FDA has hit Rechargeable Power Energy (RPE) and Zeller Power Products with warning letters for repeat quality failings in the production of external defibrillator batteries.
The letters appear to address repeated issues from 2016 that found RPE and Zeller noncompliant with good manufacturing practices, putting them at risk of losing market access.
FDA released the warning letters within days of a separate letter issued to Orchid Orthopedic Solutions, which inspectors chided for manufacturing quality failings at its orthopaedic implant coating facility.
FDA hit Rechargeable Power Energy and Zeller Power Products with warning letters over quality issues related to defibrillators in letters posted to the agency's website this week.
Both warning letters cover inspections of the same site in Las Vegas that took place on the same days in November. And both letters refer repeatedly to FDA inspectors finding the same failings during inspections dated Jan. 20-22, 2016, and there are sections of the regulatory notices that are nearly identical.
In the warning letter to RPE, FDA faults the company for its lack of complaint-handling procedures. FDA said the company’s customer — which it does not identify — handles all complaints unless an investigation is required. The customer typically resolves the complaints with a phone call explaining how to properly install the battery. RPE only gets involved if an investigation is required, the letter said.
In the Zeller warning letter, FDA states that the company handles most complaints, typically through phone calls to explain how to install the battery. The exceptions are complaints that require an investigation. In those cases, Zeller transfers the case to an unnamed third party.
That observation, like many made across the two warning letters, is a repeat of an issue FDA found when it inspected the companies in 2016, meaning the companies would have known about the problems for almost two years at the time of the November assessment. But FDA deemed the company responses to the second inspection to be inadequate.
In the case of the complaints-handling observation, FDA again ruled RPE and Zeller’s responses inadequate due to factors including the lack of evidence showing they had conducted a retrospective review of the problems inspectors identified.
FDA’s warning letter to Orchid also outlines problems with the complaint handling, plus criticisms of control procedures, process validation and quality audits. Specific problems identified by FDA include the failure to document the reworking of nonconforming products, for example, when voids in the seal need addressing.