Vintage Labs cited for inadequate investigation of microbiological contamination
This article was originally published in The Gold Sheet
Executive Summary
Generic drug maker Vintage Pharmaceuticals of Huntsville, Ala., received a Feb. 1 warning letter from FDA for not adequately investigating evidence of microbiological contamination and failure to maintain a complete record of data in the course of each test, as well as failing to follow appropriate written procedures designed to prevent objectionable microorganisms in drug product. The letter stated that "the inspection initially found your firm had over 13 months of environmental monitoring data. There was no record showing isolates obtained from air samples were being identified; and, during the inspection, our investigators were told there was no record of environmental trending data.