FDA seeks $2.2 mln fine against Advanced Bionics

[flashl]

Source: Reuters

WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Friday it wants to fine Advanced Bionics LLC, a maker of cochlear implant hearing aids, $2.2 million for alleged manufacturing violations that put patients at risk.

The FDA accused Advanced Bionics of failing to follow manufacturing standards to ensure the safety and quality of the hearing aids.

The company allegedly failed to sufficiently evaluate and select a new vendor to supply a critical component, and failed to properly test hearing aids containing the unapproved vendor's component, the FDA said in a statement.

"The hearing aids pose a public health risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss," the FDA said in a statement.

Reuters

Read more: http://www.reuters.com/article/rbssHealthcareNews/idUSN2834058620080328

[cspanlovr]

1. But, but,,,we have the best health care in the WORLD!

How pathetic is this?

[Stargazer99]

2. It surprises the hell outa me that the FDA finally got off their arse

and decided to protect the citizen instead of big business...what they were established to do