Manufacturing Transparency: How to Access FDA Inspection Records

When you buy a pill, an inhaler, or a vaccine, you expect it to be safe. But how do you know the factory that made it followed the rules? The answer lies in manufacturing transparency-and specifically, in access to FDA inspection records. This isn’t just bureaucracy. It’s the invisible line between a medicine that works and one that could harm you.

What the FDA Can and Can’t See

The U.S. Food and Drug Administration doesn’t just show up at a factory and ask for a tour. They have legal power under Section 704(a)(1) of the Federal Food, Drug, and Cosmetic Act to walk into any facility making drugs or medical devices and demand records. But here’s the twist: not everything is open for inspection.

Under Compliance Policy Guide Sec. 130.300, the FDA generally avoids reviewing internal quality assurance audits. These are the reports a company writes to check itself-like an internal health check. The idea is simple: if companies fear those reports will be used against them, they won’t be honest. And if they’re not honest, problems stay hidden.

But here’s what the FDA can demand:

• Production records from every batch made
• Validation protocols for equipment and processes
• Deviation reports when something went wrong
• Investigations into product complaints or failures
• CAPA (Corrective and Preventive Action) plans

These aren’t optional. They’re required by 21 CFR 211.192 for drugs and 21 CFR 820.192 for devices. If a company can’t produce them during an inspection, they’re in violation-even if the final product tested fine.

Inspection Types: Routine vs. For-Cause

Not all FDA inspections are the same. In 2024, about 75% of pharmaceutical inspections were routine surveillance checks. These are scheduled, planned, and follow standard protocols. During these, the FDA sticks to the rules: no internal audit reports, just the hard records of what actually happened on the floor.

Then there’s the other 18%: for-cause inspections. These happen when something goes wrong-a contamination, a patient injury, a whistleblower tip, or a pattern of failures. In these cases, the FDA can demand everything. That includes the internal audit reports they usually avoid. Why? Because if a company is hiding systemic issues, they’re not just cutting corners-they’re putting lives at risk.

The difference matters. One type encourages honesty. The other uncovers deception.

What Happens When They Find Something Wrong?

If inspectors spot a problem, they don’t shut the plant down on the spot. They hand over Form FDA 483: a list of observations. This isn’t a fine. It’s a notice: “We saw this. Explain it.”

Companies have exactly 15 business days to respond. Not 16. Not 20. Fifteen. And the response better be detailed. The FDA doesn’t want a generic “we’re fixing it.” They want root cause analysis: Why did this happen? How did it slip through? What steps are you taking so it never happens again?

Data shows companies that follow the FDA’s recommended root cause method close 89% of their 483s within six months. Those who rush it? Only 62% succeed. The difference isn’t just paperwork-it’s whether the company truly understands the problem.

And if they don’t respond? Or if the response is weak? The FDA can issue a warning letter. Or block imports. Or even shut down production. In Q1 2025, warning letters for failing to allow inspection access jumped 17% compared to the same period last year.

Foreign Factories Are Under More Scrutiny

Over half of the world’s active pharmaceutical ingredients come from outside the U.S. That’s why the FDA has been ramping up inspections overseas.

In 2023, only 12% of foreign facility inspections were unannounced. By the end of 2025, that number will hit 35%. Domestic facilities? Still mostly scheduled-92% of the time. But foreign plants? They’re getting surprise visits more often.

Why? Because past inspections found higher rates of non-compliance. A 2024 GAO report flagged gaps in oversight of overseas manufacturers. The FDA’s response? More surprise checks. More pressure. More transparency.

Companies with foreign suppliers now spend an average of $385,000 a year just preparing for inspections. That’s not just training-it’s hiring specialists, upgrading software, and building teams dedicated to staying compliant.

Remote Inspections Are Changing the Game

In July 2025, the FDA finalized new rules for Remote Regulatory Assessments (RRAs). This means inspectors can now request digital access to records, review databases remotely, or even conduct live video walkthroughs-without ever stepping foot in the facility.

RRAs aren’t replacements for physical inspections. They’re supplements. But they’re growing fast. In the first half of 2025, 8% of all inspections were done remotely. That might sound low, but it’s up from nearly zero two years ago.

Companies that adopted RRA-ready systems cut inspection-related downtime by 65%. That’s huge. No more halting production for weeks while waiting for inspectors. No more scrambling to print thousands of pages.

Forty percent of Fortune 500 pharmaceutical companies had RRA systems in place by Q1 2025. If you’re not ready, you’re falling behind.

The Real Cost of Being Unprepared

Manufacturing transparency isn’t free. It costs time, money, and effort.

- New quality staff take 6 to 9 months to get up to speed. Certification through RAPS (Regulatory Affairs Professionals Society) boosts readiness by 37%.

- Distinguishing between protected internal audits and required investigation records takes 200-300 hours of documentation work per facility.

- 41% of quality managers report inconsistent interpretations between FDA district offices. One inspector says “this is protected,” another says “no, give it to us.” That confusion creates risk.

- 22% of warning letters in 2024 cited “non-contemporaneous records”-meaning data was backfilled or written after the fact. The FDA requires real-time logging. No exceptions.

And here’s the kicker: 78% of pharmaceutical manufacturers now have dedicated inspection readiness teams. That’s not a luxury. It’s survival.

The Big Debate: Safe Space or Blind Spot?

There’s a fierce debate in the industry.

Dr. Jane Axelrad, former FDA deputy director, says protecting internal audits creates a “safe space” for companies to find and fix problems before they become public. She points to a 1968 court case that ruled even a minor CGMP violation makes a drug “adulterated”-regardless of whether it actually harmed anyone. That means honesty is the only way to avoid legal disaster.

But Professor Daniel Troy, former FDA chief counsel, argues this policy creates “regulatory blind spots.” If a company’s internal audit says “our cleaning process is flawed,” but the FDA can’t see it, how do we know they fixed it?

The FDA’s own 2024 Compliance Program Manual walks the line: “Internal audits are critical to quality culture,” it says. “But records of product failures and deviations? Always open.”

The truth? The system works best when companies use protected audits to fix problems-and then prove it with transparent, accessible records.

What’s Next?

The FDA’s 2025-2027 Strategic Plan aims to cut inspection cycle times by 25% using digital systems. Congress is pushing for public disclosure of inspection findings through the Pharmaceutical Supply Chain Transparency Act. The industry, led by PhRMA, is fighting back, saying public records will scare companies out of honest self-audits.

But here’s the reality: patients don’t care about internal audits. They care about whether their medicine is safe. And the FDA’s job is to protect them.

The future of manufacturing transparency isn’t about hiding. It’s about proving. Proving you didn’t cut corners. Proving you caught your own mistakes. Proving you’re not just compliant-you’re trustworthy.

If you’re in manufacturing, your records aren’t just paperwork. They’re your reputation. And in this industry, reputation is the only thing that lasts longer than a prescription.