Satelec Acteon Group hit with 483 and warning letter for process validation, QA deficiencies.

Satelec Acteon Group, Merignac, France, was slapped with a 483 by Claudette Brooks of the Rockville, MD, office and a subsequent warning letter because the firm failed to fully document process validation activities and also because it did not have in place an independent QA unit to perform testing and inspections, according to FDA records.

The September 2003 audit was the first for Satelec Acteon, which makes electronic equipment for dentistry, including ultrasonic scalers, electrosurgical units, electrical dental anesthesia and dental headpieces.

According to the warning letter, the firm "did not establish a validation plan for the sterilization validation activities conducted by the contract sterilizer in 2000 for [unspecified product.]"

The warning letter also stated Satelec Acteon "failed to document the review and evaluation of a process and the revalidation of a process conducted in response to changes or process deviations, as required by 21 CFR 820.75(c)."

For example, "there is no documentation for a current change from the process parameters set at validation. Pressure values have been changed and are different from those established at validation," the warning letter stated.

The firm responded to this citation in writing, but the warning letter stated this was inadequate. "You must provide English translations of the sterilization validation protocols to be used," FDA wrote. "These sterilization validation protocols should include but not be limited to those for the physical qualification of the sterilization equipment; the sub-lethal cycle, and the bacteriologic qualification."

The investigator also pointed out to company quality manager Phillippe Girard that quality assurance did not have responsibility for inspection and testing of materials, components, in-process units or finished devices.

"QA does not review production records, monitor quality defects and has no responsibility for the evaluation or release of devices manufactured at this firm," the EIR stated.

Inspection documents added that Satelec Acteon did perform some inspections and testing. However, employees responsible for the inspections were all production workers who report directly to the production supervisor.

"The QA unit essentially performs audits and is not involved in the routine quality issues or the disposition of manufactured devices," the 483 noted.

The company also was cited because "quality audits were not conducted at sufficient regular intervals, as prescribed by internal procedures to verify that the quality system is effective in fulfilling your quality system objectives," the 483 stated.

The warning letter added that the firm "failed to document corrective and preventive action activities including the actions needed to correct or prevent recurrence of non-conforming product and other quality problems, as required by 21 CFR 820.100(b). For example, there is incomplete documentation of corrective actions necessary for non-conformances noted during quality audits, no documentation of corrective action for administrative complaints and incomplete documentation of corrective action necessary for two technical complaints.

The investigator informed Girard that quality audits that had been scheduled had not taken place, and other scheduled audits, such as for preventative maintenance and for tip manufacturing and instruction manuals, were also not performed in a timely manner.

Girard conceded that the company has identified "a weakness in the audit program in that they do not have enough qualified auditors at the firm," inspection documents noted.

The firm also was cited in the 483 because "corrective and preventive action activities have not been documented, including the actions needed to correct or prevent recurrence of quality problems."

For instance, the 483 noted: "There is a lack of complete documentation of corrective actions necessary for non-conformances noted during quality audits, no documentation of corrective action for administrative complaints and incomplete documentation of corrective action necessary for two technical complaints."

Finally, the investigator noted that Medical Device Reporting (MDR) event files did not reference or contain all adverse event information in the possession of the reporting entity. This included documentation of the deliberations and decision-making process used to determine if an event was reportable or not, the EIR stated.

The warning letter noted that the firm's response was inadequate. "You still have not evaluated the complaint for MDR reportability. This complaint concerned a patient experiencing mouth swelling and discoloration during a procedure using the Prophy mint powder. Additionally, you need to provide an English translation of the revised Customer Complaint Procedure which includes the revised wording concerning 21 CFR 803."

Satelec Acteon Group, Merignac, France, 9/22-25/03, Doc. 109609M, $6.50 plus retrieval.