Global Calcium Pvt. Limited Receives FDA Warning Letter Over Falsified Batch Records and Deleted Electronic Files

Falsified batch records and the deliberate deletion of electronic files during an FDA inspection have placed Global Calcium Pvt. Limited in direct conflict with 21 CFR Part 211 CGMP requirements for API manufacturers, with the agency formally declaring the company's APIs adulterated under section 501(a)(2)(B) of the FD&C Act. The warning letter, issued January 16, 2025, follows an inspection at the firm's Hosur, Tamil Nadu facility conducted July 29 to August 2, 2024.

Investigators identified production records showing two different APIs manufactured simultaneously on the same equipment, a physical impossibility that points to non-contemporaneous record preparation. More critically, Microsoft Excel files observed on the first morning of the inspection, including cleaning validation samples and production reports, were entirely deleted by the second day. The company later acknowledged the files were removed to "avoid unwanted conversation" with investigators, and that the production head had directed creation of falsified manufacturing records to misrepresent output and claim production incentives.

FDA's rejection of Global Calcium's post-inspection response carries direct implications for QA directors and regulatory affairs leads at API sites operating under similar documentation frameworks. The agency found the company's product quality impact assessment inherently unreliable because it drew on data generated by the same deficient documentation system under review. The response also failed to define the scope of record fabrication across the facility, identify which records were legitimate, or detail controls sufficient to prevent, detect, and investigate non-contemporaneously prepared records going forward.

For plant heads, the operational read is unambiguous: ICH Q10 pharmaceutical quality system principles require that the quality unit maintain independent oversight of documentation integrity, including electronic records not formally designated as GMP systems. The FDA's concern here extends beyond the falsified batch records themselves, the use of uncontrolled desktop files for production tracking, and the absence of audit trail controls on those files, represents a systemic gap that a CAPA revision to a single SOP will not close.

The agency's explicit concern about the adequacy of Global Calcium's corrective commitments signals that a re-inspection or import alert remains a live possibility until the firm can demonstrate facility-wide data integrity remediation with independently verifiable evidence.

Source: U.S. Food and Drug Administration, Warning Letter 320-25-30, via FDA.gov What's New: Drugs RSS Feed, January 16, 2025.