FDA Takes Aim at Two Integra Units in Form 483s

Integra subsidiary Theken Spine was handed a Form 483 for failure to submit 11 of 35 complaints involving products made at its Akron, Ohio, facility. Another five complaints were not submitted within the required 30 day time frame, and 14 complaints associated with corrective actions were never reported to the FDA. Moreover, corrective and preventive action activities and results, including changes to overcome adverse events, were not fully documented, the FDA’s Cincinnati District Office found. The majority of medical device reports involved defective surgical screws.
The GMP Letter