Manufacturing Transparency: How to Access FDA Inspection Records

When you take a pill, inject a vaccine, or use a medical device, you expect it to be safe. But how do you know it actually is? The answer lies in manufacturing transparency-specifically, what the FDA can see inside a drug or device factory. It’s not about public dashboards or press releases. It’s about raw, unfiltered access to records that prove a company is following the rules. And if you work in manufacturing, or rely on these products, you need to understand exactly what those records are-and what the FDA can and can’t see.

What the FDA Can Inspect (And What It Can’t)

The FDA doesn’t walk into a factory and ask for everything. It knows exactly what it needs: records that prove the product was made the right way, every time. Under 21 CFR 211.180 and 21 CFR 820.180, manufacturers must keep detailed documentation on production, testing, deviations, and corrections. These include batch records, validation protocols, equipment logs, and investigation reports when something goes wrong. If a tablet breaks apart during testing, or a syringe fails sterility checks, that investigation? The FDA gets it. No exceptions.

But here’s where it gets tricky: internal quality audits. These are the reports a company writes for itself-like a self-check before an auditor shows up. The FDA’s Compliance Policy Guide (CPG) Sec. 130.300 says it generally won’t review these. Why? To encourage honesty. If companies fear their candid mistakes will become public enforcement actions, they won’t do the audits at all. That’s a policy designed to protect quality culture, not hide problems.

But don’t confuse that with protection. If a company hides a real product failure inside an audit report, the FDA can still find it-because the actual investigation records, the raw data, the lab notes? Those are always open. The policy protects the summary. It doesn’t protect the evidence.

Inspection Types: Routine vs. For-Cause

Not all FDA visits are the same. In 2024, about 75% of pharmaceutical inspections were routine surveillance checks. These are scheduled, planned, and follow a standard checklist. The FDA looks at the usual suspects: batch records, cleaning logs, training files. They won’t dig into internal audit summaries unless something raises a red flag.

Then there’s the other 18%: for-cause inspections. These happen because of a complaint, a product recall, or a pattern of failures. When the FDA shows up for a for-cause inspection, everything’s on the table. Internal audit reports, employee emails, even draft versions of SOPs. The agency has full legal authority to demand them. And they will.

Foreign facilities face even tighter scrutiny. In 2023, only 12% of inspections there were unannounced. By the end of 2025, that number will jump to 35%. Domestic plants? Still mostly scheduled. But for overseas factories-where supply chain risks are higher-the FDA is shifting to surprise visits. No warning. No prep time. Just inspectors showing up, ready to review records on the spot.

What Happens When They Find Something Wrong?

If an inspector spots a problem, they don’t just yell. They hand you Form FDA 483. This isn’t a fine. It’s a list of observations-things that don’t match the rules. Maybe a machine wasn’t calibrated. Maybe a batch record was signed off without testing. Maybe the cleaning log was backdated.

You have exactly 15 business days to respond. Not 16. Not 20. Fifteen. And your response better be detailed. The FDA expects a root cause analysis-not just “we fixed it.” They want to know why it happened, how you’re stopping it, and proof that your fix works. Companies that follow the FDA’s recommended methodology close 89% of these issues within six months. Those that give vague answers? Only 62% get resolved.

And if you ignore it? That’s when you get a warning letter. Or worse-a consent decree. One company in 2024 lost six months of production because they didn’t respond properly to a Form 483. Their product couldn’t be shipped. Revenue dropped. Reputation took a hit. All because they treated the 15-day window like a suggestion.

Remote Inspections Are Changing the Game

In July 2025, the FDA finalized its guidance on Remote Regulatory Assessments (RRAs). This isn’t a physical visit. It’s a virtual one. The agency can ask for read-only access to your digital systems. They can watch your quality software in real time. They can request specific records via secure portal. No plane ticket. No hotel. Just a Zoom call and a password.

RRAs don’t generate Form 483s. But they can trigger a full inspection. And they’re catching on fast. By Q1 2025, 73% of Fortune 500 pharmaceutical companies had built RRA-ready systems. Why? Because companies using RRAs cut inspection-related downtime by 65%. That’s six weeks of production saved per year. For a facility making millions of doses, that’s millions in revenue.

But RRAs aren’t a loophole. They’re a tool. If your records are messy, inconsistent, or incomplete, the FDA will see it. And they’ll come in person.

What Manufacturers Are Really Doing

Most companies don’t wait for the FDA to show up. They hire teams just to get ready. A 2025 study of 120 facilities found the average company spends $385,000 a year on inspection readiness. That’s not software. That’s people. Trained staff. Consultants. Audits. Simulations. Mock inspections.

One Merck QA manager told the Biophorum forum that the 15-day response window is brutal. “You’re juggling product launches, supply chain issues, and now this. It’s not just paperwork-it’s crisis management.”

And confusion is common. A survey of 47 quality professionals found that 63% over-disclosed records because they couldn’t tell what was protected and what wasn’t. They handed over internal audit reports thinking they had to. They didn’t realize those were shielded under CPG Sec. 130.300.

Another issue? Inconsistency. The FDA’s policy is clear. But how it’s applied? Not always. A 2024 survey of 215 quality executives found that 41% saw different interpretations between FDA district offices. One inspector says, “Show me the audit.” Another says, “No, that’s protected.” That kind of inconsistency forces companies to prepare for the worst-case scenario-every time.

How to Get It Right

If you’re in manufacturing, here’s what you need to do:

1. Separate your records. Create two clear buckets: Protected Internal Audits (for self-improvement) and Required Quality Investigations (for FDA). Label them. Store them separately. Train your team.
2. Document in real time. The FDA wants contemporaneous records. No backdating. No “I’ll fill this out tomorrow.” If you’re not writing it down while you’re doing it, you’re already in violation. 22% of warning letters in 2024 cited this.
3. Train your team. New hires need 6-9 months to learn the system. Certification through RAPS improves readiness by 37%. Don’t skip this.
4. Prepare for RRAs. Even if you don’t think you’ll get one, build digital systems that can share records securely. It’s not optional anymore.
5. Respond to Form 483 like your business depends on it. Because it does. Use root cause analysis. Show evidence. Don’t just say “we fixed it.” Show how you’ll never let it happen again.

What’s Next?

The FDA’s 2025-2027 plan targets a 25% reduction in inspection cycle times. That means faster, smarter, more digital reviews. Companies that cling to paper files and manual logs will fall behind.

Congress is also pushing for more transparency. The 2024 Pharmaceutical Supply Chain Transparency Act proposes making certain inspection findings public. The drug industry opposes it, arguing it will scare companies out of doing honest internal audits. But the public wants to know: Is this medicine safe?

The truth? Manufacturing transparency isn’t about giving the FDA everything. It’s about giving them what matters: proof that you’re doing your job right. The rest? That’s your internal business. But if you’re not honest in your investigations, if you’re not ready for an unannounced visit, if you’re not keeping real-time records-you’re not just risking a Form 483. You’re risking patient safety.

And in this industry, that’s the one thing no company can afford to lose.