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Pharmaceuticals / Inspections and Audits

Vilvet Pharmaceutical Draws FDA Warning for Quality Violations

March 13, 2019

The FDA hit Pennsylvania drugmaker Vilvet Pharmaceutical with a warning letter for quality violations at its Chester Springs facility.

In a June 18-27, 2018 inspection, agency officials found that the facility lacked proper written procedures for reviewing batches made by a contract supplier. It also didn’t review each supplier-produced batch to determine if it was suitable for release.

The agency warned Vilvet for not performing final reviews of each batch, even though the supplier had agreed to bear responsibility for all approvals or rejections.

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