The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs / GMPs / Inspections and Audits

Missing Parts of Batch Records Lead to 483 for Drugmaker

Feb. 14, 2014
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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.
Drug GMP Report