MEDTRONIC VIOLATED CGMPS IN MAKING INFUSION PUMPS, FDA SAYS
Medtronic's neurological division was cited for a slew of current good manufacturing practice (cGMP) violations in an Aug. 29 FDA warning letter. The letter was posted to the agency's website Sept. 12.
The warning letter came after an inspection between May 18 and June 22 at Medtronic Neurological in Minneapolis. The firm makes implantable drug infusion and neurostimulation products to treat pain, movement disorders and other medical conditions, the FDA noted.
Among the "significant" deviations to federal regulations, the letter said the firm failed to ensure that a device's design input requirements were appropriate.
Also, the tip bonding process for one catheter was not validated, and production processes were not controlled to ensure that a device conformed to its specifications, the letter said.