A litany of quality management lapses landed contract manufacturer Rechargeable Power Energy North America a warning letter following a Nov. 5-9, 2018 FDA inspection of its Las Vegas, Nevada facility.
The company is a contract manufacturer that makes Class III automated external defibrillator (AED) batteries that replace original equipment manufacturer batteries.
FDA investigators found that the firm’s battery testing and calibration equipment was not validated to demonstrate that results were repeatable for every battery tested. The firm said in its response to the agency’s Form 483 inspection report that an independent review would be conducted, and a test would be performed to validate the battery’s shelf life.
However, the FDA said the company should provide plans to ensure that its production equipment and software are validated, noting that this was a repeat observation from a January 2016 inspection.