FDA 483 - New England Life Care, Inc. - March 02, 2018

The FDA Form 483 details multiple deficiencies at a facility producing sterile drugs for human use, including cytotoxic and beta-lactam drugs.

Key violations include inadequate HEPA filter coverage and airflow in ISO 5 areas, which were not certified under dynamic conditions. Aseptic simulations (media fills) were insufficient, lacking performance in all production ISO 5 laminar flow hoods and the biosafety cabinet used for cytotoxic drugs. The air pressure differential for the hazardous drug biosafety cabinet was not consistently recorded.

Visible stains were observed on HEPA filters in ISO 5 laminar flow hoods without written evaluation procedures or acceptance criteria. HEPA certification testing reports lacked "as found" data, and filter leaks were not investigated for product risk or root cause. HEPA filter replacement was not preceded by "as found" performance testing.

Significant cross-contamination risks were identified for beta-lactam drugs due to inadequate containment, segregation, and cleaning. Beta-lactam antibiotics were processed in the same laminar flow hoods as other drugs, with only a wipe-down between products, and no specific process for deactivating beta-lactam spills.

Furthermore, materials and supplies were not disinfected before entering aseptic processing areas, and drug product components and process equipment stored in the ISO 7 buffer area were not sanitized immediately before entering ISO 5 laminar flow hoods. Personnel engaged in aseptic processing were observed with exposed hair, and disinfecting agents and cleaning wipes used in ISO 5 areas were not sterile.