FDA WARNING_LETTER - KHL Inc

On March 17, 2010, the FDA issued a Warning Letter to KHL Inc. following an inspection on July 14, 2009, at their Woodinville, WA facility. The inspection determined that KHL Inc. manufactures gurneys for patient transport to MRI machines, 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 FDA Amendments Act of 2007 (FDAAA), domestic and foreign device establishments must submit this information electronically between October 1st and December 31st each year. KHL Inc. did not complete these requirements between October 1 and December 31, 2008, and as of March 17, 2010, had still not completed the required annual registration.

Consequently, KHL Inc.'s devices are considered misbranded under section 502(o) of the Act because they were manufactured in an unregistered establishment and were not included in a required list. The FDA mandated prompt corrective action to prevent regulatory actions, including seizure, injunction, and/or civil money penalties. Federal agencies are also advised of such Warning Letters, potentially impacting contract awards. KHL Inc. was