Searle hit for OOS in multiple
Selected Abstract
Searle hit for OOS in multiple validation lots. (Human Drugs).
A Dec. 27, 2002, warning letter cited Searle's Barceloneta, PR, facility for inadequate in-process controls in that during the validation of the manufacturing process for Plaquenil 200 mg tablets, two of the validation lots had out of specification (OOS) results for the hardness test. However, in ... February 1, 2003; Validation Times
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Searle hit for OOS in multiple validation lots. (Human Drugs).
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