FDA Warns NeoChild for Misbranded Devices

NeoChild’s alleged misbranding of its neonatal devices and failure to establish written procedures for numerous good manufacturing practice (GMP) requirements drew an FDA warning letter.

The FDA cited the firm for marketing its SafeChild System’s enteral feeding tubes and extension sets before filing a PMA or getting 510(k) clearance. Also, the silicone and polyurethane enteral feeding tubes and the PVC extension sets were not approved for an investigational device exemption, the July 29 letter says.

The agency told NeoChild to submit a PMA so it can evaluate the information and decide whether the products may be legally marketed.

NeoChild also was cited for failure to develop or implement written medical device report (MDR) procedures from the time it started distributing devices in March 2007 to the date of inspection in April. The company provided the FDA with a copy of its new MDR procedures in its May 15 response.

During its inspection, the FDA noted 10 GMP violations in which the firm’s device designs for its enteral feeding tubes, extension sets and pediatric urinary drainage catheters did not meet quality standards.

NeoChild responded to each violation by providing the title of its appropriate standard operating procedure. The FDA says that response is inadequate because the firm did not provide the complete documents with specifics or full explanations of all procedures.