FDA EIR - SGS Chemical Solutions Laboratories Inc. - August 22, 2018

An FDA Pre-Approval Inspection of Chemical Solutions Ltd. in Harrisburg, PA, was conducted from August 20-22, 2018. This inspection, carried out under CP 7346.832 for an ANDA application, focused on the company's readiness for commercial manufacturing, conformance to applications, and data integrity concerning drug substance and product elemental impurity testing. The inspection identified two main violations. A repeat observation cited the firm for inadequate controls over computerized systems (21 CFR 211.68(b)), specifically noting that analysts held administrative privileges, enabling them to delete or alter electronic raw data without these changes being reflected in the system's audit trail. The second violation concerned deficient laboratory records (21 CFR 211.194(a)(1)), as the firm lacked complete documentation for the quantity of non-controlled drug product samples received, the amounts removed for testing, and the proper recording of discarded samples. While some deficiencies from a previous 2015 inspection regarding out-of-specification investigations and control of log sheets had been voluntarily corrected, the data integrity and sample record-keeping issues persisted. Management acknowledged the findings and committed to implementing corrective actions, with a formal written response required for the issued two-item Form FDA-483.