Primera Analytical Solutions Corp. – FDA EIR, Jan 23, 2017

An FDA inspection of Primera Analytical Solutions Corp., a control testing laboratory in Princeton, NJ, was conducted from January 17 to January 23, 2017. The inspection, part of the New Jersey District FY2017 Drug Work plan, focused on Good Manufacturing Practices (GMP) related to drug manufacturing and post-approval monitoring of animal drugs. The previous inspection in 2015 had no significant deficiencies.

However, the current surveillance inspection resulted in an FDA-483 form with significant observations. The primary issues included inadequate written procedures for handling electronic records, specifically regarding data backup, restoration, user access, security, audit trail verification, and reporting of analytical test results. Additionally, employee training on record-keeping requirements, particularly for electronic data control, was found to be insufficient. A verbal observation also noted that the suitability of one analytical method had not been adequately established.

In response, Primera Analytical Solutions Corp. acknowledged the observations and committed to corrective actions. These actions included revising and implementing new standard operating procedures to enhance electronic data management, backup, and archive processes. The company also agreed to provide comprehensive training to its employees and IT consultant on electronic data controls to ensure data integrity and compliance with regulatory expectations.