FDA Warns Bangalore Testing Lab Over CGMP Breaches

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Shiva Analyticals Private Limited in Bangalore, India, following a January 20–24, 2025 inspection that uncovered significant Current Good Manufacturing Practice (CGMP) violations.

Inspectors reported inadequate investigations into out-of-specification (OOS) results, noting that root cause analysis lacked scientific rigor and repeat errors were not effectively addressed. In some cases, new results were used to dismiss earlier OOS findings without valid justification.

The FDA also identified serious data integrity issues, including discarded original CGMP records and unauthorized changes to electronic data such as “Add/Modify/Delete peaks.”

The agency has directed a three-year retrospective review of all OOS incidents, independent assessments of documentation practices and analyst competency, and revised standard operating procedures with robust corrective actions. It also advised hiring an external CGMP consultant, while stressing that compliance responsibility rests with the company.

11-08-2025