FDA WARNING_LETTER - Behavioral Therapeutics, LLC. - December 18, 2007

The FDA issued a Warning Letter to Connecticut Educational Services (CES) and Behavioral Therapeutics, LLC, regarding their "Good Vibrations" device, following inspections in October and December 2007. The device is deemed adulterated because it lacks an approved premarket approval (PMA) or investigational device exemption (IDE), and misbranded due to failure to submit a 510(k) premarket notification.

Furthermore, the device is adulterated under CGMP requirements (21 CFR Part 820) due to numerous Quality System (QS) violations. These include: 1. **Failure to control design:** No procedures for design control, and undocumented changes to the device (e.g., reset button, software revisions, voltage reduction). No Design History File (DHF) maintained. 2. **Failure to maintain Device Master Records (DMRs):** No DMRs including specifications for device, production, quality assurance, packaging/labeling, or installation/maintenance. 3. **Failure to implement corrective and preventive actions (CAPA):** No CAPA procedures for analyzing quality problems, investigating non-conformities, identifying corrective actions, verifying effectiveness, or documenting activities. 4. **Failure to handle complaints:** No procedures for receiving, reviewing, or evaluating complaints, including timely processing, documentation of oral complaints, investigation, or reporting of adverse events. 5. **Failure to control rework:** No procedures