FDA WARNING_LETTER - KBD, Inc. - July 25, 2011

On December 15, 2011, the FDA issued a Warning Letter to KBD, Inc. following an inspection from July 5-25, 2011, which found their sunlamps and phototherapy lamps to be adulterated under 21 U.S.C. 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's August 3, 2011, response to the FDA 483 was deemed inadequate.

Key violations include: - **Corrective and Preventive Actions (CAPA):** Failure to establish procedures for analyzing quality data, investigating nonconformities, identifying/verifying/implementing corrective actions, and disseminating information (21 CFR 820.100(a)). - **Design Control:** Inadequate procedures for design control, including lack of information on design and development plans, input, output, review, verification, validation, risk analysis, and transfer (21 CFR 820.30). - **Design Input:** Failure to establish, review, approve, and document design inputs for the KBD Vitamin D Sunlamp, including intended use, performance requirements, and user needs (21 CFR 820.30(c)). - **Design Validation & Risk Analysis:** Inadequate validation to ensure devices conform to user needs