FDA halts production at Alabama drug compounder over unsanitary conditions

Foley, Ala.-based drug compounding company Medistat RX must cease all manufacturing and distribution operations following a complaint filed by the Department of Justice on behalf of the Food and Drug Administration.

Here are three things to know.

  1. Medistat manufactured and distributed supposedly sterile drug products produced in unsanitary conditions, which violated federal good manufacturing practices requirements. The drugs prepared, packaged or stored in the unsanitary conditions may have been contaminated with filth and could pose a threat to patients, according to the FDA.

  2. Medistat also manufactured and distributed unapproved drugs and misbranded medications with improper usage instructions on the label.

  3. Under a consent decree, Medistat must stop all operations until it complies with FDA safety regulations, among other requirements.

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