FDA issues Warning Letter on Data Integrity concerns

On June 18, 2024, the FDA issued a Warning Letter to Dominican company Laboratorio Magnachem International for CGMP violations, following a November 2023 inspection. The FDA found the company’s December 1, 2023, response to Form 483 issues inadequate, particularly regarding data integrity violations. Key issues included:

- Lack of access controls and protection for laboratory equipment.
- No prevention of data deletion or alteration.
- Absence of unique user credentials.
- Uncontrolled access to modify HPLC files.
- Inadequate data backup and tracking of data changes.

The company’s response, which involved assessing a new supplier for data management, did not satisfy the FDA. The FDA expects:

- A comprehensive review of documentation systems.
- A detailed CAPA plan for documentation and computer system security.
- Interim controls and implementation timelines.

The company did not take interim actions such as customer notifications or product recalls.