FDA Calls RyMed's Response to Form 483 Unsatisfactory

The FDA told RyMed Technologies during a meeting that the firm's initial response to a Form 483 regarding alleged current good manufacturing practice violations satisfied the agency's concerns, according to the firm. But the FDA nevertheless followed up with a warning letter, the company said.

In the letter, RyMed was cited for failing to ensure that all of its recalled InVision-Plus Neutral IV Connectors were retrieved from the market.

"Your firm failed to ensure that all the affected lots of the referenced devices were effectively retrieved from the market and the users were adequately notified of your firm's recall," the Feb. 9 letter, recently posted to the FDA's website, said.

RyMed initiated a Class III recall for 79,328 IV connectors in May 2006 because of weld failures, which caused the devices to "come apart into pieces." The FDA cited the firm for not submitting a written report detailing the recall, noting that defective connectors presented a "potential risk to health."

The letter can be accessed at www.fda.gov/foi/warning_letters/g6264d.pdf ( http://www.fda.gov/foi/warning_letters/g6264d.pdf ).

( http://www.fdanews.com/ddl/34_14/ )