Date: 08 April 2010
Link: FDA Warning Letter (New Window)
Observation7. Your firm failed to routinely calibrate, inspect, or check automatic, mechanical, or electronic equipment according to a written program designed to assure proper performance [21 C.F.R. § 211.68(a)].
For example, your firm has not conducted performance qualification for the (b)(4) unit-dose packaging machine (b)(4)™ to
Tuesday, 18 May 2010
CSV FDA Warning Letters : Qualification
Posted on 11:10 by Unknown
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