Date: 21 December 2009
Link: FDA Warning Letter (New Window)
Observation19. Automatic, mechanical, or electronic equipment is not routinely calibrated, inspected, or checked according to a written program designed to assure proper performance [21 CFR 211.68(a)]. For instance, the mixer, scales, filling/dispensing machine, water distiller, foil heat sealing machine, drying chamber, and tablet
Monday, 24 May 2010
CSV FDA Warning Letters : Operational Compliance
Posted on 11:11 by Unknown
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