Warning Letters Matter

Warning Letters Matter

Posted by Kim Egan  on June 27, 2012

Attached is our monthly summary of selected FDA Warning Letters recently made public by FDA. Of particular note:

FDA cited one manufacturer of drug components and its immediate shipper for violation of Import for Export provisions because of failure to provide IFE records and a report, despite multiple requests by FDA.

FDA issued a warning letter to one company for promoting unapproved new drugs that made unsubstantiated claims about treatment of a wide variety of conditions, including cancer, autism, schizophrenia, multiple sclerosis, hepatitis C, and HIV infection.

FDA cited another company for making unsubstantiated therapeutic claims, including treatment of cancer and Alzheimer’s disease, about its mushroom supplements that FDA considered unapproved new drugs. In addition to inclusion of these claims on the company’s website, they were also supplemented by metatags used to bring consumers to the site.

FDA issued a warning letter to the manufacturer of a laser system for the unapproved new use of a device, as well as violation of Electronic Product Radiation Control requirements because of failure to submit product reports and file its annual report.

FDA also cited a tobacco company for violating the agency’s regulations restricting the sale and distribution of tobacco products to minors by promoting its “No Nonsense Rewards” program, wherein customers were offered a check in exchange for providing proof of purchase of specially marked packages of the company’s moist snuff product.

FDA continues to focus on Good Manufacturing Practices and posted warning letters for the following devices: steam sterilizers, an anti-embolism wrap system, lower limb prosthetics, bone densitometers, anesthetic delivery systems and respiratory therapy equipment, contact lenses, external penile rigidity devices, infusion pumps and urological catheters, neurosurgery and hemostatic devices, wound and burn dressings, temperature indicators, dental prosthetics, plasma coagulation control devices, an enteral infusion pumps, sterile syringes, an orthogonal percussion adjusting instrument, a turning medical bed, a pharmaceutical compounding device, telemetry devices, electrocardiogram monitoring equipment and software devices, a non-sterile blood pressure monitor, a total knee replacement system, a ventricular assist system, and a powered muscle stimulator device. In addition to the cGMP violations, FDA cited twelve companies for MDR violations, two for unapproved devices, two for unapproved new uses of a device, one for Report of Corrections and Removal violations, and two for Registration and Listing violations.

FDA also posted seven warning letter for cGMP violations regarding finished pharmaceuticals and dietary supplements. In addition to the cGMP violations, FDA cited one company for labeling violations, and one company for unapproved new drugs and field alert report violations.

The statistics are:

- 24 letters re cGMP device violations;

- 9 letters re medical device reporting (Animas Corporation (including cGMP violations), Health Science Products, Incorporated (including cGMP violations), APC Medical Limited (including cGMP and registration and listing violations), Teh Lin Prosthetic & Orthopedic, Inc. (including cGMP violations), Sorin Group Deutschland GmbH (including cGMP violations), The Lasik Vision Institute, Newman Lasik Centers LLC, Soring Medical Technology (including cGMP violations) and Okamoto Industries Inc. (including cGMP violations));

- 7 letters re cGMP pharma violations;

- 6 letters re unapproved new drugs (Herbal Extracts Plus, LLC, Agora Publishing Inc., Natural Health Team, The hCG Drops LLC, Mushroom Wisdom, Inc., and BioAnue Laboratories, Inc.);

- 3 letters re unapproved new use of devices (Medical Quant USA (including cGMP violations), Merit Medical Ireland Ltd. and BioElectronics Corporation);

- 2 letters re unapproved new devices (Akers Biosciences, Inc., and Spencer Forrest, Inc.);

- 2 letters re tobacco product marketing and sales (The Pinkerton Tobacco Company and Tobacco Source Three LLC);

- 1 letter re an unapproved new OTC homeopathic (Schwabe North America, Inc.);

- 1 letter re an unapproved new dietary supplement (Almased USA, Inc.);

- 1 letter re unapproved new use of an OTC device (CuraeLase, Inc. (including cGMP and MDR violations));

- 1 letter re drug study violations (Betty Tuller, Ph.D.); and

- 1 letter re import for export (MedPharm, LLC).

Here is our monthly summary of selected FDA Warning Letters recently made public by FDA. The statistics for this report:

- 24 letters re cGMP device violations;

- 9 letters re medical device reporting (Animas Corporation (including cGMP violations), Health Science Products, Incorporated (including cGMP violations), APC Medical Limited (including cGMP and registration and listing violations), Teh Lin Prosthetic & Orthopedic, Inc. (including cGMP violations), Sorin Group Deutschland GmbH (including cGMP violations), The Lasik Vision Institute, Newman Lasik Centers LLC, Soring Medical Technology (including cGMP violations) and Okamoto Industries Inc. (including cGMP violations));

- 7 letters re cGMP pharma violations;

- 6 letters re unapproved new drugs (Herbal Extracts Plus, LLC, Agora Publishing Inc., Natural Health Team, The hCG Drops LLC, Mushroom Wisdom, Inc., and BioAnue Laboratories, Inc.);

- 3 letters re unapproved new use of devices (Medical Quant USA (including cGMP violations), Merit Medical Ireland Ltd. and BioElectronics Corporation);

- 2 letters re unapproved new devices (Akers Biosciences, Inc., and Spencer Forrest, Inc.);

- 2 letters re tobacco product marketing and sales (The Pinkerton Tobacco Company and Tobacco Source Three LLC);

- 1 letter re an unapproved new OTC homeopathic (Schwabe North America, Inc.);

- 1 letter re an unapproved new dietary supplement (Almased USA, Inc.);

- 1 letter re unapproved new use of an OTC device (CuraeLase, Inc. (including cGMP and MDR violations));

- 1 letter re drug study violations (Betty Tuller, Ph.D.); and

- 1 letter re import for export (MedPharm, LLC).

And of particular note:

• FDA cited one manufacturer of drug components and its immediate shipper for violation of Import for Export provisions because of failure to provide IFE records and a report, despite multiple requests by FDA.
• FDA issued a warning letter to one company for promoting unapproved new drugs that made unsubstantiated claims about treatment of a wide variety of conditions, including cancer, autism, schizophrenia, multiple sclerosis, hepatitis C, and HIV infection.
• FDA cited another company for making unsubstantiated therapeutic claims, including treatment of cancer and Alzheimer’s disease, about its mushroom supplements that FDA considered unapproved new drugs. In addition to inclusion of these claims on the company’s website, they were also supplemented by metatags used to bring consumers to the site.
• FDA issued a warning letter to the manufacturer of a laser system for the unapproved new use of a device, as well as violation of Electronic Product Radiation Control requirements because of failure to submit product reports and file its annual report.
• FDA also cited a tobacco company for violating the agency’s regulations restricting the sale and distribution of tobacco products to minors by promoting its “No Nonsense Rewards” program, wherein customers were offered a check in exchange for providing proof of purchase of specially marked packages of the company’s moist snuff product.
• FDA continues to focus on Good Manufacturing Practices and posted warning letters for the following devices: steam sterilizers, an anti-embolism wrap system, lower limb prosthetics, bone densitometers, anesthetic delivery systems and respiratory therapy equipment, contact lenses, external penile rigidity devices, infusion pumps and urological catheters, neurosurgery and hemostatic devices, wound and burn dressings, temperature indicators, dental prosthetics, plasma coagulation control devices, an enteral infusion pumps, sterile syringes, an orthogonal percussion adjusting instrument, a turning medical bed, a pharmaceutical compounding device, telemetry devices, electrocardiogram monitoring equipment and software devices, a non-sterile blood pressure monitor, a total knee replacement system, a ventricular assist system, and a powered muscle stimulator device. In addition to the cGMP violations, FDA cited twelve companies for MDR violations, two for unapproved devices, two for unapproved new uses of a device, one for Report of Corrections and Removal violations, and two for Registration and Listing violations.
• FDA also posted seven warning letter for cGMP violations regarding finished pharmaceuticals and dietary supplements. In addition to the cGMP violations, FDA cited one company for labeling violations, and one company for unapproved new drugs and field alert report violations