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Who Is Arsen Karapetyan? A Look at His FDA Investigation Track Record

Every FDA inspector leaves a fingerprint. Patterns in the questions they ask. Trends in the violations they cite. Over time, those patterns tell you more about how to pass an inspection than the CFR handbook ever could.

Arsen Karapetyan’s fingerprint is unmistakable. With nearly 200 inspections conducted around the world and dozens of warning letters issued under his name, he has built a reputation that regulatory and quality teams pay close attention to, and, at times, quietly worry about. The findings from Arsen Karapetyan FDA inspections show up in industry forums, internal QA briefings, and pre-inspection war rooms.

If you want to better understand how the FDA thinks and what it takes to stay ahead of its scrutiny, his track record offers a roadmap. Let’s break it down.

Who is Arsen Karapetyan?

Arsen Karapetyan is a Senior Consumer Safety Officer with the FDA, based in Long Beach, California. Since 2009, he has inspected pharmaceutical and biotech manufacturing operations across the United States and internationally, earning a reputation for meticulous attention to detail and a sharp eye for systemic weaknesses.

Karapetyan’s career reflects not only longevity but also breadth: he’s inspected a wide range of facilities, from sterile injectables plants to oral solid dose manufacturers to biologics producers. His work cuts across cultural and geographic boundaries, giving him a uniquely global perspective on compliance.

At a glance:

  • Inspections conducted: ~196
  • Form 483s issued: ~125
  • Warning letters issued: ~17
  • Countries inspected: 20+
  • Recent activity: Still actively inspecting, with 3 inspections logged in 2025 alone

Karapetyan’s consistency, combined with his global reach, makes his inspection findings one of the more reliable benchmarks for understanding where FDA enforcement energy is being directed.

What His Inspection Record Reveals

Analyzing his track record surfaces unmistakable trends. The same weaknesses appear repeatedly in his inspection findings, a warning signal for any company that hasn’t tightened up these areas.

Most-Cited Violations:

Here are the top sections of 21 CFR Part 211 that Arsen Karapetyan FDA inspections, most often cite:

  • 211.192 – Inadequate investigations into discrepancies and failures

Too often, firms stop at superficial explanations for batch deviations or OOS results without conducting full root cause analyses. Karapetyan consistently flags this as a sign of poor control.

  • 211.22(d) – Failure of the quality control unit to exercise proper oversight

 If the QC unit isn’t properly staffed, lacks authority, or fails to review and approve critical documentation, expect to hear about it during one of his inspections.

  • 211.63 – Improperly designed or maintained equipment

Unqualified, poorly calibrated, or badly maintained equipment is a recurring issue, particularly in sterile operations where minor lapses can have serious consequences.

  • 211.160(b) – Insufficient laboratory controls and documentation

Incomplete, inaccurate, or undocumented lab tests undermine the validity of batch releases and draw sharp criticism.

  • 211.110(a) – Lack of adequate in-process monitoring of drug production

Without ongoing process checks and trend analysis, companies risk drifting out of control without noticing, a failure Karapetyan often identifies.

These citations tell a clear story: too many companies focus on maintaining documentation instead of maintaining control.

Why His Track Record Should Matter to You

Here’s the thing: FDA inspections aren’t random audits of paperwork. They’re active probes into whether your company’s culture, systems, and staff are truly aligned with GMP principles.

Inspectors like Karapetyan, with hundreds of site visits under their belt, develop an instinct for spotting weak points, especially the ones companies think they’ve “taken care of.”

For life sciences companies, particularly those selling into the U.S. market, understanding his patterns offers three major benefits:

  • Spot vulnerabilities early: His most-cited findings highlight systemic risks that many companies underestimate.
  • Prepare your staff: Knowing the kinds of follow-up questions he’s likely to ask makes mock inspections more realistic and useful.
  • Benchmark against your peers: His findings abroad give a view of global trends, helping multinational firms harmonize their compliance.

Because Karapetyan conducts inspections worldwide, his reports have ripple effects across industries and geographies, influencing how companies everywhere approach compliance.

How to Prepare: Turn His Patterns Into Action

So, what do you do with this insight? Focus on the weaknesses that come up most often in his reports and build stronger internal controls around them.

Here’s where to start:

  1. Audit your discrepancy investigations: Are you fully documenting root cause analysis and corrective actions?
  2. Review your quality unit: Does it have clear authority and access to all necessary data?
  3. Evaluate equipment design & maintenance logs: Are you meeting qualification and calibration standards?
  4. Check lab controls: Are tests validated and results properly recorded?
  5. Monitor in-process controls: Are process parameters actively tracked and trended?

The smartest companies build these checks into regular internal audits so they’re ahead of the curve, not scrambling to catch up after a 483.

How Atlas Compliance Can Help

For many companies, staying ahead of experienced inspectors like Karapetyan feels like guesswork. Platforms like Atlas Compliance give you the tools to proactively manage risk:

  • Centralized data: Access inspection records, 483s, and warning letters — including those issued by Karapetyan himself.
  • Trend analysis: See which CFRs are trending in citations and benchmark against your peers.
  • AI-driven risk scoring: Understand which areas of your operations are most exposed.
  • Inspector profiling: Prepare for inspections with insights into individual investigator priorities and patterns.
  • Copilot support: Draft CAPAs, summarize findings, and get guidance on next steps.

By using regulatory intelligence tools, you can turn inspector patterns into proactive action plans and stop treating inspections as surprises.

Final Thoughts

Arsen Karapetyan is just one of many experienced FDA inspectors whose work quietly shapes the compliance landscape. But his inspection history tells a clear and valuable story: too many companies are still struggling with the fundamentals, and the FDA is paying close attention.

Instead of seeing his name on an inspection notice as a reason to worry, treat it as a wake-up call. Use his patterns to strengthen your systems, train your teams, and demonstrate that you’re not just “checking boxes,” but living the principles of GMP every day.

Inspections aren’t pass/fail events — they’re opportunities to validate the strength of your quality culture. And preparation, guided by real-world inspector trends, is what separates companies that succeed from those that scramble.

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