Three Red Flags in Your PQR That Could Raise a 483—Would You Spot Them?

If you’ve ever sat across from an FDA inspector, you know the tension that builds when they start flipping through your Product Quality Review (PQR) documentation. One misplaced number, one vague investigation summary, one missing link between deviations and CAPAs—and suddenly, you’re staring down the barrel of a 483. 

In this post, I want to share the three most common and costly red flags hidden in your PQR that could lead to an FDA observation. As someone who’s worked with pharma QA teams for years, I’ve seen these exact pitfalls trigger preventable warnings. The good news? You can fix them, now. 

Red Flag #1: Unlinked Deviations and CAPAs 

 A deviation without a clear CAPA (Corrective and Preventive Action) is like a diagnosis without a treatment plan. If your PQR lists product deviations but doesn’t track whether a CAPA was implemented, verified, or effective, you’re leaving a critical gap in your quality story. 

 What the FDA sees: “This manufacturer identifies problems, but does nothing to prevent recurrence.” 

 Fix it: Automate linkage between deviation logs and CAPA records. Even better, include CAPA effectiveness checks as part of your annual review. 

Red Flag #2: Inconsistent Data Across Batches or Systems 

 If your LIMS says one thing, your ERP another, and your PQR something else entirely—you’ve got a problem. Inspectors look for data integrity. Discrepancies in yield data, stability trends, or complaint metrics across systems raise instant red flags. 

 What the FDA sees: “This site has poor data control and lacks a single source of truth.” 

 Fix it: Standardize your data collection formats and implement system integration where possible. Centralized dashboards can help detect anomalies before the auditor does. 

Red Flag #3: Vague or Incomplete Trend Analyses 

 A PQR isn’t just a repository of records—it should tell a story. If your trend analysis on batch performance, OOS events, or customer complaints lacks specificity, statistical rigor, or actionable conclusions, it weakens your quality posture. 

 What the FDA sees: “This PQR goes through the motions but fails to drive improvement.” 

 Fix it: Use statistical tools and control charts to identify trends. Include clear summaries, root cause insights, and proposed quality initiatives in your review. 

Final Thoughts: Stay Off the Radar, Stay Audit-Ready 

 These red flags don’t just threaten compliance—they reflect missed opportunities to improve. A strong, insightful PQR tells the story of a company that takes quality seriously. It shows you’re not just ticking boxes, but actively learning and improving. 

Before your next inspection, take a walk through your last PQR. Spot the red flags, fix the cracks, and turn a compliance document into a quality asset.