Zeller Power Products, LLC – FDA Warning Letter, Nov 9, 2018

The FDA issued a Warning Letter to Zeller Power Products, LLC, following a November 6-9, 2018 inspection of their Las Vegas, NV facility. The firm manufactures Class III Automated External Defibrillator (AED) Batteries, which are considered adulterated due to non-conformity with Quality System Regulation (21 CFR Part 820) and misbranded under sections 502(c) and 502(t)(2) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to validate design (21 CFR 820.30(g))**: No documentation for battery shelf-life, operational guarantee, or shock capacity. Software for battery compatibility with defibrillators was also not validated. This is a repeat observation. 2. **Failure to establish design control procedures (21 CFR 820.30(a))**: No documented procedures for design plan, inputs, validation, reviews, or risk analysis. This is a repeat observation. 3. **Failure to establish complaint handling procedures (21 CFR 820.198(a))**: No formal procedures for receiving, reviewing, or evaluating complaints, including MDR reporting. Returned Goods Authorizations (RGAs) were not documented as complaints. This is a repeat observation. 4. **Failure to establish acceptance activity procedures (21 CFR 820.