FDA warns Oscor on process control records

The FDA last month warned contract manufacturer Oscor on its methods for documenting process controls for the catheters and neurostimulation leads it makes, after inspections in February and March turned up a trio of violations. The federal safety watchdog said it inspected Oscor’s plant in Palm Harbor, Fla., where it makes the Adelante Magnum introducer catheter and lead components for the Maestro neurostimulation device for treating obesity made by EnteroMedics (NSDQ:ETRM). The warning letter came after Oscor’s April 6 response to the Form 483 observations issued after the inspection. That reply wasn’t adequate, according to the FDA. Oscor failed to validate the process for making Maestro’s anterior and posterior leads “to ensure that the process can consistently produce products meeting their specification,” the FDA said, citing “your customer complaint indicating silicone flash/residue was found on the electrodes of the anterior and posterior leads and is associated with non-conformances of high impedance and loss of therapy from use of the Maestro rechargeable system,” despite a 100% inspection policy. The FDA also flagged Oscor for the way it documents single lot release sterilization using ethylene oxide, according to the June 13 warning letter. “FDA considers EO sterilization processing of medical devices a significant risk process. Your firm’s response indicates the OEM is directly involved in the conduct ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Catheters Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Regulatory/Compliance EnteroMedics Inc. Oscor Source Type: news