FDA EIR - Zoll Manufacturing Corp. - November 18, 2010

Zoll Lifecor, a manufacturer of wearable automated external defibrillators (LifeVest), underwent a Pre-Approval FDA inspection on November 18, 2010. This inspection, conducted at their new manufacturing site at 121 Gamma Drive in Pittsburgh, PA, was a crucial part of the review for PMA supplement P010030/S21. The supplement pertained to the company's planned phased relocation of production facilities from their existing Freeport Road location to the new Gamma Drive site.

The inspection focused on assessing the firm's readiness to initiate production at the new facility. Investigators verified the consistency of production equipment and associated instrumentation with the information provided in the site change supplement. They also reviewed validation activities for selected processes, particularly those involving new equipment for therapy electrode manufacturing. The inspection confirmed that the new site operates under the same established quality system, management, and ownership as the previous facility, with full access to controlled documentation via a VPN network.

Crucially, the FDA inspection found no deficiencies related to process readiness, validation issues, or discrepancies in the data presented in the site change supplement. As a result, no FDA 483 was issued, indicating no objectionable conditions requiring corrective actions were identified. The inspection concluded without adverse findings, affirming Zoll Lifecor's preparedness for the relocation.