New England Life Care, Inc. dba Advanced Compounding Solutions – FDA Warning Letter, Apr 28, 2022

The FDA issued Warning Letter #430004 to New England Life Care, Inc. dba Advanced Compounding Solutions, an outsourcing facility, following an inspection from March 21 to April 28, 2022. The inspection revealed that drug products failed to meet Section 503B conditions of the FDCA and serious deficiencies in sterile drug production, posing patient risks.

Violations include adulterated drug products under FDCA Section 501(a)(2)(A) due to insanitary conditions, such as operators resting hands on work surfaces, blocked airflow, inadequate smoke studies, scratched surfaces, liquid pools, pest infestations, and blocked air returns. Additionally, drug products were adulterated under Section 501(a)(2)(B) due to CGMP violations, including failure to investigate discrepancies (21 CFR 211.192), inadequate complaint procedures (21 CFR 211.198(a)), insufficient procedures to prevent microbiological contamination (21 CFR 211.113(b)), inadequate cleaning systems (21 CFR 211.42(c)(10)(v)), poor facility maintenance (21 CFR 211.58), and inadequate air supply (21 CFR 211.42(c)(10)(iii)).

The facility also produced unapproved new drug products, violating FDCA Sections