FDA 483 - Eastern Pharmacy, Inc. - February 04, 2014

The FDA Form 483 details significant deficiencies in the repackaging of sterile Avastin (Bevacizumab) and Lucentis (Ranibizumab) drug products into individual syringes from June to December 2013.

The facility lacked established, written, and followed procedures to prevent microbiological contamination. Specifically, there were no written procedures for aseptic process validation, environmental monitoring (which was never performed), gowning, personnel qualification for gowning, or media fills (none conducted). The laminar air flow hood was reportedly used only as a working surface, not turned on. Cleaning procedures for aseptic equipment were inadequate, using only (b)(4) as a cleaning agent.

The aseptic processing area was deficient, lacking a smooth/sealed ceiling, a separating door, temperature/humidity controls, environmental monitoring, and HEPA-filtered positive pressure air supply. The laminar hood was not qualified or certified. Non-sterile gowns were used, and no documentation of sterile gowns or gloves was available.

Personnel lacked adequate training and experience for aseptic processing and gowning, with no documentation provided.

Finished drug products were not laboratory tested for sterility or endotoxin, and no finished product specifications existed for release. There was no written stability testing program, and no stability data supported the 30-day beyond-use-date for the repackaged syringes.