Northland Nuclear Medicine, LLC – FDA EIR, Jun 7, 2019

Northland Nuclear Medicine, LLC (NNM) underwent its initial FDA pre-approval inspection from June 3 to June 7, 2019, regarding its manufacturing of Positron Emission Tomography (PET) pharmaceutical drugs. The inspection, conducted under Compliance Guide 7352.832 (P) for ANDA 203994-Supplement-02, identified significant quality system deficiencies, resulting in a 3-Observation FDA-483. Key violations centered on inadequate production and process controls, including insufficient aseptic process simulations that failed to emulate worst-case conditions or independent assessments. Critical electronic spreadsheets used for calculations like radionuclide half-life and patient dosing lacked proper validation for accuracy and data integrity. The firm also had pending procedures for vendor and material qualification, crucial for ensuring the quality of incoming components.

Further issues included the absence of installation, operational, and performance qualifications (IQ/OQ/PQ) for essential equipment such as the (b)(4) and the Gas Chromatograph used for residual solvent analysis. Master production and control records were found to be incomplete, failing to document all necessary steps in the PET drug production process, specifically omitting critical aseptic transfer procedures and misrepresenting vial introduction sequences. NNM acknowledged the observations and committed to providing a written response with corrective actions. However, the FDA's assessment concluded that NNM had not met the pre-approval objectives, leading to a recommendation for a 'withhold' on the ANDA until these issues are resolved.