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Denson’s Specialty Pharmacy Lands Form 483 for GMP Issues

November 8, 2016

The FDA has issued a Form 483 to Denson’s Specialty Pharmacy for repeated unsterile compounding issues and now invalid production of prescriptions.

An FDA investigator found that the company was not receiving valid prescriptions for individually identified patients for a portion of the drug products it was producing.

In addition, the investigator observed serious deficiencies in Denson’s practices for producing sterile drug products such as exposing sterile items to unclassified room air, as well as an operator transferring items into the laminar airflow hood without being disinfected.

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