FDA Warning Letter regarding Raw Data Review and missing Audit Trails

On 24 February 2025, the FDA issued a warning letter to Aspen Pharmacare Holdings Limited due to CGMP violations identified during an inspection in September 2024. The company’s response to the Form 483 issued on 8 October 2024 was deemed insufficient by the FDA.

The data integrity violations included failures to properly control electronic records and audit trails, particularly in the filter integrity tests, where only passed results were recorded and printed. The company acknowledged this issue but failed to provide detailed investigation findings, corrective actions (CAPA), or a review of affected batches.

The FDA expects the company to:

• Conduct a comprehensive investigation into the extent of the data integrity issues.
• Provide a risk assessment regarding the impact on drug quality.
• Implement a global CAPA plan.
• Ensure the Quality Unit (QU) has the authority and resources to oversee operations effectively, with proper procedures for reviewing critical electronic data.

05-05-2025