FDA EIR - PharmaLogic Colorado LLC - November 12, 2021

An FDA comprehensive surveillance and pre-approval inspection was conducted at PharmaLogic Colorado LLC from November 8 to November 12, 2021. This initial inspection aimed to evaluate the facility's readiness to manufacture Positron Emission Tomography (PET) drugs, specifically Fludeoxyglucose F-18 injection, USP, and Ammonia N-13 injection, USP, for existing Abbreviated New Drug Applications (ANDAs) held by Precision Nuclear LLC. The inspection followed CPG 7356.002P, focusing on CGMP compliance for PET drug manufacturing. No Form FDA 483 (Inspectional Observations) was issued, indicating the facility's overall capability to produce PET drugs in accordance with Current Good Manufacturing Practices and that submitted application data appeared reliable. However, two discussion items were raised: a need for greater detail in Standard Operating Procedures (SOPs) regarding various operational aspects, and the presence of acoustic ceiling tiles in the component storage area, which presented a cleaning challenge. The company acknowledged these points and was actively addressing them, including revising SOPs and planning to replace the acoustic tiles. Management was reminded of their responsibility to voluntarily correct any conditions to prevent potential regulatory sanctions.