FDA EIR - Alcami Carolinas Corporation - December 06, 2024

An FDA comprehensive surveillance inspection of Alcami Carolinas Corporation, located at 419 Davis Drive, Morrisville, NC, was conducted from December 02 to December 06, 2024. This unannounced, high-priority inspection focused on data integrity and analytical processes, specifically method validation and sample analysis activities related to an Abbreviated New Drug Application (ANDA). The inspection adhered to Compliance Program 7348.004.

During the inspection, FDA personnel reviewed extensive documentation, including study records, method validation and sample analysis data, instrument calibration logs, standard operating procedures, and personnel training records. They also toured relevant areas of the facility, observed dissolution testing, and interviewed analysts.

Significantly, the inspection concluded without any observations of objectionable conditions or practices. The FDA inspector did not issue a Form FDA 483, which indicates findings that may constitute violations. Consequently, the final district decision was "No Action Indicated" (NAI), signifying that Alcami Carolinas Corporation was found to be in compliance with applicable regulatory requirements. As a result, no specific regulatory violations were cited, and no immediate corrective actions were required from the company.