FDA WARNING_LETTER - Nanotherapeutics, Inc - September 07, 2010

On February 22, 2011, the FDA issued a Warning Letter to Nanotherapeutics, Inc. following an inspection from August 30 to September 7, 2010. The firm manufactures Origen® DBM/NanoFUSE® DBM with Bioactive Glass, classified as a device.

The device is adulterated because the firm lacks an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) application. It is also misbranded as a significant modification (adding an undisclosed substance to increase gelatin melt temperature) was made without submitting a new 510(k) notice, which is required as it could affect safety or effectiveness.

Furthermore, the devices are adulterated under 21 CFR Part 820 (Quality System Regulation) due to multiple CGMP violations. These include: 1. Failure to review and revalidate processes for changes (e.g., DBM drying time, gelatin cooling modifications), lacking proper documentation and justification. 2. Failure to establish and maintain procedures for design change control, with observed changes (e.g., substance addition, DBM raw material, packaging size) lacking proper review, approval, and stability studies. 3. Failure to verify or validate corrective and preventive actions (CAPAs) for effectiveness (e.g., CAPA #08-002 for nonconforming packaging lacked feedback into the system).