FDA EIR - Pharmalogic Puerto Rico Inc - July 22, 2016

An FDA inspection of Lantheus MI Radiopharmaceuticals Inc. in San Juan, PR, was conducted from July 18-22, 2016. This abbreviated inspection, adhering to the Positron Emission Tomography (PET) Current Good Manufacturing Practice (CGMP) Drug Process guidelines (CGMP 7356.002P), identified a critical GMP deficiency. The company was found to have conditionally released PET drug product batches following analytical equipment malfunctions (specifically Gas Chromatograph failures), without documenting reasonable efforts to prevent recurrence of these issues. This practice, observed in November 2015 and March 2016 and contrary to 21 CFR 212.70(f)(1)(iv), allowed product release without assurance that the underlying equipment problems were fully addressed. During management discussions, the firm acknowledged the observation. As corrective actions, Lantheus MI Radiopharmaceuticals Inc. initiated revisions to its standard operating procedure for GC analysis and began a change control process to eliminate the conditional release option, citing its inefficiency and risk. Additionally, while no active pest issues were observed, the inspection highlighted the absence of a formal pest control procedure, which management committed to developing. The company is required to submit a written response to the FDA within fifteen working days, understanding the potential for legal sanctions if compliance is not achieved. The inspection was classified as Voluntary Action Indicated (VAI).