juice (1)
Food / Mushrooms (2) Food / Slaughtered Animals (1) Food / Swine (2)
Food / Tuna (1) Food / Vegetables (2) Food Labeling (1)
Food Processing (1) Food Processing Violations (1) Food Products (3)
Food/Bread (1) Food/Candy (2) Food/Canned (1)
Food/Cattle (95) Food/Caviar (1) Food/Crabmeat (6)
Food/Enzymes (1) Food/Fish (4) Food/Fresh Fruit (1)
Food/Human (3) Food/Infant Formula (1) Food/Juice Products (1)
Food/Labeling (1) Food/Nuts (1) Food/Pickles (1)
Food/Sanitation (3) Food/Seafood (1) Food/Shipment (2)
Food/Shrimp (2) Food/Tofu (1) Fresh Dolphin / Mahi-Mahi (1)
Generic Drug Products (1) GLP (1) GLP Deviations (1)
Good Manufacturing Practices / Quality System Regulations (1) Health and Safety Violations (2) Heart Rate Monitor (1)
Hemodialysis Catheters (1) Hemodialysis Devices (4) Herbal Products (1)
Herpetrol Coated Tablets (1) High Density Polyethylene Bottles (1) Hospital Blood Bank (1)
Human Research Subjects Protection (2) Hydralazine Hydrochloride (1) Import Products (5)
In Vitro Diagnostic Analyzers (1) In Vitro Diagnostic Kits & Reagents (1) In Vitro Diagnostic Products (13)
In-Vitro Diagnostics (1) Injectable Cytokine Mixture (1) Insanitary Conditions (59)
Interactive Database (1) Interstate Conveyance Sanitation (1) Intraoral Cameras and Accessories (1)
Investigational Device Exemptions (1) Investigational New Drugs (1) Investigational Review Board Procedures (3)
IRB Procedures (2) Irradiated Products (1) Labeling (47)
Labeling / New Drug Application (2) Labeling / Tea Tree Oil (1) Labeling and Promotional Violations (1)
Labeling/Cheese (1) Labeling/Fen-Phen (1) Labeling/Food Products (1)
Labeling/Frankfurter Products (1) Labeling/Ginseng Products (1) Labeling/Herbal Tonic (1)
Labeling/Honey (2) Labeling/Lemon Juice (1) Labeling/Makeup (2)
Labeling/Roasted Peanuts (1) Labeling/Smoked Salmon (1) Labeling/Softgels (1)
Labeling/Spray Formula (1) Labeling/Tpros (1) Lasaer / Distance Mesasuring Device (1)
Laser / Performance Standards (1) Laser Imaging Systems (1) Laser Performance Standards (1)
Laser Product Performance Standard (1) Lavatory Services (4) Laxative Products (1)
Liquid & Compressed Oxygen (1) Liquid & Gas Oxygen (1) Liquid and Compressed Oxygen (1)
Liquid Medical Oxygen (1) Liquid Nitrogen (1) Liquid Oxygen (17)
Low Acid Canned Foods (1) Mammography Standards (145) Medical Device / Body Fluid Pouch (1)
Medical Device / Laser (1) Medical Device Reporting (1) Medical Devices (66)
Medical Devices / [QSRs] Quality System Requirements Deficiencies (3) Medical Devices/Infusion Pumps (1) Medical Kits / GMPV (1)
Medical Oxygen (167) Medical Oxygen and Nitrogen (1) Medicated Articles (1)
Medicated Feeds (36) Methadone (1) Microwave Oven (1)
Microwave Ovens (2) Narcotic Treatment Program (2) Narcotic Treatment Program Standards (8)
Narcotics Treatment Program Standards (1) Nasal Spray (1) Natural Latex Condoms (1)
Needle Electrodes (1) New Animal Drug Application (1) New Animal Drug Product (7)
New Drug Application (7) New Drugs (1) Non Sterile Examination Gloves (1)
Nutrient Supplement Manufacturing Facility (1) Nutrition Labeling (1) Obstetric/Gynecological Devices (1)
Octopus Shipment (1) Over the Counter Drug Products (2) Oxygen Analyzers (1)
Packaging Materials (1) Passenger Bus Waste Services (1) Performance Standards / Diagnostic X-Ray Equipment (1)
Phencal (1) Plague Vaccine (1) Plasmapheresis (1)
Powder & Gel Wound Dressing (1) Premarket Approval Application [PMA] (1) Prescription Drug Products (3)
Prescription Drugs (1) Procedural Kits (1) Product Deficiencies (1)
Production Procedures (1) Promotional & Labeling Violations (1) Protein Supplements (1)
Quality Control & Testing / Radiation Control (2) Quality Control Violations (1) Quality System Regulations / Medical Devices (2)
Shipment Documentation (1) Silicone Products (1) Skin-Cap Spray (1)
Sobriety Aid (1) Source Plasma Control Violations (1) Sterile and Bulk Drug Products (1)
Sterile Electrolysis Needles (1) Sterile Gowns and Drapes (1) Sterile Pharmaceutical Chemicals (1)
Sterile Pharmaceutical Products (1) Sterile Surgeon Gowns & Gloves (1) Sugardyne Skin Wound Protectant (1)
Summit Technology Omnimed Excimer Laser (1) Sunlamp Products (1) Sunscreen (1)
Sunscreen Products (1) Suntanning Products (3) Surgical and Dental Hand Instruments (1)
Surgical and Dental Instruments (1) Syringe Infusion Pump (1) Syrup Products (1)
Tanning Beds (10) Therapy Devices (2) Topical Liquid Drug Products (1)
Transdermal Nitroglycerin (1) Tubing Sets (1) Turtles (1)
Ultrasonic-Dissection/Aspiration (1) Unapproved New Drug (1) Undeclared Drug Claims (1)
Variegate Products (1) Vessel Watering Points (53) Veterinary Drugs (12)
Veterinary Drugs / Finished Pharmaceuticals (1) Veterinary Homeopathic Products (1) Veterinary Medicine (4)
Violation of Conveyance Sanitation Regulations (1) Violations / Conveyance Sanitation Regulatons (1) Vitro Diagnostic Products (2)
Water Filled Soothers / Teething Rings (1) Water Hydrants (4) Watering Piping (2)
Written Standard Operating Procedures (3) X-Ray Bone Densitometer (1) X-Ray Systems (1)
X-Ray Tables and Tube Stands (1)

Company Warning Letters Index

Subject Warning Letters Index

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Last Updated on 8/10/98