Warning Letter
FDA: Warning letters hit 5-year low in 2013
FDA orders iRadimed to submit new 510(k) after site inspection, stock tanks
FDA warns Vention Medical on Costa Rica plant
The FDA last month slapped Vention Medical with a warning letter over conditions at a plant in Costa Rica, flagging problems with the medical device company’s procedures there.
The July 1 letter was prompted by an FDA inspection in March of a plant in Barreal de Heredia, Costa Rica, the FDA said.
St. Jude Medical says FDA clears Texas neuromodulation plant
Masimo reveals FDA warning letter over Pronto 7 monitor
UPDATE: FDA warns CareFusion over modified devices, quality control
FDA dings Spinal Elements for design changes, unreviewed claims
The FDA posted a warning letter against California-based Spinal Elements, saying that the company failed to obtain regulatory clearance for design changes to certain of its intervertebral body fusion devices.
FDA chides Philips Respironics over infant sleep monitor manufacturing
Philips Healthcare’s (NYSE:PHG) Respironics unit is in the FDA’s cross-hairs after regulators inspected a manufacturing facility responsible for infant sleep apnea monitors that were the subject of a recall.