With the consent decree, the risk of financial death is very real.
A twist on the classic holiday song, complete with FDA condemnation.
FDA recently ordered a manufacturer of automated endoscope reprocessors to recall product following a consent decree from 2007.
There is no such thing as minimum or maximum compliance—there is just compliance.
Medtronic repeatedly fails to correct manufacturing violations related to its Synchromed II Implantable Infusion Pump Systems.
Consent decrees are expensive. Remember, consent decree and the resulting actions are driven by the courts and all bets are off in regards to when normal business operations will return, if ever. If the process of paying the third-party consultants does not grab the attention of the controller, rest assured the fines levied by the courts should. One final thought, with no new product approvals from FDA on the horizon, your competitors will be thanking you as your customer base and market share quickly be…