Home » Missing Parts of Batch Records Lead to 483 for Drugmaker
Missing Parts of Batch Records Lead to 483 for Drugmaker
Incomplete batch records and poor testing of finished drugs resulted in a Form 483 for Cerovene. During an October inspection of the company’s Valley Cottage, N.Y., facility, investigators found that Cerovene’s batch records for drug-coated capsules didn’t include the in-process testing for identity, purity and quality.
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