FDA EIR - Sharp Packaging Services, LLC - October 25, 2018

An FDA inspection was conducted at Sharp Corporation d/b/a Sharp Packaging Solutions' Conshohocken, PA facility from October 23-25, 2018. The inspection covered a pre-approval assessment for a new drug application (ANDA) and a follow-up on a previously reported Field Alert involving a human drug product. The regulatory framework for this inspection included Compliance Programs 7346.832 (Pre-Approval Inspections) and 7356.021 (Med Watch Reports; NDA Field Alert Reports). No Form FDA-483 (List of Inspectional Observations) was issued during this inspection, indicating no significant deficiencies were identified. The primary issue investigated was a Field Alert Report concerning a packaging defect where rejected blister cards were inadvertently reintroduced into the production line, leading to the distribution of defective units and a subsequent product recall by the customer. The root cause was identified as human or process error related to the handling of rejected materials. To address this, Sharp Packaging Solutions committed to several corrective and preventive actions. These include conducting awareness training for production, quality, and technical staff on equipment operations and the reject process. Furthermore, the company will evaluate its reject process to implement improvements that minimize manual intervention and prevent similar future incidents. Additionally, Sharp is collaborating with the customer to redesign the blister pack and card, ensuring that improper insertion is prevented by design. The pre-approval inspection segment found no deficiencies in the processes for the ANDA product.