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 and documentation of EO sterilization processing of the Maestro rechargeable system and that procedures and production records will be revised. However, the response did not include documentation to this effect. In addition, your firm’s response does not address your firm’s use of the document provided to our investigator that has no signature of an approving individual(s) or the approval date,” according to the letter.
The last violation involved Oscor’s monitoring of the cleanroom where it makes the Adelante Magnum catheter, the agency said.
“For example, your firm does not monitor the environmental conditions, i.e. temperature and humidity conditions, in cleanroom [redacted] where the [redacated] process is conducted for the Adelante Magnum devices,” the FDA said in the letter.
Oscor had 15 business days from the date of the letter of its plans and timetable for addressing the issues flagged in the letter, which the FDA published online July 17.
Sorin Group (now LivaNova (NSDQ:LIVN)) in March 2014 agreed to put $20 million down on Oscor’s cardiac lead manufacturing business as it gears up to develop MRI-safe leads. The deal included a manufacturing plant in the Dominican Republic, all of the Oscor-branded and OEM leads Oscor already makes for Sorin’s bradycardia devices, and the design files and “development resources” for an MRI-safe lead project.