FDA EIR - Renaissance Lakewood, LLC - May 24, 2023

An FDA surveillance inspection of Renaissance Lakewood, LLC, a contract manufacturer of sterile and non-sterile prescription drugs in Lakewood, NJ, was conducted from May 24 to June 06, 2023. The inspection sought to ensure compliance with Current Good Manufacturing Practices (CGMP) for drug manufacturing, specifically covering sterile drug processes.

The recent inspection revealed several significant issues, leading to a four-point FDA Form 483, Inspectional Observations. Noteworthy violations included inadequate maintenance of the stability chamber, a detected leak in the pre-generation closed-loop water system, insufficient accountability and improper storage of stability samples, and a failure to perform performance qualification for equipment used in drug manufacturing. Discussions also highlighted concerns regarding incomplete documentation for equipment, batch records, process justifications, and deficiencies in aseptic gowning procedures, microorganism identification, and monitoring of water systems and reference standards.

Firm management acknowledged these observations and committed to initiating corrective actions, promising a written response within 15 business days. The inspection was classified as "Voluntary Action Indicated" (VAI), meaning the firm is expected to take action, and a reinspection is planned to verify compliance.