FDA 483 - leiter's cambrian park drugs, inc., - November 05, 2013

During an inspection from October 22 to November 5, 2013, the FDA identified significant manufacturing deficiencies at Leiter's Cambrian Park Drugs, Inc., operating as Leiter's Pharmacy, a producer of sterile drugs in San Jose, CA. The inspection, documented in an FDA Form 483, revealed widespread non-compliance with current Good Manufacturing Practices (cGMP) for sterile drug production. Key violations included a severe lack of validation for sterilization processes, with missing media fill incubation records and unvalidated equipment. The firm also failed to thoroughly investigate a positive sterility test result for a Bevacizumab injection batch, which showed microbial contamination, without a documented root cause analysis. Aseptic processing areas were compromised by inadequate environmental monitoring, a lack of airflow evaluations, and insufficient cleaning and disinfection procedures. Protective apparel protocols were also found deficient, with personnel exhibiting improper gowning and hygiene practices that risked product contamination. Furthermore, quality control procedures were inadequate, with records not being reviewed, critical gauges uncalibrated, and a lack of written procedures for cleaning agents and shipping validation. The facility's space was deemed insufficient, contributing to contamination risks and operational constraints. Leiter's Pharmacy is required to promptly address these systemic failures to ensure the safety, identity, strength, quality, and purity of its sterile drug products, providing a comprehensive response outlining corrective and preventive actions to the FDA.