Are You Ready for the New Wave of FDA Auditing?

Recent changes to the FDA’s auditing process could impact how facilities prepare for an inspection. Be prepared by knowing what to expect.

As operations leaders and quality managers, we all have a general idea of how an FDA audit will go. Inspectors arrive at your site, present their badges and 482 Notice of Inspection, and sit down for a brief overview of the site while the announcement of “THE FDA IS HERE!” travels like wildfire through your company. Once the formalities are over, inspectors request a tour of the facility so that they are better grounded for their documentation review. Following a brief tour is typically a multi-day iterative process of SOP and record requests, reviews, and discussions. All taking place in the quiet setting of a front conference room and a loud, bustling back room. Well, this process that we have all grown accustomed to may never look the same again. Below I will share some insights from the recent FDA audit my company went through in Sept 2016. We are a contract manufacturer that produces cosmetic and OTC products.

Inspection Day

The FDA spent almost their entire first day touring the facility. Looking through materials in warehouse racks, behind tanks, at cleaning solution labels, at every calibration sticker they passed, and any documentation or log that was visible. This part of the audit felt reminiscent of a large customer quality assurance audit (except those are announced in advance!). KEY TAKEAWAY: Your site always needs to be in control and tour ready. Without that, you will be most vulnerable on Day 1 of the audit. First impressions set the tone, and auditors are now looking harder than ever to find physical non-compliances and get a feel for your quality systems in action. Establish the proper housekeeping and frequent internal audit program to ensure that you are ready for a detailed inspection of your facility at any time. Annual self-improvement audits are just not going to cut it.

Even after we made it to the record review phase on Day 2, the FDA returned to the manufacturing areas and labs multiple times. They wanted to observe if anSOP they just reviewed was being followed properly by the operator. They wanted to talk to the analyst performing a test method to see if they fully understood and executed the task. They asked for training records as a follow-up. Overall they spent nearly 50% of their time on the floor.


Across the industry, regulatory agencies are looking for clear, objective evidence that a system is healthy and being executed to standard. The same transformation has already begun in the food industry with FSMA. Gone are the days where a detailed SOP and flawless batch records satisfy an auditor. They want to see that these systems are alive and healthy in real time.

Innocently sounding questions were leveraged to determine if an individual truly understood their SOPs and GMPs. On occasion, an auditor even ventured an erroneous summary of a company policy or system (that didn’t meet our SOP or GMP requirements) that had to be corrected by their hosts.


Ensure you have a robust training and qualification program, and ongoing SOP & GMP refresher training. This will give your employees the skills needed to perform their tasks and meet GMP requirements, and the confidence to explain this to the FDA.

This new audit approach has brought a refinement to the audit strategy. Alternating between record review and on-the-floor auditing enables the auditors to truly connect the dots and assess the strengths of your quality systems. One example is your pest control program. Auditors spent time looking at our pest control traps, signs of damage in the facility, and dock door closures on the first day. When they reviewed our pest control records later on, they specifically looked for the defects and recommendations noted by our pest control company. Did we take action on the outages noted and was the CAPA effective?


Ensure all your externally executed systems like pest control and HVAC maintenance are healthy and defects/recommendations are being actioned in a timely manner. Utilize a CAPA effectiveness program to ensure observations that have been closed remain closed.

I am happy to report that my company finished the audit with ZERO 483’s, but I can’t say the same about gray hairs!Hopefully this guide will help you prepare for the new wave, and spare a few hairs in the process. I wish you compliance on your next regulatory audit!

Has your facility undergone a recent FDA inspection? Share your experience in the comments section below.

Lauren Wilson