Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics finds itself in the FDA spotlight, according to a warning letter released by the agency’s Centers for Devices & Radiological Health this week.
The watchdog agency detailed more than a dozen devices or device components it said lacked proper PMA clearance or which were modified in ways that merit a new 510(k) application.
DePuy distributed the devices without seeking additional approval, believing the products to be exempt because they qualify as custom devices, according to the warning letter, filed by Steven Silverman of the CDRH’s office of compliance.
"The fact that the final specifications are tailored to match a patient’s anatomy does not preclude a clinical study or submission of a marketing application for the devices," Silverman wrote.
The agency urged the Warsaw, Indiana-based device maker to act swiftly to address the issues, or face penalties such as possible fines, seizure and injunction.
The inspection took place from May 10, 2011, to June 7, 2011, and also noted several quality issues, including inadequate complaint review procedures and inadequate procedures to ensure devices conform to a user’s needs, according to the letter.
J&J received another warning recently for failing to report incidents where its OneTouch Ping and 2020 insulin pumps may have caused death or serious injury.
In an inspection of the West Chester, Pa.-based plant, the federal watchdog agency found that J&J’s Animas Corp. never reported on 1 complaint about series patient injury and delayed reporting 2 other incidents to the FDA.