FDA Warns Impax Over Drug Testing At Calif. Plant
An FDA on-site inspection revealed Impax inadequately sampled and tested in-process materials and finished drugs at its Hayward, Calif., facility, the company said in a statement. The drugmaker also failed to review production records and investigate problematic manufacturing batches according to FDA guidelines, the warning letter said.
In response to the inspection, which took place between Dec. 13...
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