FDA Highlights Data Integrity Risks of Excel in GMP Environments

An FDA inspection at Global Calcium Pvt. Limited, India, from 29 July–2 August 2024, revealed serious data integrity deficiencies, including fabricated production records, deleted files, and duplicate log books, all undermining the reliability of data for products supplied to the U.S.

Key Findings:

• Excel-Based Fabrication: Microsoft Excel templates were used to pre-plan batch records, equipment logs, and cleaning records for activities that never occurred. Investigators observed blank batch records with attached Excel plans, falsified signatures, and deletion of Excel files before the inspection.
• Duplicate Log Books: QA issued multiple log books with identical issuance numbers, creating conflicting records for the same equipment and batches, enabling backdating and selective reporting.
• Uncontrolled QC Notebooks: Analysts transcribed data from unregulated notebooks into official test reports, compromising traceability and analytical integrity.

Implications: Spreadsheets in GMP settings must be treated as GxP-relevant systems, with formal version control, restricted access, validation, and audit-ready change management to prevent data manipulation.

The full FDA Form 483 is available on the FDA website.

18-12-2025