FDANews reported in a recent article that 15 new warning letters were issued to device manufacturers for GMP violations. One letter was issued to a U.S. company with the remaining 14 issued for foreign manufacturers. The warning letters were issued after FDA investigators conducted inspections of the manufacturing facilities and found violations. FDA states that manufacturers should correct violations promptly and failure to correct may result in legal action.
If you need help with device manufacturing challenges, Pearl Pathways can help you achieve quality compliance in your manufacturing. Contact us and we can make a plan together.