Specialty Compounding, LLC – FDA 483, May 5, 2015

The FDA Form 483 documents observations from an inspection of a firm producing sterile drugs. The firm failed to establish adequate procedures for media fill simulations, with recent fills (4/30/2014, 10/1/2014) for ISO 5 LAF hood operators not closely simulating planned production.

The facility design is unsuitable regarding personnel and material flow, room segregation, process separation, and HVAC/air pressurization/unidirectional airflow, potentially causing contamination. Specifically, smoke studies (9/2014) for ISO 5 LAF Hood #1 showed non-unidirectional airflow and air backflow into the ISO-5, without evaluation. A window in the Sterile Processing Room, used as a pass-through for dirty glassware from the ISO 7 area to an unclassified area, has not been assessed for air influx from the unclassified area into the ISO 7 when opened.

Operational procedures to prevent microbiological contamination of sterile drugs are inadequate. A depyrogenation oven was qualified (3/24/2015) using a test indicating a specific requirement, but the firm has not determined where this requirement was met.

The firm lacks adequate written Standard Operating Procedures for maintaining aseptic processing areas and equipment, specifically for cleaning glassware used in sterile drug production.

Finally, the firm failed to ensure label accuracy for finished preparations. For example, the product Methylcobalamin/RG3 (90