An FDA inspection netted Zeller Power Products (Wallace, Idaho) a warning letter citing quality violations that led to adulterated defibrillator batteries.
Specifically, the agency discovered during its Nov. 6-9, 2018 inspection of that the firm didn’t have design validation documentation for its automated external defibrillator battery. The design validation documentation was needed to justify the battery’s five-year shelf-life. The company also failed to validate software used on the battery’s circuit boards, according to the agency.
The warning letter repeated observations from a 2016 inspection and added that the company has been selling its AED batteries without premarket approval (PMA). The agency said Zeller can continue to sell the batteries without a PMA until February 2020.
The warning letter can be found here. The company did not immediately respond to a request for comment.
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