FDA 483 - Cambrex High Point, Inc.
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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.
- Company
- Cambrex High Point, Inc.
- Product Type
- Drugs
ID · 8208c7f3-e7f0-4250-b11d-351b1970ac6e