FDA WARNING_LETTER - Shiva Analyticals Private Limited - January 24, 2025

**FDA Warning Letter Summary**

**Company:** Shiva Analyticals (India) Private Limited **Location:** Plot 24D (P) and 34D KIADB Industrial Area, Hoskote, Bangaluru, Karnataka, India **Inspection Dates:** January 20-24, 2025 **Date of Warning Letter:** July 23, 2025

**Main Violations/Issues:** 1. **Inadequate Investigation of Discrepancies:** Shiva Analyticals failed to thoroughly investigate unexplained discrepancies or failures in batch specifications, particularly out-of-specification (OOS) results. Investigations lacked scientific rationale and did not extend to previously analyzed batches. New test results were improperly used to invalidate OOS results without adequate root cause analysis.

2. **Inadequate Corrective and Preventive Actions (CAPA):** The firm did not implement effective CAPA to address recurring human errors contributing to laboratory incidents and OOS investigations. Standard operating procedures (SOPs) for handling such results were found inadequate.

3. **Data Integrity Issues:** Investigators found torn and discarded original CGMP documents, including analytical records, in waste disposal areas. There were unauthorized modifications to electronic data, compromising data integrity.

4. **Quality Control Lapses:** The quality control unit failed to ensure the reliability and integrity of analytical testing data, with significant deficiencies in oversight and document control.

**Regulatory Framework:** Violations of Current Good Manufacturing Practice (CGMP) regulations under 21 CFR parts 210 and 211, leading to drug products being considered adulterated under section 501(a)(2)(B) of the FD&C Act.

**Required Actions:** - Conduct a thorough investigation into the causes of violations and implement measures to prevent recurrence. - Engage a qualified CGMP consultant to assist in compliance efforts. - Provide a detailed response addressing how the firm will ensure adequate investigation of OOS results and improve data integrity and quality systems. - Correct