# FDA 483 - Cambrex High Point, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/cambrex-high-point-inc/8208c7f3-e7f0-4250-b11d-351b1970ac6e

> FDA 483 for Cambrex High Point, Inc. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cambrex High Point, Inc.
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Cambrex High Point, Inc., an API manufacturer, received a Form 483 following an inspection from June 8-12, 2026. The inspection revealed a significant data integrity issue where the firm lacks adequate controls to ensure the accuracy of data recorded in batch production records, specifically regarding unreviewed Human Machine Interface (HMI)-generated data. This failure compromises the assurance of critical process parameter data used for Process Performance Qualification batches.

## Related Documents

- [EIR - 2014-12-17](https://www.keypedia.com/records/eir/cambrex-high-point-inc/a54e5bc3-4520-4b46-ab70-0c4a2870f5fc)

## Related Officers

- [Investigator](https://www.keypedia.com/people/sonya-m-edmonds/a38fad3f-f664-4c52-8e50-78782f56ff18)

Company: https://www.keypedia.com/companies/cambrex-high-point-inc/3d7434e4-9d4a-4e8d-bf6c-694dff7d6474

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7