If you’ve been through an FDA inspection recently — or have one coming up — you may already know the name Arsen Karapetyan. As one of the FDA’s senior investigators, he has built a reputation for conducting highly detailed audits, with a sharp focus on sterile manufacturing practices and data integrity.
Understanding his inspection style and the types of deficiencies he most often cites can give your team a much-needed advantage. By learning from his recent findings, you can identify weaknesses in your own processes and address them before the FDA ever steps through your doors.
This article breaks down who Karapetyan is, the trends seen in his inspections, and actionable steps your team can take to prepare.
Who is Arsen Karapetyan?
Arsen Karapetyan is a highly experienced FDA investigator with over a decade of auditing pharmaceutical, biologics, and biotech manufacturing facilities, particularly those producing sterile products or using aseptic processes. He is known in the industry for his methodical style, high expectations for data governance, and keen eye for operational inconsistencies between documented procedures and what’s actually happening on the floor.
His audits often emphasize three core areas:
- Data integrity, especially in electronic records and batch documentation
- Environmental monitoring and control in cleanroom environments
- CAPA effectiveness, particularly whether preventive actions truly address root causes
Over the past two years alone, Karapetyan has led dozens of inspections at facilities across the United States and internationally, including India and Canada. Many of his findings highlight systemic documentation issues, training gaps, and lapses in sterile control, deficiencies that can have significant regulatory consequences if not corrected.
If you work in sterile manufacturing or handle high-risk products like biologics or injectables, it’s worth paying close attention to the kinds of issues he tends to uncover.
Top Findings From His Recent Audits
So what exactly does Karapetyan look for? Based on an analysis of 483s and warning letters issued following his inspections in 2023 and early 2024, here are the most frequent observations:
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Weak Environmental Monitoring Programs
In his observations, facilities were cited for failing to maintain adequate controls over cleanroom environments. Common issues included:
- Insufficient frequency of sampling in aseptic filling areas
- Failure to investigate environmental excursions
- Inadequate trending of microbial and particulate data
- Outdated or poorly justified cleanroom classifications
For example, during a 2023 inspection of a sterile manufacturing plant, Karapetyan cited the company for failing to adequately validate its HVAC system. This lapse allowed recurring environmental excursions to persist without investigation — a serious risk in an aseptic setting.
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CAPA Deficiencies
Another frequent theme is inadequate corrective and preventive action systems. In many facilities, Karapetyan found that CAPAs were either superficially investigated, poorly documented, or insufficient to prevent the recurrence of deviations. He often questions:
- Whether the root cause analysis was thorough
- Whether effectiveness checks were documented
- Whether corrective actions addressed systemic issues or just symptoms
This is a major red flag to FDA investigators and a recurring finding in his reports.
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Data Integrity Lapses
Data integrity issues remain a perennial problem in regulated industries, and Karapetyan consistently calls them out. Examples include:
- Missing or incomplete audit trails in electronic systems
- Delayed or backdated entries in batch records
- User access controls are too loose, allowing unauthorized changes
- Annual rather than routine audit trail reviews
During one inspection in early 2024, he flagged a sterile injectable plant because audit trail reviews were performed only once a year, leaving months-long windows where data integrity risks went unchecked.
For example, in one 2023 inspection, Karapetyan cited a facility for failing to adequately validate its cleanroom HVAC system, which led to multiple environmental excursions going unaddressed. In another, he flagged significant data integrity concerns because audit trail reviews were performed only annually, not routinely.
What Sets His Inspections Apart?
While all FDA investigators follow the same regulations and compliance guides, Karapetyan’s inspections stand out for their depth and rigor. He’s known for being:
- Meticulous about electronic systems, often drilling down into raw data rather than accepting summaries
- Unafraid to cross-reference SOPs with actual practice, walking the floor to verify what employees are really doing
- Focused on long-term systemic quality, not just point-in-time fixes
If your facility is scheduled for inspection, and Karapetyan is named as the lead investigator, assume he will expect more than just clean paperwork. He’s looking for evidence of a culture of accountability and quality, not just check-the-box compliance.
Lessons for QA and Compliance Teams
If your facility operates in sterile manufacturing or handles high-risk products, it pays to prepare as if Karapetyan himself were walking through your doors. Here’s what you can do now:
i) Strengthen Environmental Monitoring
- Review your SOPs for completeness, clarity, and alignment with current risk levels.
- Ensure that monitoring frequency, locations, and limits are justified and defensible.
- Document investigations into even minor excursions — and close them promptly.
- Reassess HVAC and cleanroom classifications to ensure they reflect actual conditions.
ii) Audit Electronic Records Systems
- Ensure audit trails are enabled, complete, and reviewed routinely.
- Review user access controls to prevent unauthorized changes.
- Validate all electronic systems and maintain validation documentation.
- Train staff on ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, + Complete, Consistent, Enduring, Available).
iii) Revisit Your CAPA Process
- Make root cause analysis a disciplined, documented step.
- Don’t close CAPAs without verifying their effectiveness.
- Analyze trends to identify systemic issues rather than treating deviations as isolated incidents.
iv) Observe Operators on the Floor
- Conduct “Gemba walks” to see whether aseptic technique and gowning practices actually match written procedures.
- Interview employees during internal audits to gauge their understanding of SOPs.
These steps aren’t just preparation for one inspector; they’re foundational to avoiding serious citations from any FDA investigator.
Using Inspector Trends to Stay Ahead
Here’s where many organizations miss an opportunity. Every inspector has patterns — focus areas, citation frequencies, even stylistic tendencies. With Atlas Compliance, you don’t have to guess.
Our platform aggregates real-time data from FDA 483s, warning letters, EIRs, and import alerts. You can see what Karapetyan and other inspectors are flagging at similar facilities, benchmark your performance against industry peers, and even predict the types of observations you’re most at risk for.
Instead of reacting to findings after the fact, you can use inspector profiles to craft proactive, site-specific CAPAs and training programs that keep you ahead of the curve.
Conclusion
At the end of the day, Karapetyan’s audits underscore a larger point: FDA inspections are evolving, but preparation remains the key. Teams that take the time to understand individual inspector trends, strengthen their weak spots, and embrace real-time regulatory intelligence consistently fare better than those who scramble when the notice comes.
If you’re serious about staying ahead of FDA expectations, tools like Atlas Compliance help turn inspection data into a strategic advantage, making every inspection a chance to prove your culture of quality, rather than a crisis to manage.
