FDA EIR - Altasciences CDMO Philadelphia, LLC - March 16, 2011

An FDA Pre-Approval and Good Manufacturing Practice (GMP) inspection was conducted at Alliance Contract Pharma, LLC in Harleysville, PA, from March 14 to March 16, 2011. This inspection evaluated the facility as a contract manufacturer and testing facility, specifically focusing on the capsule banding process for an Abbreviated New Drug Application (ANDA). The regulatory oversight for this inspection followed established FDA procedures for pre-approval and drug manufacturing assessments. During the inspection, no significant deficiencies were identified, and no formal Form FDA 483 was issued. However, two discussion items were raised with company management. Firstly, blue residue from the banding solution was observed on equipment, and there was a lack of annual microbiological sampling to ensure cleaning efficacy and prevent microbial growth. Secondly, carpets were noted in areas adjacent to critical cGMP (current Good Manufacturing Practice) suites. Alliance Contract Pharma's management provided assurances that corrective actions would be implemented for both observations. The FDA investigator concluded the inspection by recommending approval for the specific banding process reviewed at this site, noting that final overall application approval would come from the Center for Drug Evaluation and Research (CDER).