FDA EIR - Alcami Carolinas Corporation - February 21, 2019

An FDA Pre-Approval Inspection (PAI) was conducted at Alcami Carolinas Corporation in Charleston, SC, from February 18-21, 2019. This inspection, initiated by the Center for Drug Evaluation and Research, focused on assessing the facility's readiness for commercial manufacturing of a new sterile injectable product and its conformance to the filed application. It was explicitly a PAI, not a routine Current Good Manufacturing Practices (cGMP) inspection.

While no formal Form FDA 483, Inspectional Observations, was issued, inspectors verbally communicated five key observations to management. These included an insufficient investigation into a deviation concerning sample shipping, a lack of documented assurance that cleanroom personnel had corrected previously noted rapid movement, and inadequate time documentation for handling the active pharmaceutical ingredient (API), along with concerns regarding rusted and dented secondary API containers. Other issues involved untimely Good Documentation Practice (GDP) markings in batch records, made months after manufacturing, and significant overcrowding in storage areas, including fridges, freezers, hold, and quarantine.

The FDA team recommended approval for the application product but reminded Alcami of its responsibility to adhere to cGMP. The verbal observations highlight areas where Alcami is expected to implement improvements to ensure compliant and controlled manufacturing operations.