Failure to control its production processes and to validate them properly landed devicemaker Oscor an FDA warning letter for quality system deficiencies.
The June 13 letter cites the Palm Harbor, Fla.-based company for failing to develop, conduct, control and monitor production processes to ensure devices conform to specifications.
The inspector was critical of the firm’s ethylene oxide (EO) sterilization process for its Maestro rechargeable system, a neuromodulator for obesity, noting that using the single lot release didn’t provide sterility assurance. The firm’s records didn’t identify and record the quantity of samples at the appropriate stage of manufacturing, the letter said.
During the inspection, an employee told the FDA that the firm didn’t maintain a controlled record documenting which device serial numbers are sterilized in each cycle for single batch release.
Sampling Not Representative
“The document provided to our investigator records product samples selected for single lot release testing did not include product samples for [certain lots.] The agency concluded that not all products representing the sterilization lot had been sampled for single lot release, even though the process control records were allocated for single lot release testing.
In addition, process control records didn’t demonstrate that the operating temperature specification was met during the vacuum test phase for a sterilization run. The FDA indicated that the firm’s response to revise the parameters for the operating temperature to ambient would not likely be adequate, particularly since the company didn’t define “ambient temperature.”
The letter notes that the firm’s response that the OEM is directly involved in conducting and documenting EO sterilization processing was inadequate because the firm didn’t provide documentation. Moreover, the firm did not have an explanation for a document provided to the inspector that lacked an approval signature and date.
Process control records were also found lacking for Oscor’s Adelante Magnum catheters because the documents didn’t describe the coating process.
The FDA also cited the firm for failure to validate a process. For example, the firm’s process verification documentation for manufacturing the anterior and posterior leads of the Maestro system did not identify equipment operating parameters.
The agency said the firm “failed to validate or establish sufficient inspections or tests for the silicone injection over-molding process used for the electrodes.” The FDA found the firm’s response inadequate because it didn’t provide supporting documentation identifying equipment operating parameters for the silicone injection over-molding process, the de-flashing process and the inspection process.
Validation activities fell short for the UV curing process for the Adelante Magnum device, the letter said. The firm’s specifications indicated a cure time for the device but didn’t specify appropriate UV intensity to achieve a full cure.
Procedures for in-process and final inspections only required a visual inspection for foreign matter, discoloration or flaky surfaces, and the letter said the procedure lacked adequate physical properties, specifications and testing, such as “adhesion, hardness, thickness, coefficient of friction, to support the quality of the cure.”
Finally, the agency said the firm failed to establish and maintain procedures to control environmental conditions. For example Oscor didn’t monitor environmental conditions such as temperature and humidity in cleanrooms for the Adelante Magnum device.