FDA 483 - Emergent Manufacturing Operations Baltimore LLC. - April 20, 2021

This FDA Form 483 document details observations from an inspection of a facility manufacturing client viral vaccine drug substance. The inspection revealed multiple deficiencies related to quality systems, facility maintenance, and operational procedures.

Key observations include: - Failure to conduct thorough investigations into unexplained discrepancies. - The manufacturing building is not maintained in a clean and sanitary condition. - The building's size, design, and location are unsuitable for proper cleaning, maintenance, and operations. - Written production and process control procedures to prevent cross-contamination are not followed or documented at the time of performance. - Components, product containers, and closures are not handled or stored to prevent contamination. - Written procedures to assure drug substance identity, strength, quality, and purity are inadequate. - Employees lack training in specific operations and/or CGMPs relevant to their job functions. - Equipment is not of adequate size for intended use, cleaning, or maintenance. - Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination affecting drug substance safety, identity, strength, quality, or purity.

These findings indicate significant issues across quality control, facility management, personnel training, and manufacturing practices, impacting the overall compliance and quality of the drug substance production.