Knock, Knock, It’s the FDA

The FDA is back in full swing, and inspections—both scheduled and surprise—are becoming more frequent, more detailed, and more critical than ever. As global regulators expand the scope, frequency, and depth of inspections, companies face increasing pressure to demonstrate compliance and transparency. Expanded inspections, whether triggered by legislative updates, whistleblower complaints, or routine agency policy, require heightened preparation and strategic legal readiness.

Whether you’re in food or dietary supplements, cosmetics, medical devices, pharma, or biotech, now is the time to double down on internal audit readiness. We’ll look here how companies can prepare for expanded FDA facility inspections through structured desktop and onsite audits, with insights into best practices, common pitfalls, and a touch of humor to ease the regulatory nerves.

The FDA is Coming, and it’s Serious

The post-pandemic world has ushered in a more active, tech-savvy FDA. While virtual inspections helped maintain oversight during COVID-19, the agency is now fully re-engaging in onsite audits, backed by data analytics, global surveillance, and increasingly risk-based priorities.

The increased attention is a result of the following factors:

• Inspection backlog: A significant number of routine inspections were delayed during the pandemic.

• Risk-based oversight: Facilities with complex processes, poor compliance history, or new technologies are now under greater scrutiny.
• Regulatory modernization: The FDA is aligning inspections with evolving public health risks and emerging manufacturing methods.

In other words: if you’re regulated, you’re on the radar.

The Golden Rule of Audits: Inspect Thyself First

One of the most effective ways to prepare for an FDA inspection is to conduct your own internal audits, specifically via desktop audits and onsite audits. Think of these as your compliance dress rehearsals—as risk-reduction tools that can help you identify and fix issues before someone else does.

 

A. Desktop Audits

A desktop audit is an internal review of documentation, without physically walking the floor. It focuses on your systems, procedures, and records. The goal of a desktop audit is to identify inconsistencies or outdated procedures before inspections, ensure that documentation aligns with actual practices, and to highlight training gaps or incomplete records.

Typical areas to assess include SOPs (Standard Operating Procedures), training documentation, CAPA logs, batch records, deviation reports and internal quality reviews.

Pro tips:

• Don’t gloss over old documents: Outdated SOPs, legacy forms, and incomplete CAPAs are red flags.
• Follow FDA logic: Review with the same mindset an inspector would—objectively and critically.
• Document your audit: A well-written internal audit report shows your commitment to ongoing compliance.

It’s like Marie Kondo-ing your compliance documents. If it doesn’t spark regulatory joy—or if it sparks a 483—it has to go (or get fixed).

B. Onsite Audits: Walk the Walk (Literally)

While desktop audits help you review documentation, onsite audits are about walking through your facility and assessing how well procedures are implemented in practice. Onsite audits typically include assessing equipment calibration and maintenance, cleanroom and gowning procedures, labeling and traceability, environmental monitoring, inventory and material storage, and personnel behavior and training implementation.

We recommend developing and/or updating an audit checklist based on FDA regulations and guidance documents, interviewing staff to confirm that employees understand their roles and can explain their process clearly and confidently, and looking for real-time documentation (e.g. if something was cleaned or calibrated, it should be recorded immediately and accurately).

Common mistakes to avoid include staging compliance, e.g. only preparing when an inspection is imminent, having incomplete or missing logs, and having disconnected practices and procedures.

Train Your Team: Preparedness is a Group Effort

Your people are your best asset, and your biggest risk if unprepared. Accordingly, we strongly recommend preparing staff for inspections via mock interviews, assigning clear roles, and having inspection communication training (e.g. what to say and not to say).

Document Everything (And then document that you documented it!)

The most important rule of inspections: If it’s not written down, it didn’t happen. Auditors rely on evidence, not assumptions. Accordingly, good documentation practices include having dates, times, and initials every where and every time, timely entries and not next-day recollections, and clear audit trails for changes or corrections.

Concluding Comment: Inspect Yourself Before You Wreck Yourself

Expanded FDA inspections are the new normal and with strong internal audit systems—desktop and onsite—you can catch issues before they become headlines or inspection findings.

Companies that proactively conduct audits will be better equipped to:

• Avoid costly 483s and warning letters
• Improve operational consistency
• Demonstrate a strong compliance culture

Above all, it’s not about creating a perfect record—it’s about creating a reliable, inspectable process. With the right preparation, your next FDA inspection can be just another day at the (compliant) office!

For more information on FDA’s expanded inspection announcement, including support for conducting desktop or onsite audits at your faciltiy, or for other questions on FDA regulatory compliance or enforcement, please contact info@garg-law.com.