Case Studies
We were retained to provide our expert opinion on insurance claims concerning FDA regulations and compliance with local and federal statutes related to the source and impact of mold detected at a pharmaceutical manufacturing facility. We were asked to review procedures meant to prevent microbiological contamination of sterile drug products, quality control (QC) procedures that could impact drug manufacturing, and written records of investigations into unexplained discrepancies.
We investigated the root cause of mold contamination within a clean area of the facility. The project involved investigations into the timeline of actions and the scientific data that supported the claims being made by both the FDA and the manufacturer. The FDA inspection revealed deficiencies in the procedures intended to prevent microbiological contamination in sterile drug production. Our investigation determined that ongoing maintenance issues and substandard manufacturing practices at the facility were the main factors contributing to the persistent mold contamination.
Javier Rubio Villa
Senior Toxicologist
Environmental, Health & Safety
+1 719 319 0341
[email protected]
> Industrial Hygiene Services
Our team of Certified Industrial Hygienists (CIHs), Certified Safety Professionals (CSPs), and environmental scientists provide expert counsel on matters involving asbestos, lead, mold, legionella, smoke, noise, occupational risks, and other hazards.
> Environmental, Health & Safety
Our EHS consultants provide specialized expertise in environmental damage and remediation, environmental due diligence, energy transition, toxicology and epidemiology, industrial hygiene, product stewardship and product liability, and human health and safety.