FDA Form 483: Excel-Based Data Falsification and Duplicate Log Books

Excel spreadsheets remain widely used in GMP-regulated environments. Yet without adequate controls, they can introduce considerable data integrity risks. This news item illustrates the issue by referring to an FDA Form 483 in which investigators identified fabricated Excel-based production records, deleted electronic files, and duplicate log books.

During an inspection from 29 July to 2 August 2024, FDA investigators found extensive data integrity deficiencies at an API manufacturing site in India. The Form 483 describes deliberate fabrication of batch documentation, contradictory log books, and uncontrolled QC notebooks – all of which undermine the reliability of data supporting products supplied to the US market.

Excel Used to Fabricate Production Records

One of the most critical findings concerns the use of Microsoft Excel to generate pre-planned entries for batch documentation. Spreadsheet templates created by the Plant Manager instructed employees to complete batch records, equipment logs, and cleaning records for activities that never occurred. FDA observed:

• Excel-generated plans attached to blank batch records.
• Fabricated records for powder and liquid batches.
• Signatures from production employees on falsified documentation.
• Deletion of all Excel files from the manager’s computer on the evening before FDA review.

Duplicate Log Books Enable Conflicting Records

The inspection also revealed duplicate sets of cleaning and equipment log books issued by QA using the same issuance numbers. These conflicting documents showed different batches being manufactured on the same equipment at the same time – and were nonetheless reviewed and approved by QA.

Such duplications create opportunities for backdating, reconstruction of records, and selective use of documentation.

Uncontrolled QC Notebooks and Retrospective Transcription

Within the QC laboratory, investigators found uncontrolled notebooks containing analytical measurements (assay, LOD, pH, weights, etc.). Analysts were observed transcribing data from these uncontrolled sources into official test reports during the inspection. Review of the notebooks revealed testing for batches produced in different blocks, including material reportedly manufactured in a separate plant.

This practice compromises traceability and challenges the integrity of analytical results.

Why Excel Governance Matters

The case provides a clear reminder that spreadsheets must be treated as GxP-relevant systems. The challenge is that:

• They lack inherent audit trails.
• They are vulnerable to undetected overwriting, copying, or deletion.
• They can facilitate fabrication when used as unofficial templates for documentation.

Therefore, their use requires formal version control, restricted access, validation (where appropriate), and transparent change management.

In many FDA enforcement cases, spreadsheets represent a weak point in otherwise robust digital environments – and this Form 483 reinforces that risk.

The complete FDA Form 483 can be found on the FDA's website.