FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Florida Drugmaker Draws FDA Warning for Repackaging, Distribution

May 10, 2018

The FDA warned Phase 4 Pharmaceutical for repackaging deficiencies and inadequate drug distribution procedures at its Aventura, Florida facility.

The agency noted in an April 2017 inspection that the firm had no quality control unit for its drug repackaging operation, which repackaged over-the-counter transdermal patch drug products in zippered plastic bags. It also lacked written procedures for its repackaging operations or quality control unit tasks.

In response to the inspection observations, the firm sent the agency a quality control procedure that referenced food regulations and had no applicability to drug product manufacturing.

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