During a recent FDA inspection of a electronic monitor manufacturer, who used Surface Mount Technology (SMT) for it’s boards, a Senior FDA Investigator brought up an issue concerning the ultrasonic cleaning process validation. This issue was never previously reviewed or even mentioned by any other FDA investigators during inspections of similar operations.

While reviewing the validation of the ultrasonic cleaning operations, this Investigator asked if the validation included a specification for ionic contamination. Though, the cleaner specifications stated it would prevent any ionic contamination, a specification for ionic contamination was never addressed in the validation protocol, nor was ionic contamination validated for.

This was the first time ionic contamination was brought up to this company after 5 FDA inspections. The investigator then proceeded to put this observation on the FDA483. Though, the fact that ionic contamination was not directly addressed, there was never any problems, in-process failures nor repairs that could be contributed to ionic contamination.

When the subject of ionic contamination was brought up to the FDA’s office of compliance or DSMA, they stated that though they were somewhat familiar with what ionic contamination was, they had never saw it on a FDA 483.

The FDA later issued a warning letter because the validation did not include ionic contamination as a specification in cleaning validation. From our investigation the issuance of this warning letter was based solely on this investigator’s recommendation.