Device Companies Had Thousands of Open Complaints, FDA Says

Failure to adhere to current good manufacturing standards continues to be a problem for medical device manufacturers, according to the latest batch of warning letters posted to the FDA’s website May 2.

Unetixs Vascular Inc. and Criticare Technologies Inc. were cited for not investigating thousands of complaints, while Organ Recovery Systems Inc.'s manufacturing issues included inadequately ensuring the safe shipment of bags containing organ preservation solution.

Warning letters are a good indication of the FDA’s enforcement priorities. The FDA frequently cites companies for violations of current good manufacturing practices (cGMP), with inadequate complaint handling a top category.