What FDA Facility Inspections Really Look Like
The FDA doesnât wait for problems to happen. Instead, they show up - unannounced or with a few daysâ notice - to check if your facility is actually doing what it says itâs doing. These inspections arenât about catching people off guard. Theyâre about making sure the medicine, device, or food youâre producing wonât hurt someone. Every year, the FDA inspects about 12,000 U.S. facilities and 1,000 overseas ones. Thatâs not random. Itâs calculated. High-risk sites - like those making life-saving drugs for elderly patients - get visited every 6 to 12 months. Low-risk sites, like some dietary supplement makers, might go 4 or 5 years between visits. The agency uses a risk-based system that weighs product type, past violations, and how complex the manufacturing process is.
The Four Types of FDA Inspections
Not all inspections are the same. There are four main types, each with a different purpose.
- Pre-approval inspections happen before a new drug or device gets approved. The FDA wants to see your production line, your validation records, and your training logs before they sign off. If your facility isnât ready, your product wonât get approved - no matter how good the science is.
- Routine surveillance inspections are the most common. These are scheduled every 2 to 5 years based on risk. Theyâre not surprise visits, but theyâre not cozy either. Youâre expected to be ready at all times.
- Compliance follow-up inspections come after youâve been cited for problems. The FDA returns to see if you fixed what they flagged. If you didnât, you could get a warning letter, a product recall, or even a shutdown.
- For-cause inspections are triggered by something specific: a spike in patient complaints, a whistleblower tip, or a pattern of adverse events. These can happen with zero notice. One facility in Ohio got visited two days after a customer reported a faulty insulin pump. They werenât ready. The FDA issued a warning letter within 10 days.
What Happens During an Inspection
When the FDA inspector walks in, they hand you FDA Form 482 - the official Notice of Inspection. Thatâs not a suggestion. Itâs the law. You must have a designated representative with them at all times. No hiding behind security guards or front desk staff.
The inspector will tour your facility. Theyâll watch how your staff handle materials. Theyâll open your computers. Theyâll ask for deviation reports, training records, equipment validation logs, and batch production records. They might even take samples. And theyâll ask questions - the same question, to different people. If your team gives conflicting answers, thatâs a red flag.
One common mistake? Trying to hide incomplete documentation. Inspectors know whatâs supposed to be there. If your change control log is missing entries from last quarter, theyâll find it. And theyâll write it down - on FDA Form 483.
FDA Form 483: What It Means and What to Do
FDA Form 483 lists the problems the inspector found. Itâs not a fine. Itâs not a shutdown order. But itâs serious. Itâs your official notice: âYouâre not in compliance.â You have 15 working days to respond with a corrective action plan.
Most Form 483s come down to four things:
- 78% of observations are tied to documentation gaps
- 32% are because deviation investigations were incomplete
- 24% are missing training records
- 15% are poor validation documentation
- 7% are broken change control systems
And hereâs the kicker: 45% of all observations now relate to data integrity. That means electronic records that were altered, deleted, or not properly backed up. The FDA is watching your computer systems harder than ever. If youâre still using paper logs or shared drives without access controls, youâre at risk.
How to Get Ready - And Stay Ready
You donât wait until the inspection letter arrives to prepare. You prepare every day.
Facilities with formal inspection readiness programs reduce observations by 63%. How? They do three things:
- Run mock inspections every quarter. Bring in an outside auditor. Let them ask hard questions. Donât let your team practice their answers - make them think on their feet.
- Designate one inspection coordinator. Not three. Not five. One person who knows where every document is, whoâs trained on what, and who can pull records in under 5 minutes. Companies that do this report inspections go 22% faster.
- Keep your facility diagram updated. If you moved a machine last month and didnât update the floor plan, inspectors will notice. And theyâll wonder what else youâre hiding.
Also, create a dedicated inspection room. Not a closet. A real room with printers, computers, phones, and a secure document server. During a 2023 inspection at a Michigan-based device maker, the team had documents ready in 90 seconds because theyâd built this space. The inspector later said it was the most organized facility heâd seen in six months.
The Hidden Rules No One Talks About
There are unwritten rules that make or break inspections.
First: Never guess. If you donât know the answer, say so. Then find out. Lying or making up answers is the fastest way to get a warning letter.
Second: Donât over-explain. Answer the question. Donât give a lecture. Inspectors are trained to listen for gaps. The more you talk, the more chances you have to slip up.
Third: Keep records for at least two years after a product is discontinued. In 2023, 87% of Form 483s cited expired records. Thatâs not a technical failure. Itâs a paperwork failure.
And fourth: All staff who interact with inspectors need 8 hours of training a year. Principal investigators need 16. Only 63% of clinical sites meet that. If your team hasnât been trained this year, youâre already behind.
Whatâs Changing in 2025 and Beyond
The FDA isnât slowing down. Theyâre speeding up - and going digital.
By late 2025, theyâll start using AI to review documents before inspectors even step foot in your facility. Pilot programs are already testing this with 12 sites. The AI looks for missing signatures, inconsistent dates, and data anomalies in electronic records. If it flags something, the inspector will ask for it - and you better have it ready.
Remote inspections are also growing. In 2023, the FDA did virtual tours and document reviews at 147 facilities. For 78% of documentation checks, they found the same issues as in-person visits. That means your digital records better be flawless.
Inspection frequency is shifting too. High-risk facilities - especially those making products for aging populations - will see inspections increase by 18% through 2026. Low-risk dietary supplement makers? That number is dropping. The FDA is focusing resources where the risk is highest.
In 2023, the FDA issued 1,842 warning letters. Medical device makers got 42% of them. Pharma got 38%. Thatâs not a coincidence. Itâs a signal.
Bottom Line: Quality Isnât an Event - Itâs a Habit
FDA inspections arenât about passing a test. Theyâre about proving youâve built quality into your daily operations. If youâre waiting for an inspection to clean up your records, youâre already too late.
The best facilities donât panic when the inspector arrives. They nod, hand over the documents, and say, âWeâve been expecting you.â Because theyâve been ready - every day.
Erik van Hees
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