# FDA 483 - Agilent Technologies, Inc. - July 17, 2025

Source: https://www.keypedia.com/records/483/agilent-technologies-inc/43813306-49ee-4f1a-b84d-367c962e95e8

> FDA 483 for Agilent Technologies, Inc. on July 17, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Agilent Technologies, Inc.
- Inspection Date: 2025-07-17
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: Agilent Technologies, Inc. in Carpinteria, CA, received a Form FDA 483 for inadequate corrective and preventive action (CAPA) procedures. The firm failed to properly document risk-based decisions for product corrections, did not adequately document field actions related to mislabeled kits with incorrect expiration dates, and miscategorized actions for unsubmitted PMA annual reports. These deficiencies indicate a systemic issue in managing quality problems and ensuring regulatory compliance.

## Related Documents

- [483 - 2025-07-17](https://www.keypedia.com/records/483/agilent-technologies-inc/5f2dbeda-4101-40a1-80a8-77b99d5fa156)
- [483 - 2025-07-17](https://www.keypedia.com/records/483/agilent-technologies-inc/3e571e64-d0ef-42a4-bf64-835ac3009e38)

## Related Officers

- [Medical Device Specialist](https://www.keypedia.com/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.keypedia.com/companies/agilent-technologies-inc/480d273c-0e5e-44b6-b766-a13ec00b422c

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b