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

Between August 5 and August 7, 2019, the FDA conducted an initial Good Manufacturing Practice (GMP) surveillance inspection at the Agilent Technologies Inc. facility in Frederick, Colorado. As a newly registered manufacturer for the company’s Nucleic Acid Solutions Division, the site is intended for the production of non-sterile active pharmaceutical ingredients (APIs), specifically oligonucleotides. The inspection was carried out under the regulatory framework of ICH Q7 guidelines for API manufacturing. During the three-day evaluation, investigators reviewed critical organizational systems, including the Quality, Facilities and Equipment, Production, Materials, and Laboratory systems. Specific attention was given to utility qualifications, such as air handling and water systems, as well as equipment validation protocols and training programs. The inspection aimed to ensure the facility was prepared for commercial manufacturing following its registration in February 2019. The inspection resulted in no identified violations or objectionable conditions. No FDA Form 483 was issued, and no samples were collected. Since no deficiencies were documented, Agilent Technologies is not required to take any corrective actions at this time. Facility management indicated that commercial manufacturing was expected to commence shortly after the inspection, with a continued commitment to maintaining established manufacturing standards.