Ambco Warned Over CAPAs Following FDA, DPH Inspections

October 29, 2014

The FDA has warned Ambco Electronics after the devicemaker failed to correct deficiencies noted during a California Department of Public Health inspection and an earlier FDA inspection.

Ambco, which makes audiometers, received a violations notice from the health department on May 17, 2008, and an FDA Form 483 on Dec. 10 of that year, according to the Sept. 26 letter posted recently online. The company initiated two corrective and preventive actions to address the deficiencies, and a July 8-27, 2014, FDA inspection found the status of those CAPAs listed as completed.

But the Tustin, Calif., company lacked documentation of the corrections, and “our current inspection found many previous deficiencies were not corrected,” the letter says. Identified in the latest inspection were issues with receiving inspection procedures, component identification and traceability, acceptance activities, CAPA activities, trending and analysis of data sources, device history records and employee training.

Further, the company failed to properly implement its CAPA procedure, the FDA notes. The procedure requires investigations of devices reported or returned from the field as defective or malfunctioning, but Ambco hadn’t documented a review of potential trends or a trending analysis of customer experience reports, as required.

Ambco’s customer experience reports also failed to include details and data on the investigations and tests the company performed.

Vendor qualification also came under the microscope, as Ambco had neither implemented its qualification procedure nor defined and documented the specifications that component suppliers must meet.

“Your firm has not performed audits of custom device components, such as the keypad membrane and the firmware, and there is no ISO registration for those firms on file,” the warning letter says. The FDA will assess Ambco’s corrective actions in a follow-up inspection.

In addition to these issues, the investigator, from the FDA’s Los Angeles district office found that while Ambco routinely calibrates its devices, its standard operating procedure lacks specific instructions for calibration. The company also did not always complete a form required for these procedures.

The finished device acceptance testing and calibration procedure for one audiometer model failed to include specific instructions, as well as accuracy and precision limits, and it did not identify acceptable results, the letter says.

Meanwhile, Ambco’s device history records don’t include the complete acceptance records and primary identification label for each production unit, and the company could not provide appropriate personnel training records at the time of the inspection.