Failure to validate the design of its AED batteries, lax complaint handling procedures and numerous other quality system repeat observations resulted in a warning letter for AED maker Zeller Power Products following a Nov. 6-9, 2018 inspection of its Wallace, Idaho facility. The FDA said the firm’s response to the Form 483 was not acceptable.
Zeller makes Class III AED batteries to replace OEM batteries used in Cardiac Science PowerHeart AEDs.
During the FDA inspection, Zeller was unable to provide documentation validating the shelf life of its batteries as well as the number of shocks as indicated by the device specifications. The firm’s management told FDA inspectors that the software installed on the printed circuit board included in each battery were not validated.
The management also told inspectors that the firm had not established design control procedures and was unable to provide documentation of design plans, design inputs, design validation, design reviews or risk analysis.
Procedures for reviewing complaints as well as CAPA procedures had not been established, nor had Zeller established procedures for accepting incoming products. It also had not established procedures to control product that doesn’t conform to specifications.
All of these were repeat observations from a previous inspection. The FDA also cited the firm for failing to ensure that labeling met UDI requirements.
Read the warning letter here: www.fdanews.com/05-23-19-ZellerPowerProductsWL.pdf.