Advanced Breath Diagnostics Hit With 11-Count Form 483

Advanced Breath Diagnostics was hit with a Form 483 citing 11 observations related to corrective and preventive actions (CAPA), rework and reevaluation activities, acceptance procedures, and other areas.

FDA inspectors visited the company’s Brentwood, Tenn., facility in late August and early September of 2016 and found that procedures for corrective and preventive action were not adequately established. For example, three of seven completed CAPA records reviewed contained no documentation of verification or validation activities used to determine the effectiveness of the actions, investigation requirements were not completed in some cases, and there were no requirements for analyzing quality data from analytical instrumentation to identify causes of nonconforming products. In addition, Advanced Breath failed to document certain corrective and preventive actions.

The Form 483 said rework and reevaluation activities were not documented in a device history record and the company did not implement certain procedures for product acceptance, including in-process leak testing. — Jeff Kinney