Smoke Studies

A review of the Form 483’s issued to the 45-registered and inspected 503B Outsourcing Facilities identifies that over 40% (n = 19) of the inspected facilities received one or more observations concerning inadequate smoke studies. Common findings of the smoke studies included studies that were not performed under dynamic conditions, studies that do not adequately reflect […]

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Critical Airflow in Compounding Facilities

Based on a review of FDA Form 483’s issued to compounding facilities for inspections that occurred January to July 2017, 22 separate citations have been identified for critical airflow visualization.  Critical airflow is a key element in the protection of sterile product from contamination.  A summary of these citations include: The design, construction, and operation […]

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