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21 CFR 211.192 21 CFR 211.192 (failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed) was cited 30 times
Healthcare providers cannot prescribe it through normal pharmaceutical channels
Hand disorders in children with mucopolysaccharide storage diseases
Lot-level COAs are generated as a standard output of the manufacturing quality system
