Cleaning for cGMP Compliance: What Does the FDA Look for During an Inspection?

What Is an FDA Form 483 and Why Does It Matter for cGMP Compliance?

Last year, the FDA issued 380+ cleaning-related inspectional observations to life science companies operating in the pharmaceutical, device, and biologic spaces. 

Inspectional observations are known in the U.S. as Form 483s. Regulatory agencies, like the FDA, issue these types of findings to companies operating in cGMP (Current Good Manufacturing Practice) environments following an inspection. According to the FDA website, a company receives a Form 483 “when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.”

A Form 483 isn’t a “final determination” of a violation of the FD&C Act, but it is important because once issued, companies are expected to address the observations promptly to avoid: 

• warning letters 
• product holds 
• enforcement actions 

 

Inspectional observations are not always related to cleaning. However, an analysis of the FDA’s system-generated 483s reveals that in FY24, cleaning, sanitization, and equipment maintenance deficiencies accounted for roughly 8% of all Form 483s issued across the pharmaceutical, biologics, and medical device sectors. In pharmaceutical operations, one in every seven observations concerned clean equipment or sanitization gaps.

How Do cGMP Inspections Impact Life Science Facilities?

In the U.S. life science industry, cleanroom facilities can expect a regulatory inspection approximately every two years, though frequency varies based on risk profile or compliance history. In other countries, the audit schedule can vary based on risk or other factors. Clients of contract manufacturing organizations (CMOs) or contract research organizations (CROs) can request an audit at any time to ensure compliance with regulatory requirements. 

Regardless of the inspection schedule, audit readiness should not be an occasional concern—it should be a constant concept ingrained in the facility every day. Cleaning, sanitization, and equipment maintenance are central to audit readiness and product safety. That’s why the Janitronics GMP cleaning team adheres to our “audit-ready” philosophy. 

What Makes Janitronics an Ideal Partner for GMP Audit Readiness?

When your life science organization partners with Janitronics, our highly skilled GMP cleaning team will execute your existing GMP cleaning program and Standard Operating Procedures (SOPs) for non-product-contact areas of your cleanroom or lab. 

Our qualified experts will also assess and make recommendations for process improvement for your GMP Cleaning Program. 

While Janitronics is not involved in the cleaning validation process, we do offer feedback from a cleaning perspective, which is important to validate cleaning protocols. Under 21 CFR 211.67 of the Code of Federal Regulations, cleaning validation is the documented process of demonstrating that a cleaning procedure can reliably and consistently remove residue to ensure product integrity. 

Janitronics provides the expertise and consistency needed to maintain compliance with federal regulations and ensure audit readiness.

Our team joins the many internal and external stakeholders participating in the audit readiness process, and we take our role with the utmost seriousness. As Daniel Soares, Janitronics’ VP of Operations for Life Sciences Division, explains, audit readiness is more than a deliverable–it’s a shared commitment.

“Janitronics delivers the essential GMP cleaning service, a key piece of your overall audit readiness. We ensure this crucial service is flawlessly executed, so our clients can approach their audits without concern for facility cleanliness and compliance.”

What Are the Common Findings and Facility Challenges from cGMP Inspections?

To be inspection-ready and in cGMP compliance, it’s critical to understand what regulatory agencies are looking for and the challenges of controlled environments. 

Across drug, biologics, and medical device facilities, cleaning and maintenance inspectional observations ranged from missing documentation and incomplete SOPs to inadequate maintenance schedules. The top cleaning and maintenance findings are as follows:

• Drug facilities: Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product
• Device facilities: Schedules for the adjustment, cleaning, and other maintenance of equipment have not been established or are inadequate.
• Biologic facilities: Failure to maintain facilities in a clean and orderly condition.

 

While there are many reasons for these types of findings, the Janitronics Life Science team attributes many of these issues to aging cleanrooms, corrosion, and surface damage due to harsh sporicidal agents. 

Anne Marie Dixon-Heathman, a leading expert in contamination control and the Owner and President of Cleanroom Management Associates, is a long-time partner of Janitronics and highly knowledgeable in the audit process. She explains that aging cleanrooms are high on the FDA’s list right now: 

“The clean rooms are aging so quickly because of the sporicidal agents…The surfaces are abused, and that results in significant issues because if the surface is not properly sealed. Any breach will lead to significant contamination issues.”

With limited downtime for repairs, companies are deferring critical maintenance. When facilities aren’t updated, they are much more open to non-compliance.  

These common issues and facility challenges highlight why a cGMP cleaning program requires trained teams that understand these risks and are equipped to catch them ahead of time. 

What Is Janitronics’ Approach to cGMP Cleaning and Audit Readiness?

Janitronics’ skilled GMP Cleanroom Cleaning Operators often spend more time in the cleanroom than some of our customer contacts. We often serve as the facility’s eyes and ears. They are constantly identifying potential risks and helping ensure every surface meets the highest standards of cGMP compliance. 

Through internal audits, ongoing training, and strict adherence to cGMP principles, we help cleanrooms remain inspection ready. Our approach to cGMP cleaning includes: 

• Routine quality audits: Janitronics’ performs three internal audits per site per quarter and provides an in-depth overview of findings and recommendations. These audits focus on GDPs (good documentation practices), material transfer processes, solution preparation, and cleaning and sanitization protocols and techniques. 

• Checklists and performance monitoring: In conjunction with these audits, we utilize a checklist to confirm these procedures are being followed correctly and to identify process improvement opportunities.

• SOP reviews for cleaning flow and material transfer: The GMP cleaning team will review SOPs to ensure the flow of materials and cleaning aligns with cGMP compliance.

• Self-auditing program: We instituted a self-auditing program to continually improve, thereby better supporting our clients.

 

By implementing audit readiness into our processes and procedures, we can help our clients stay ahead of issues and keep operations running smoothly.  

How Does Janitronics Partner with Life Science Clients Through Corrective Actions?

Even with the most robust programs in place, 483s and inspectional observations can still happen. But, as your GMP cleaning team, the Janitronics team is right there with you when they do. The team works closely with you to identify process improvement measures whenever an audit finding is associated with a cleaning gap. 

While our client is ultimately responsible for updating SOPs, implementing recommended improvements, and cleaning validation, it’s still a collaborative process. We work with your MFG, Facilities, QA/QC (Manufacturing, Facilities, Quality Assurance and Quality Control) teams to develop a remediation plan within the required timelines. 

Connie Correia, Janitronics’ Director of Quality and Compliance, Life Science, explains Janitronics’ high-touch experience:

 “Should a client receive an FDA Form 483 or any cleaning-related observation, we immediately partner with them to determine the best practices for remediation, identifying necessary procedural changes and developing a robust action plan and ensure the final regulatory response reflects best-in-class compliance practices.”  

Why Janitronics? The Most Trusted Team in Greater Boston

As the most trusted team in Greater Boston for lab space services and cleanroom cleaning, Janitronics recognizes the enormous responsibility of servicing lab spaces. A single overlooked detail in cleaning or documentation can ripple across the organization, impacting quality systems, client confidence, and regulatory trust. Furthermore, any sort of interruption can lead to a delay in getting medicine to patients in need. 

With the right GMP cleaning partner, your life science company can have peace of mind through proactive inspection readiness. At Janitronics, audit readiness is a mindset and a philosophy—it’s embedded in everything we do for our GMP client partners. We approach each relationship with proactive collaboration, not just service delivery.

Our ultimate goal is to help clients feel confident that their facilities meet the highest standards of regulatory readiness. 

Learn more about our lab cleaning and cleanroom cleaning services and why some of the world’s most premier life science companies trust Janitronics as their partner.