Integra Chemical Company Renton, WA (6/13). Inspected 5/16-21/02. GMP deviations, adulterated: The room used for repackaging APIs is not maintained in a clean and sanitary condition nor is it of suitable construction in that the ceiling tiles are porous, damaged ceiling tiling have been replaced with cardboard, and the floor is cracked and in need of repair. There is inadequate ventilation of the repackaging room in that a window fan is used for ventilation to the adjacent warehouse area and cardboard is used to seal the window frame in which the fan is installed. Firm failed to retain a reserve sample representative of each lot of API repackaged, etc. (Repackaged active pharmaceutical ingredients); FDCA 501(a)(2)(B), 21CFR 211.42(a), 211.56(a), 211.46(a), 211.142(b), 211.170(a), 211.198, 211.204. (SEA 02-49)
