FDA WARNING_LETTER - Valor Medical Inc - December 15, 2010

The FDA issued a Warning Letter to Valor Medical, Inc. on March 24, 2011, following an inspection from December 14-15, 2010. The inspection, conducted by the FDA Los Angeles and Chicago District Offices, aimed to assess compliance with federal regulations for Investigational Device Exemption (IDE) (b)(4) for the (b)(4) device.

The FDA found serious violations of 21 CFR Part 812 – Investigational Device Exemptions, and Section 520(g) (21 USC 360j(g)) of the Federal Food, Drug, and Cosmetic Act. This renders the (b)(4) device adulterated under section 501(i) of the Act.

Specifically, Valor Medical, Inc. failed to include reports of all prior clinical, animal, and laboratory testing of the device, violating 21 CFR 812.27(a). The company did not submit two required animal study reports: "(b)(4) Assay" and "(b)(4) Assay."

Valor Medical, Inc. must provide written documentation of corrective actions within fifteen working days, including projected completion dates. Failure to respond or take appropriate action may result in further regulatory action. The response should reference "CTS # (b)(4) /E001" and be sent to the Center for Devices and Radiological Health, Office