FDA EIR - Agilent Technologies Inc - August 02, 2019

An FDA inspection of Agilent Technologies Inc. in Boulder, CO, took place from July 29 to August 2, 2019. This inspection included Good Manufacturing Practice (GMP) surveillance for Active Pharmaceutical Ingredient (API) manufacturing and a Pre-Approval Inspection under Compliance Program 7346.832. The inspection concluded with an FDA Form 483 listing three observations.

The main issues identified concerned the company's laboratory operations. Specifically, laboratory investigations for nonconformances and aberrant data were found to be incomplete and did not consistently identify root causes. The procedure (QC-SOP-6001.23) for such investigations was deemed inadequate, permitting retesting without thoroughly addressing the underlying issues to prevent recurrence. Additionally, procedures intended to prevent objectionable microorganisms in non-sterile API drug substances were not adhered to; inadequate testing prior to incubation was observed, which could inhibit microorganism detection.

Management, including Vice President and General Manager Mr. Brian S. Carothers, acknowledged the FDA Form 483 and committed to submitting an electronic response addressing each observation to the FDA Denver District office. The consequences of non-compliance with GMPs, such as warning letters, product seizure, and operational injunctions, were discussed. As voluntary corrective actions, Agilent Technologies Inc. provided training for QC microbiologists and stated intentions to revise relevant procedures for detailed instructions.