FDA EIR - AGILENT TECHNOLOGIES INC./US - August 07, 2019

This FDA Establishment Inspection Report details a surveillance inspection of Agilent Technologies Inc.'s facility in Frederick, Colorado, conducted from August 5 to August 7, 2019. The inspection focused on the company's compliance with Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients (APIs), specifically for the intended manufacture of oligonucleotides. The regulatory framework for this inspection included Compliance Program 7356.002F (Drug Manufacturing Inspections) and ICH Guidelines Q7 GMPs for APIs.

As an initial inspection for this newly registered drug manufacturer, the FDA evaluated the firm's Quality System and Facilities System, reviewing documents related to air handling, processing equipment, and water system qualifications. Notably, the inspection concluded with no findings of objectionable conditions. Consequently, no FDA Form 483 Inspectional Observation List was issued, and no verbal objectionable items were discussed with management. No samples were collected, and no refusals were encountered during the three-day inspection. The company was generally reminded of the importance of adhering to applicable cGMPs.