Vulcon Technologies Inc – FDA Warning Letter, Jul 6, 2009

On March 17, 2010, the FDA issued a Warning Letter to Vulcon Technologies Inc. following an inspection from July 1-6, 2009, at their Grandview, MO facility. The inspection determined that Vulcon Technologies manufactures hematocrit measuring centrifuges, which are classified as medical devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

The primary violation identified was the firm's failure to fulfill annual establishment registration and device listing requirements. Under section 510 of the Act, as amended by the FDAAA in September 2007, domestic and foreign device establishments are required to submit this information electronically between October 1 and December 31 each year. FDA records indicated that Vulcon Technologies did not complete these requirements between October 1 and December 31, 2008, and as of March 17, 2010, the registration remained incomplete.

This non-compliance renders the firm's devices misbranded under section 502(o) of the Act, as they were manufactured in an unregistered establishment and not included in a required list. The FDA mandated prompt corrective action to address this violation. Failure to comply could result in regulatory actions including seizure, injunction, and/or civil money penalties. Federal agencies are also informed of such Warning Letters, which may impact contract awards.

Vulcon Technologies