FDA 483 - Pharmaron (Ningbo) Technology Development Co. Ltd. - November 01, 2024

An FDA inspection conducted at Pharmaron (Ningbo) Technology Development Co. Ltd. from October 28 to November 1, 2024, resulted in the issuance of a Form 483, detailing significant observations related to manufacturing controls. The primary issues identified involve deficiencies in laboratory controls, environmental monitoring, and raw material sampling procedures. Specifically, the inspection revealed that the company did not perform required growth promotion testing on microbiological media used for finished API product testing, stability samples, and microbiology limit test method validation. Furthermore, environmental monitoring in Grade D API processing areas was found inadequate, with monitoring for particulate matter and microbial organisms primarily conducted under static, rather than dynamic, conditions. The FDA also noted a lack of detailed written procedures for the random and representative sampling of raw materials and components, resulting in sampling practices that were not representative of received lots. These observations signify potential deviations from regulatory expectations for pharmaceutical manufacturing. Pharmaron (Ningbo) Technology Development Co. Ltd. is required to thoroughly investigate these findings, develop and implement comprehensive corrective and preventive actions, and formally respond to the FDA to demonstrate their plan for achieving and maintaining compliance.