FDA 483 - New England Life Care, Inc. dba Advanced Compounding Solutions - April 28, 2022

This FDA Form 483 was issued to New England Life Care, Inc. dba Advanced Compounding Solutions, an Outsourcing Facility located at 4 Constitution Way Ste L, Woburn, MA, following an inspection from March 21 to April 28, 2022.

The inspection revealed seven observations:

1. **Failure to thoroughly review unexplained discrepancies:** The firm failed to investigate 21 out of 24 environmental monitoring excursions in 2022, including five in March 2022. Products were released into distribution despite open investigations into viable air and personnel monitoring excursions involving spore-forming organisms like *Bacillus licheniformis* and *Brevibacillus brevis*, and *Staphylococcus hominis*.

2. **Failure to follow procedures to prevent microbiological contamination:** Pharmacy technicians were observed with exposed skin during manufacturing operations, potentially allowing particulates into ISO 5 and ISO 7 areas. Operators were also observed blocking first-pass air in ISO 5 hoods with equipment and environmental monitoring plates during production of sterile drug products.

3. **Deficient aseptic processing area cleaning and disinfection:** The firm failed to validate its cleaning processes and agents for ISO 5, ISO 7, and ISO 8 areas and equipment. Insanitary conditions were observed, including standing liquid, rust, paint chipping, scratches, and unidentified residue on surfaces and equipment in classified areas. Cleaning of power cables was not performed