New England Life Care, Inc. – FDA 483, Feb 8, 2018

An FDA inspection of New England Life Care, Inc. was conducted from January 31 to February 8, 2018, revealing critical deficiencies in their sterile drug product manufacturing processes. The firm, a producer of sterile drug products, received an FDA 483 detailing multiple observations related to maintaining an aseptic environment.

Main violations included inadequate personnel aseptic technique, where technicians compromised ISO 5 classified aseptic processing areas by rapid movements, exposing bare skin, and failing to sanitize gloves. Environmental controls were found lacking, specifically with inadequate HEPA filter coverage and airflow; requalifications of laminar flow hoods did not accurately reflect operational setups, especially for Total Parenteral Nutrition (TPN) processing. A significant cross-contamination risk was identified due to insufficient segregation of beta-lactam drugs from other products, processed in the same hoods with only a wipe-down and no decontamination process for spills. Additionally, non-microbial contamination, such as stained ceiling tiles, was present in the production area, and non-sterile disinfectants were used for sanitizing critical ISO 5 aseptic processing hoods. These observations indicate non-compliance with good manufacturing practices, and New England Life Care, Inc. is required to implement thorough corrective actions to ensure product sterility and quality.