How Facility Maintenance Can Trigger Regulatory Trouble

Facility issues might not always look serious at first. But in recent inspections, regulators have shown that even small signs of damage or neglect can quickly become major compliance concerns.

Things like cracked walls, stained ceilings, or peeling floor paint might seem minor to staff on-site, but inspectors often see them as signs of deeper problems.

In the era of the revised Annex 1 facility maintenance is no longer just about good housekeeping. Its not seen as a core part of contamination control.

If the physical environment doesn’t meet expectations, inspectors will assume other systems may be failing too.

Operator Oversight in Sterile Production.

What Inspectors Are Seeing

FDA inspectors continue to flag poor maintenance in cleanroom areas, and the findings are often surprisingly basic.

In one inspection, regulators found a facility with stained ceilings, peeling paint, and residue building up on cleanroom surfaces. A leaking purified water hose was left submerged in a bucket of stagnant water, raising obvious contamination risks.

In another case, inspectors noted visible grease-like residue on product-contact equipment that supposedly had been cleaned. The facility hadn’t performed proper cleaning or maintenance, and the equipment remained visibly dirty after “cleaning” was complete.

These aren’t unusual issues.

They’re common, everyday maintenance failures that happen when small problems are overlooked or allowed to build up. But to inspectors, these signs point to something bigger, an environment that may not be fully under control.

Where the Risk Really Starts

A lot of the risk lies beneath the surface, literally.

When a wall or floor coating starts to peel, or when a crack forms in a ceiling panel, those damaged areas can become hotspots for contamination. Microorganisms love to hide in hard-to-clean places. And once they’re in, they can be very difficult to remove completely.

In high-grade areas like Grade A and B zones, this is especially risky. These are the spaces where product and components are most vulnerable. So, any damage to the environment isn’t just a maintenance issue, it’s a sterility risk.

Annex 1 clearly states that facilities must be designed and maintained in a way that reduces microbial contamination. This means surfaces should be smooth, sealed, and easy to clean. It also means that signs of damage should be acted on quickly, not ignored or delayed.

Older Buildings, Higher Expectations

Many pharmaceutical facilities have been operating for years, sometimes decades. That’s not a problem in itself. But as standards rise, older buildings need to work harder to stay in compliance.

The latest Annex 1 revision encourages facilities to move toward better design features, improved airflow, and even the use of isolators and RABS. But even if a full upgrade isn’t possible yet, inspectors still expect to see an active, ongoing maintenance program.

That includes things like:

• A regular inspection schedule for all cleanroom surfaces.

  
  

• Clear criteria for when a wall or floor needs to be recoated or replaced.

  
  

• Fast responses to water damage, cracks, or other visible wear.

  
  

• Risk-based justification if materials don’t fully meet modern standards.

It’s not enough to say the issue will be fixed later. Inspectors want to see that facility risks are known, tracked, and being managed.

If You Can See It, So Can the Inspector

Facility issues are easy to overlook. A small crack or stain might not seem urgent.

But to an inspector, these signs suggest that the company may not be in full control of its GMP environment.

When facilities are allowed to age without regular upkeep, the risk of contamination grows. And so does the risk of regulatory action. Staying on top of wear and tear is more than good practice, it’s part of your contamination control strategy.

Every leak, stain, or broken tile is a signal. It tells you something about how your facility is running, and how others may view your overall quality culture.

If you can see it, the inspector will too. And they’ll likely write it up.

Don’t Let Minor Damage Lead to Major Findings

At Pharmalliance Consulting Ltd, we help pharmaceutical teams embed facility maintenance into their GMP compliance strategy, before it becomes a regulatory issue.

Learn more about GMP compliance and facility upkeep through our CPD-certified GMP Fundamentals Program: pharmalliance.ie/challenge-page/8e9165a7-c79a-4cc0-afb6-5e877ad62974.

Because worn walls and water stains don’t just look bad, they reflect your overall state of control.