FDA EIR - Solara Active Pharma Sciences Limited - April 17, 2017

An FDA inspection was conducted at Strides Shasun Limited's Cuddalore API Site, a manufacturer of non-sterile active pharmaceutical ingredients and intermediate drug products, from April 17-21, 2017. This comprehensive review assessed the facility's adherence to Current Good Manufacturing Practices (CGMP) and pre-approval requirements. The inspection was carried out under regulatory frameworks including Compliance Programs 7352.832 (Pre-Approval Inspections/Methods Validation) and 7356.002F (Bulk Pharmaceutical Chemicals), in conjunction with ICH Q7 Good Manufacturing Practice Guidance for APIs. Key systems evaluated included quality, facility and equipment, materials, production, packaging, labeling, and laboratory controls. A significant outcome of this inspection was the confirmation that the firm had successfully corrected observations from a previous June 2014 inspection. Prior issues had included ineffective product quality review, lack of corrective and preventive action (CAPA) follow-up for complaints, inconsistent adherence to Out-of-Specification (OOS) procedures, and failure to conduct stability studies on reworked API batches. Crucially, the 2017 inspection concluded without issuing any formal FDA-483 Inspectional Observations. Minor discussions with the firm included ensuring smooth surfaces on roughing and scooping tools, for which the company promptly implemented change control actions. Additionally, clarity was established regarding the primary location for specific analytical testing (IC equipment for assay) to be conducted at their formulation site for future quality control release. The inspection affirmed data integrity, commercial readiness, and compliance with drug master files and applications, resulting in a "No Action Indicated" classification.