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

Source: https://www.keypedia.com/records/warning_letter/kbd-inc/6fc9e6c0-1a47-422f-b59b-17fafbba1417

> FDA WARNING_LETTER for KBD, Inc. on July 25, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: KBD, Inc.
- Inspection Date: 2011-07-25
- Product Type: Devices
- Office Name: Cincinnati District Office
- Summary: 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

## Related Officers

- [District Director](https://www.keypedia.com/people/paul-j-teitell/5de80a65-d370-4a60-8080-21befa356d9b)
- [James Shepherd](https://www.keypedia.com/people/james-shepherd/b5d20dc3-4db8-4429-8061-38e653e25655)

Company: https://www.keypedia.com/companies/kbd-inc/88c658ce-fc82-4f67-89b0-7dc225e2268a

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22