ARTICLE

FDA Launches One-Day Inspectional Assessments Pilot Program

In April 2026, the FDA initiated a pilot program for one-day inspectional assessments aimed at enhancing the efficiency of its oversight. This program is designed to provide shorter, focused reviews that complement...

REGULATORY · FDA

One-Day Assessments Focus on Risk-Based Compliance

The FDA's one-day assessments are part of a strategy to deploy inspection resources more efficiently. Facilities selected for these assessments will undergo narrower, issue-focused reviews driven by risk...

REGULATORY · FDA

QMSR Changes Impact Device Inspections

The FDA's adoption of the Quality Management System Regulation (QMSR) is reshaping device inspections into risk-driven, lifecycle-focused evaluations. This includes expanded authority for remote record requests.

REGULATORY · FDA

Remote Regulatory Assessments Gain Traction

The FDA is expanding its operational use of remote records review, allowing oversight activities to occur before or instead of an on-site inspection, enhancing compliance monitoring.

MANUFACTURING · FDA

Critical GMP Observations Persist in Inspections

Over 70% of pharmaceutical plants are still receiving critical GMP observations, primarily due to documentation and training record weaknesses. This highlights the need for improved compliance practices.

MANUFACTURING · FDA

Majority of Facilities Achieve Acceptable CGMP Status

Despite challenges, more than 90% of inspected facilities meet acceptable CGMP status, indicating that while serious deficiencies exist, most sites comply with minimum expectations.

MANUFACTURING · FDA

Focus on Data Integrity and Process Controls

Recent analyses reveal that CGMP documentation, data integrity, and process controls are frequent sources of Form 483 observations, underscoring areas for improvement in compliance.