Warning Letters Matter: Nov. 2011 Summary
FDA Warning Letters through November 2011 are now publicly available. Below is our summary of recent Warning Letters of particular interest.
- FDA cited one company for marketing chocolate as an unapproved new drug. The unauthorized health claims involved brain injury, cardiac mortality and tooth decay, among others. The company was also cited for food cGMP violations involving failure to properly clean the manufacturing facility.
- FDA cited a company misbranded cosmetics, one of which was a collagen cream containing “dribble of the snail,” because the ingredient was not declared in accordance with labeling requirements.
- FDA continues to monitor social media, and cited one company for promoting unapproved new drugs on its Facebook page.
- FDA cited one company for unapproved new devices in connection with its HIV saliva rapid screen test IVD.
- In a relatively unusual letter, FDA cited a hospital for repeat violations of mammography quality standards and indicated that, if the violations were not corrected, the agency may take additional action, including charging the hospital for the cost of on-site monitoring, civil money penalties of up to $10,000, and suspension or revocation of the hospital’s FDA certificate.
- FDA continues to focus on Good Manufacturing Practices and posted warning letters for the following devices: IVF devices, pediatric and adult temperature probes, dental x-ray automatic film processors, spinal and knee system devices, infant and neonatal CO2 filter devices, soft contact lenses, a TENS stimulator, and cervical and lumbar traction devices, dental bridge frameworks, nebulizers and thermometers, a therapeutic (incentive) spirometer, and compression devices.
The statistics are:
- 12 letters re cGMP pharma violations;
- 11 letters re cGMP device violations;
- 7 letters re unapproved new drugs (Nature’s Rite, LLC, Algonot, LLC, Focus Laboratories, Inc., Altaire Pharmaceuticals, Inc., Rose Stone Enterprises dba Hub Pharmaceuticals, LLC, NanoLiposomal Nutritionals, and Crescendo Therapeutics LLC (including postmarketing adverse event reporting violations));
- 3 letters re unapproved new devices and new uses (Electrostim Medical Services Inc. dba EMSI, Topcon Corporation and Osmed GmbH (including cGMP violations));
- 3 letters re drug studies (Columbia University Medical Center, Laura A. Teasley, M.D., and Leslie E. Diaz, M.D.);
- 3 letters re medical device reporting (National Therapy Products, Inc. (including cGMP violations), Respironics, Inc., and Laser Eye Care of California, LLC);
- 3 letters re tobacco products (AD and AD International, Ltd., IndoCigs and Vitalie Rotaru);
- 2 letters re mammography standards (Middlesboro Appalachian Regional Hospital and Eiber Radiology, Inc.);
- 2 letters re unapproved new devices (SterilMed, Inc., and OraWell USA (including cGMP violations));
- 1 letter re unapproved dietary supplements (Nordimex, LLC (including cGMP and labeling violations));
- 1 letter re food as unapproved new drug (TCHO Ventures, Inc. (including cGMP violations for food)); and
- 1 letter re postmarketing adverse event reporting (Jazz Pharmaceuticals, Inc.).