Stryker Neurovascular drew a Form 483 for failing to maintain complaint files and failing to file medical device reports, among other violations.
The Fremont, California medical device facility was found in an October inspection to have neglected procedures to ensure all complaints were processed efficiently, with more than half of the reviewed complaints exceeding the targeted time of completion.
The FDA also found that the firm had not established process control procedures listing all process controls necessary for conformance to specifications. The facility failed to follow a manufacturing environment procedure when it passed material from a warehouse to a Class 8 clean room and failed to wipe down the entire exterior surface of the material.
The facility also failed to submit four MDR reports within 30 days of receiving or becoming aware of information suggesting one of their marketed products may have caused or contributed to an injury or death, or had malfunctioned and would be likely to cause or contribute to an adverse event if there was another malfunction.