Winning the Inspection Game – The Habits of Inspection-Ready Companies
LIVE THE CULTURE: The entire organization, from top management to line operators, knows that quality isn’t a department—it’s a mindset. It’s part of the air you breathe, the decisions you make.
Follow SOPs consistently, encourage employees to report and fix problems and never take shortcuts on quality. Management should support this by providing adequate resources and not pressuring for output at the expense of compliance.
DOCUMENT LIKE A PRO: If it isn’t documented, it didn’t happen. Firms must keep accurate, timely, and accessible records of all aspects of production and control. Ensure that documents are reviewed and approved appropriately, and that data integrity principles are followed.
PRACTICE THE FIRE DRILL: Mock inspections. Surprise audits. Real-time CAPAs. These aren’t exercises. They are armor. They harden systems and sharpen people.
TEACH MORE THAN TASKS: Employees doesn’t just know how to do their job—they know why it matters. Because when people understand the stakes, they protect the mission.
It’s wise to have a core inspection team that has had specific training on Do’s and Don’ts during inspections.
FIX FAST AND LOUD: If something does go wrong – a batch deviation, an out-of-specification (OOS) lab result, a manufacturing mistake – address it proactively and thoroughly. Perform root cause analyses (RCA) and implement corrective and preventive actions (CAPA).
If a significant issue happens (e.g. a recall), be prepared for FDA to inspect; having your investigation report and CAPA plan ready will demonstrate control.
Catch issues before FDA does. Document them. Fix them. And learn from them. Silence is not safety—transparency is.
SHOW HOUSEKEEPING: A clean floor isn’t cosmetic—it’s compliance. Disorganized areas raise suspicions before a word is spoken. FDA eyes don’t miss clutter.
STAY INFORMED: FDA’s expectations. Guidance documents, warning letter trends, and industry communication from FDA can signal areas of emphasis.
Be the company that evolves with the agency—not one that reacts to it.
EMBRANCE TRANSPARENCY: The best defense is a good offense. Own your risks. Show your CAPAs. Invite scrutiny. Confidence comes from control, not concealment.
FDA inspect DECISIONS, VALUES & PEOPLE.
Inspections can be moments of pride. A chance to say: HERE’s HOW WE PROTECT PATIENTS, CONSUMERS & PUBLIC HEALTH—EVERY SINGLE DAY.
Prepare boldly. And when the FDA arrives, MEET THEM WITH PRIDE.
Need Help Navigating FDA Compliance? You can contact me for further information—let’s discuss how to keep your operations ahead of the curve.
Let’s make sure your facility is always inspection ready.
Read also: Anatomy of an FDA Inspection | Part 1 of 2
Resource Person: Bharathi Kodali