FDA 483 - Oakdell Pharmacy, LLC - March 01, 2013

This FDA Form 483 document details observations from an inspection concerning the manufacturing of sterile drug products. The facility exhibits deficiencies in procedures designed to prevent microbiological contamination.

Specifically, the firm lacks written procedures for aseptic operations in ISO 5 and ISO 7 classified areas. Gowning requirements for personnel in ISO 8, ISO 7, and ISO 5 areas are deemed inappropriate, consisting of a single pair of sterile gloves, non-sterile shoe covers, a non-sterile lint-free lab coat, a hair net, and a single ear-loop face mask.

Separate or defined areas to prevent contamination are deficient, as the firm has not evaluated equipment contact surfaces or facility layout to prevent contamination in ISO 5, ISO 7, and ISO 8 classified areas. The system for cleaning and disinfecting aseptic processing areas is inadequate, lacking a written procedure for the rotation of cleaning agents and sporicides for the ISO 5 laminar air-flow hood, ISO 7 area, and ISO 8 ANTE room.

Environmental monitoring of ISO 5 classified areas during sterile drug processing is not governed by a written procedure. Furthermore, there is no written testing program to assess drug product stability, despite approximately 80% of compounded products receiving extended beyond-use dates without a defined validation procedure or stability protocol specifications. Finally, media fill validations for pharmacists performing aseptic operations do not include all sources of potential contamination typical of normal operating conditions, indicating inadequate validation of the sterilization process.