QC Lab Hell: Insight into Failure

The Top 5 FDA Observations in QC Labs — And How to Avoid Them

By Troy Fugate Vice President, Compliance Insight www.compliance-insight.com

The Quality Control (QC) laboratory remains one of the FDA’s favorite hunting grounds during inspections — and for good reason. Your lab touches every product batch. It either confirms your process is under control, or it exposes the gaps you hoped weren’t there.

And when things go wrong in the lab, they tend to go wrong in writing.

Here are the five most common — and costly — FDA observations we continue to see in QC labs, and what you can do to stay off the radar (or out of the 483).

1. Incomplete or Inaccurate Data Records

“Failure to ensure complete data integrity in laboratory notebooks and electronic systems.”

What FDA means: Analysts fail to document actions contemporaneously, calculations aren’t traceable, raw data is missing, or audit trails are turned off or ignored.

How to avoid it:

• Ensure real-time documentation — no backdating, no batch record guesswork.
• Implement and review audit trails from electronic systems.
• Train staff on ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring, Available).
• Audit lab notebooks regularly for completeness and clarity.

Bottom line: If you didn’t document it, it didn’t happen — and if you documented it after the fact, it happened wrong.

2. Inadequate Investigation of Out-of-Spec (OOS) Results

“Failure to thoroughly investigate and document OOS and aberrant results.”

What FDA means: You're blaming analysts, instruments, or "random error" without solid evidence — or worse, retesting into compliance.

How to avoid it:

• Follow FDA’s Guidance on OOS Investigations to the letter.
• Treat all atypical results seriously — including out-of-trend (OOT), invalid runs, and recurring analyst errors.
• Require a multi-level review of all lab investigations.
• Never allow retesting until Phase I (laboratory investigation) is complete and justified.

Remember: Investigations aren’t about blame — they’re about root cause and control. If your response to an OOS is just “retest,” you're headed for trouble.

3. Poor Instrument Qualification and Maintenance

“Instruments used for testing not properly qualified, calibrated, or maintained.”

What FDA means: Equipment is being used outside its validated state — or preventive maintenance is a checkbox, not a control.

How to avoid it:

• Maintain clear qualification packages for every piece of lab equipment.
• Track calibration and maintenance in an electronic system — with automated alerts for overdue tasks.
• Define out-of-tolerance response procedures (e.g., impact assessment for batches tested since last passing calibration).

Key message: If the integrity of your data relies on an instrument, the integrity of that instrument must be proven — continuously.

4. Unvalidated or Unverified Test Methods

“Failure to use validated or verified methods for testing products.”

What FDA means: You’re using compendial methods without verification, or in-house methods that weren’t validated properly for their intended use.

How to avoid it:

• For compendial methods: Always perform method verification (specificity, accuracy, precision) for your product matrix.
• For non-compendial: Conduct full method validation per ICH Q2(R1).
• Maintain change control for any method revisions or transfers.

Tip: Many labs wrongly assume that “USP = no need to verify.” The FDA disagrees — and expects verification for your specific product and formulation.

5. Lack of Training or Competency Documentation

“Personnel not adequately trained or qualified for their assigned laboratory duties.”

What FDA means: Your people are operating instruments, interpreting results, and documenting data — but you can’t prove they’re trained to do so.

How to avoid it:

• Establish a competency-based training program, not just read-and-understand.
• Track practical qualifications for each assay, method, and instrument — signed off by a qualified trainer.
• Reassess skills regularly and after procedural changes.

Remember: An SOP signature page is not a competency assessment. The FDA expects clear evidence that your people can do the job and do it right.

Final Thought: Your QC Lab Is a Window Into Your Culture

When the FDA walks into your lab, they’re not just looking at data — they’re looking at how your organization thinks.

Do you investigate problems or bury them? Do your systems enable transparency or disguise it? Do your analysts feel pressure to pass results — or freedom to report them honestly?

Want to know if your lab is inspection-ready — or inspection-vulnerable? Let’s talk.

— Troy Fugate Vice President, Compliance Insight www.compliance-insight.com

Helping you protect your products, your patients, and your professional legacy.

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