Manufacturing Transparency: How to Access FDA Inspection Records
Jan, 7 2026
When you buy a pill, an inhaler, or a medical device, you assume it’s safe. But how do you know? The answer lies in manufacturing transparency - specifically, in what the FDA can see inside a factory that makes your medicine.
What the FDA Can and Can’t See
The U.S. Food and Drug Administration doesn’t just show up at factories for surprise tours. They have legal authority under Section 704(a)(1) of the Federal Food, Drug, and Cosmetic Act to inspect any facility making drugs, medical devices, or biologics. But that doesn’t mean they get access to everything. Here’s the key distinction: CGMP records - like production logs, batch records, validation reports, and deviation investigations - are fully open to inspection. These are the raw, real-time documents that prove a company followed quality rules while making the product. But internal quality audits? Those are different. Under FDA’s Compliance Policy Guide (CPG) Sec. 130.300, the agency generally does not review internal audit reports if they’re part of a company’s own quality system. Why? Because the FDA wants companies to be honest with themselves. If every slip-up in an internal audit could be used against them, companies might stop doing those audits altogether. That’s not better safety - it’s hidden risk. So if a company finds a problem in its own audit, they can fix it quietly. But if that same problem shows up in a batch record or a customer complaint, the FDA will see it - and they’ll want answers.What Records Must Be Kept - And For How Long
It’s not enough to just make the product right. You have to prove you did. That’s why the FDA requires detailed recordkeeping. For pharmaceuticals, 21 CFR 211.180 says you must keep CGMP records for at least one year after the product’s expiration date. For medical devices, it’s even longer: 21 CFR 820.180 requires records to be kept for the life of the device plus two years. That means a pacemaker made in 2020 could still have its manufacturing records under review in 2040. These records aren’t just files in a drawer. They must be contemporaneous - written at the time the work was done. No backdating. No guessing. In 2024, 22% of FDA warning letters cited this exact failure: records created after the fact, or missing altogether. Inspection teams look for:- Batch production and control records
- Validation protocols for equipment and processes
- Deviation reports - what went wrong, and how it was fixed
- CAPA (Corrective and Preventive Action) documentation
- Complaint files and investigation logs
Form FDA 483: The Warning That Changes Everything
If an FDA inspector finds something wrong, they don’t shut you down on the spot. They hand you Form FDA 483 - the Notice of Inspectional Observations. This isn’t a fine. It’s a list. Maybe five items. Maybe twenty. Each one says: “We saw this. You didn’t follow the rules.” You have exactly 15 business days to respond. No extensions. No excuses. And your response matters more than you think. Companies that use the FDA’s recommended root cause analysis method - digging deep to find the real reason something failed, not just fixing the symptom - close 89% of their 483s within six months. Those who just patch things up? Only 62% get cleared. And if you ignore it? The FDA can issue a Warning Letter. That’s public. That’s damaging. And if you still don’t fix it? Your product can be seized. Your facility can be barred from importing. Your CEO can be personally liable.
Unannounced Inspections Are Now the Norm - Especially Overseas
In 2023, only 12% of foreign manufacturing inspections were unannounced. By the end of 2025, that number will jump to 35%. Why? Because the Government Accountability Office found foreign facilities were more likely to clean up before an inspection - and hide problems during it. The FDA’s response? Show up without warning. Domestic facilities still mostly get scheduled visits - about 92% of them. But foreign plants? They’re being treated like high-risk targets. And it’s working. In 2024, foreign facilities had a 14% higher rate of critical 483 observations than U.S.-based ones. This isn’t just about geography. It’s about trust. The FDA knows a lot of the world’s medicine comes from overseas. They’re changing how they check it.Remote Regulatory Assessments: The New Way to Stay Compliant
In July 2025, the FDA finalized its rules for Remote Regulatory Assessments (RRAs). These aren’t inspections. They’re virtual reviews. An RRA might involve:- Accessing your digital quality system through a secure portal
- Reviewing electronic batch records via video call
- Answering live questions about your CAPA system
Why Companies Spend Over $385,000 a Year Just to Prepare
Manufacturing transparency isn’t free. It costs money - and time. A 2025 survey of 120 facilities found companies spend an average of $385,000 annually on inspection readiness. That includes:- Hiring dedicated QA staff
- Training teams on FDA expectations
- Upgrading electronic record systems
- Running mock inspections
The Big Debate: Safe Space or Regulatory Blind Spot?
There’s a growing tension in the industry. Dr. Jane Axelrad, former FDA deputy director, says the policy protecting internal audits is “essential.” It lets companies be honest with themselves. Without it, she says, “you lose the culture of continuous improvement.” But Professor Daniel Troy, former FDA chief counsel, calls it a “regulatory blind spot.” He argues that if a company has a systemic problem - say, repeated failures in sterilization - and hides it in an internal audit report, the FDA might never know until patients get hurt. The FDA’s own 2024 Compliance Program Manual walks the line: “Internal audits remain a critical component of quality culture,” it says. “But records of product complaints and deviation investigations must always be made available.” So where’s the line? If you investigate a failed batch and write a report - that’s required. If you audit your whole QA system and find a trend - that’s protected. But if you investigate a trend and then write a report? That’s risky.What’s Next? Public Records, Pressure, and Change
Congress is pushing for more transparency. The 2024 Pharmaceutical Supply Chain Transparency Act (S. 2884) would require the FDA to publish certain inspection findings online. PhRMA, the drug industry’s main lobby, opposes it. They say it will scare companies out of doing honest internal audits. The FDA’s 2025-2027 Strategic Plan aims to cut inspection cycle times by 25% using digital records. They’re also cracking down harder on companies that delay or deny access. Warning letters for inspection obstruction rose 17% in Q1 2025. The message is clear: transparency isn’t optional. It’s the cost of doing business in medicine.What You Need to Do Today
If you work in manufacturing - whether you make pills, syringes, or IV bags - here’s your checklist:- Separate your internal audit reports from your quality control investigation records. Know which is protected and which isn’t.
- Ensure all CGMP records are contemporaneous. No backdating. No summaries. No “we did it this way” after the fact.
- Train your team on Form 483 response protocols. Use root cause analysis - not quick fixes.
- Build your RRA capability. Even if you’re not ready now, the FDA is moving fast.
- Review your record retention policy. Are you keeping device records for the lifespan plus two years? Are you holding drug records past expiration?
Can the FDA read my company’s internal quality audit reports?
Generally, no - if the audit is part of your formal internal quality assurance program and follows written procedures. The FDA’s Compliance Policy Guide (CPG) Sec. 130.300 protects these reports to encourage honest self-assessment. But if the audit investigates a specific product failure, complaint, or deviation, it becomes part of your quality control records - and those are fully accessible to the FDA.
How long do I have to keep manufacturing records after a drug expires?
For pharmaceuticals, you must retain CGMP records for at least one year after the product’s expiration date, as required by 21 CFR 211.180. For medical devices, records must be kept for the life of the device plus two years under 21 CFR 820.180. Failure to retain these records is one of the most common reasons for FDA warning letters.
What happens if I don’t respond to a Form FDA 483 within 15 days?
If you don’t respond within 15 business days, the FDA will likely issue a Warning Letter - a public document that can damage your reputation, trigger investor concerns, and lead to import alerts or product seizures. The FDA considers timely, thorough responses critical to resolving inspection findings. Delays are seen as a sign of poor quality culture.
Are remote inspections replacing physical ones?
Not fully - but they’re becoming a major tool. Remote Regulatory Assessments (RRAs), finalized in July 2025, allow the FDA to review records and conduct virtual evaluations without a physical visit. RRAs don’t generate Form 483s, but they can replace inspections in low-risk cases. In the first half of 2025, RRAs accounted for only 8% of inspections, but adoption is rising fast, especially among large pharmaceutical companies.
Why is the FDA doing more unannounced inspections of foreign facilities?
The FDA increased unannounced inspections of foreign facilities from 12% in 2023 to a target of 35% by the end of 2025 because GAO reports showed foreign sites were more likely to prepare for scheduled visits and hide quality issues. Unannounced inspections reduce the chance of “clean-up” before an audit and provide a more accurate picture of day-to-day compliance.
What’s the difference between a quality assurance audit and a quality control investigation?
A quality assurance audit is a proactive, system-wide review - like checking if your training program works or if your documentation controls are followed. These are protected under CPG Sec. 130.300. A quality control investigation is reactive - triggered by a specific product failure, complaint, or deviation. These records must be made available to the FDA. Confusing the two leads to over-disclosure or missed compliance.
Can the FDA inspect a facility without a warrant?
Yes. Under Section 704(a)(1) of the FD&C Act, the FDA has the legal right to inspect manufacturing facilities without a warrant. Refusing entry or delaying inspection is a violation of Section 301(f) and can lead to criminal penalties, product seizure, or facility shutdown. This authority applies to both domestic and foreign facilities.
How much do companies typically spend to prepare for FDA inspections?
According to a 2025 benchmarking study of 120 facilities, pharmaceutical and medical device manufacturers spend an average of $385,000 annually on inspection readiness. This includes hiring dedicated QA staff, training, software upgrades, mock inspections, and compliance consulting. Companies with mature RRA systems report lower long-term costs due to reduced downtime and fewer critical observations.
Pooja Kumari
January 8, 2026 AT 12:35Okay so I just spent 3 hours reading this and I’m emotionally drained lol. Like imagine being a QA person in India where the power goes out 3x a day and your server crashes and you have to manually write batch logs on paper because your laptop died and then the FDA shows up and you’re like ‘uhhh here’s my notebook from last Tuesday’? I’m not even mad, I’m impressed anyone survives this. Also why does the FDA care if I backdate a log when I was literally up for 36 hours straight fixing a sterilization failure? Nobody’s perfect, but we’re trying. Also can we talk about how $385k a year is basically a luxury tax on small manufacturers? I work for a startup and we’re lucky if we have one QA person who also answers the phone. This system is broken but I don’t know how to fix it. 😭
Jacob Paterson
January 8, 2026 AT 14:47Oh wow. So the FDA lets companies hide their internal audits? That’s not transparency, that’s a corporate free pass to lie to themselves. You think ‘honest self-assessment’ is noble? Nah. It’s just a cover for lazy, incompetent managers who don’t want to fix systemic problems until someone dies. And now you want to make it legal? This isn’t quality control - it’s a legal loophole for corporate malpractice. If your audit finds a pattern of failed sterilizations and you don’t tell the FDA, you’re not being ‘honest with yourself’ - you’re just being a criminal waiting for a lawsuit. Wake up.
Angela Stanton
January 9, 2026 AT 12:41Let’s break this down in CAPA terms. The CPG Sec. 130.300 exemption for internal audits is a classic example of a risk-based regulatory carve-out - but it’s being weaponized. The distinction between QA (systemic) and QC (reactive) is critical, but in practice? 80% of companies blur the lines because their QMS is a Frankenstein of Excel sheets and Word docs. RRAs are the future - but only if you’ve got a validated electronic document control system with audit trails, e-signatures, and version control. If you’re still using PDFs and paper logs, you’re not ‘prepared’ - you’re a walking 483. And FYI - the 22% of warning letters citing non-contemporaneous records? That’s not ‘human error.’ That’s willful negligence masked as ‘busy season.’
Johanna Baxter
January 11, 2026 AT 05:27