# FDA 483 - Agilent Technologies Inc - August 02, 2019

Source: https://www.keypedia.com/records/483/agilent-technologies-inc/3b469df1-6b6c-451e-b98c-b3325cf97623

> FDA 483 for Agilent Technologies Inc on August 02, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Agilent Technologies Inc
- Inspection Date: 2019-08-02
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Between July 29 and August 2, 2019, the FDA conducted an inspection of the Agilent Technologies, Inc. facility in Boulder, Colorado, which operates as an Active Pharmaceutical Ingredient (API) manufacturer. The inspection resulted in the issuance of a Form 483 due to several significant quality control failures.

The primary violations centered on the firm’s failure to conduct thorough laboratory investigations. In multiple instances, the company encountered failing test results but attributed them to 'dirty glassware' or 'preparation errors' without performing a root cause analysis or investigating the underlying methods and calculations. The FDA noted that the firm frequently invalidated original high-measurement results as outliers and performed retests until passing results were achieved, lacking the statistical tools or procedures to justify such actions. Additionally, the company’s internal procedures for nonconformances were found inadequate, as they permitted retesting without requiring actions to prevent the recurrence of errors. Finally, the facility failed to follow established protocols for preventing microbial contamination in non-sterile drug substances, specifically regarding inadequate testing conditions.

Under this regulatory framework, these observations represent a preliminary assessment of compliance with manufacturing standards. Agilent Technologies is expected to respond to the FDA by either addressing the objections raised or submitting a detailed plan for corrective actions to resolve the identified deficiencies.

## Related Officers

- [Compliance Officer / Investigator](https://www.keypedia.com/people/erika-v-butler/3e654530-4c29-403d-880e-a5422315c3c0)
- [company_representative](https://www.keypedia.com/people/brian-s-carothers/b24c69ae-0bfd-460c-82c6-658210813c26)

Company: https://www.keypedia.com/companies/agilent-technologies-inc/865fe026-9db0-4e3e-bc4a-e0d25b465093

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face