FDA 483 - Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy - April 05, 2019

This FDA Form 483 document outlines observations made during an inspection of an unnamed facility's aseptic processing operations. The facility utilizes ISO 5 classified aseptic processing areas.

The inspection revealed several deficiencies related to facility maintenance and contamination control. Specifically, equipment and surfaces within the ISO 5 classified aseptic processing areas were noted as being difficult to clean and visibly dirty. Furthermore, non-microbial contamination was observed in the production area. A critical finding was the presence of unsealed, loose ceiling tiles in the cleanroom, which poses a significant risk for particulate contamination and maintaining the required cleanroom environment.

These observations indicate potential issues with the facility's quality system regarding environmental control, cleaning procedures, and overall manufacturing hygiene, which could impact product quality and sterility assurance. The document does not specify regulatory citations or business/operational implications beyond the direct observations.