Tracking Pharma Audits, Warning Letters & Compliance Updates
Welcome to LabSoln Regulatory News — your trusted source for the latest updates on pharmaceutical regulatory inspections, audit outcomes, warning letters, and compliance trends from global agencies like USFDA, MHRA, EMA, and CDSCO.
Stay informed about data integrity issues, GMP violations, OOS/OOT handling, and laboratory compliance — the most critical focus areas in today’s regulated pharma environment.
October 2025
USFDA Warning Letter to Gujarat-Based API Manufacturer
The U.S. FDA issued a warning letter to an Indian API manufacturer following inspectional findings related to data integrity and documentation control.
Key Observations:
Multiple unreported test repeats Missing audit trails for chromatography runs Incomplete sample disposal records
💡 Takeaway: Strengthen your CDS data security, implement audit trail reviews, and maintain real-time documentation to ensure 21 CFR Part 11 compliance.
September 2025
MHRA Flags Inadequate OOS Investigations at Hyderabad Formulation Site
An MHRA inspection identified procedural weaknesses in Out-of-Specification (OOS) investigations and incomplete CAPA documentation.
Key Observations:
Delayed OOS investigations Lack of QA oversight during root cause analysis Missing evidence for CAPA effectiveness checks
💡 Takeaway: Ensure your LIMS/CDS systems support traceable, multi-level OOS review workflows to avoid regulatory risk.
August 2025
CDSCO Cancels Manufacturing License Over GMP Non-Compliance
The CDSCO suspended operations of a small-scale manufacturer in Himachal Pradesh after repeated GMP violations and poor documentation practices.
Key Observations:
Uncalibrated instruments used in QC testing Missing logbooks for critical utilities Non-traceable batch records
💡 Takeaway: Regular self-audits and digital equipment qualification records can help prevent serious regulatory action.
July 2025
EMA Notes Inadequate Data Backup Policies at European Site
The European Medicines Agency (EMA) raised major observations during an inspection of a generics manufacturing site related to data backup and archiving of analytical systems.
Key Observations:
No verification of backup integrity Data stored on unsecured local drives Lack of defined retention policies
💡 Takeaway: Implement automated, validated data backup solutions with periodic restoration tests to maintain data integrity.
Emerging Trends in Regulatory Audits (2025)
Heightened scrutiny of data integrity and audit trail review Increased focus on method validation and lifecycle documentation Global alignment toward electronic record governance (ERES) More frequent follow-up inspections post-warning letters
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