FDA EIR - MacroGenics, Inc - April 06, 2021

An FDA pre-license inspection of MacroGenics, Inc.'s drug substance manufacturing facility in Rockville, MD, was conducted from March 24 to April 6, 2021. The inspection aimed to assess the facility's readiness for drug substance manufacturing, adhering to FDA compliance programs and ICH Q7 Good Manufacturing Practice Guidance. The inspection resulted in eight observations cited on a Form FDA 483.

Key issues included a lack of adequate written procedures to prevent microbiological contamination during cell culture manufacturing and insufficient controls for stand-alone electronic data acquisition and process control systems, raising data integrity concerns. The firm also failed to adequately review service contractor reports for cleanroom and biological safety cabinet certification, impacting the validation state of critical equipment. Further observations noted a lack of assurance regarding the reliability of a specific bioassay for drug substance release and stability testing, and concerns about the effectiveness of cleaning procedures for product-contact equipment to prevent cross-contamination.

Additionally, the FDA identified the absence of a robust cleaning and sanitization program for controlled manufacturing environments and inadequately qualified critical clean utilities. Lastly, changes to written procedures were not thoroughly reviewed, failing to ensure all impacted materials were evaluated. MacroGenics management committed to providing a written response to the FDA within 15 business days.