FDA inspections are a critical hurdle for pharmaceutical manufacturers, and understanding inspector-specific risk areas can significantly enhance compliance readiness. Arsen Karapetyan, FDA, a Consumer Safety Officer based in Long Beach, CA, has conducted 196 inspections since 2009, issuing 125 Form 483s and 17 warning letters.
His reports highlight key compliance risks, particularly in investigation records and quality control procedures. This blog explores Arsen Karapetyan’s FDA inspection history and what his reports reveal about risk areas, offering actionable insights for manufacturers using tools like Atlas Compliance.
What FDA Inspections Entail?
FDA inspections are crucial for ensuring pharmaceutical manufacturers meet strict regulations. These regulations include Good Manufacturing Practices (GMP) and other standards in the Code of Federal Regulations (CFR). The goal is to maintain the safety, efficacy, and quality of pharmaceutical products.
FDA inspectors focus on several key areas during inspections:
- Documentation and Recordkeeping: Inspectors ensure proper documentation of manufacturing processes, quality controls, and testing procedures. Records must be accurate, traceable, and accessible.
- Quality Control and Assurance Procedures: Inspectors check if manufacturers have effective quality control (QC) and quality assurance (QA) systems. These systems must monitor product quality from raw materials to final release.
- Equipment Design and Maintenance: Equipment must meet strict standards. Inspectors verify that it is properly maintained, cleaned, and calibrated to prevent contamination and ensure consistency.
- Laboratory Controls and Testing: Inspectors assess if testing and laboratory controls are in place. These tests verify the identity, strength, quality, and purity of products.
- Process Validation and Monitoring: Inspectors review process validation to ensure products consistently meet specifications. Continuous monitoring of production is essential.
- Corrective and Preventive Actions (CAPA): Inspectors evaluate the CAPA system. It is designed to identify, investigate, and address nonconformities in manufacturing processes.
By addressing these areas, manufacturers can mitigate compliance risks. Arsen Karapetyan’s inspection data provides a roadmap for identifying and addressing these critical risk areas.
Who Is Arsen Karapetyan?
Arsen Karapetyan is a Consumer Safety Officer based in Long Beach, CA (90831). He can be reached at Arsen.Karapetyan@fda.hhs.gov or by phone at (562-256-9276). Since 2009, Arsen has been actively conducting inspections in over 21 countries, including the United States, China, India, Japan, and Germany. His extensive experience spans across multiple global markets, which gives him a unique perspective on pharmaceutical compliance.
Arsen’s international reach and focus on regulatory standards make his work highly relevant to professionals in the pharmaceutical industry. This includes manufacturers, quality assurance teams, and regulatory affairs experts. His findings provide invaluable insights into maintaining compliance with industry standards, making them especially useful for organizations like Atlas Compliance. With his wealth of experience and global expertise, Arsen plays a key role in shaping pharmaceutical safety practices worldwide.
Arsen Karapetyan’s Inspection History
Karapetyan’s inspection record is robust, with the following key metrics as of May 2025:
- Total Inspections: 196
- Total 483s Issued: 125
- Total Warning Letters Issued: 17
- Average Inspection Duration: 5.37 days
- Inspection Duration Range: 1–71 days
- Inspections Last Year (2024): 11
- Inspections This Year (2025): 3
Karapetyan’s high 483 issuance rate (125 out of 196 inspections) and 17 warning letters indicate a rigorous approach, with a longer average inspection duration (5.37 days) suggesting thorough evaluations. His recent activity, with 11 inspections in 2024 and 3 in 2025, underscores his ongoing relevance.
Key Compliance Issues in Karapetyan’s 483s
Karapetyan’s Form 483s highlight critical risk areas, with the top five citations focusing on:
- 21 CFR 211.192: Lack of written records for investigations, undermining traceability and corrective actions.
- 21 CFR 211.22(d): Quality control procedures not documented or fully followed, compromising product safety.
- 21 CFR 211.63: Inadequate equipment design, size, or location, posing risks to manufacturing processes.
- 21 CFR 211.160(b): Lack of scientifically sound laboratory controls, affecting product quality assurance.
- 21 CFR 211.110(a): Inadequate control procedures to monitor and validate manufacturing performance, leading to potential inconsistencies.
These citations emphasize Karapetyan’s focus on documentation, quality control, and process validation, critical areas for pharmaceutical manufacturers to address to avoid regulatory violations.
Recent Trends in Karapetyan’s Inspections
Arsen Karapetyan has conducted 11 inspections in 2024 and 3 in 2025, showcasing his ongoing focus on pharmaceutical manufacturing processes. His inspections have resulted in citations, particularly regarding investigation records (21 CFR 211.192) and quality control procedures (21 CFR 211.22(d)). These citations reflect the FDA’s strong emphasis on maintaining thorough documentation and strict process oversight.
Karapetyan’s inspections span across 21 countries, including key emerging markets like India and China. This global reach underscores the importance of aligning with international compliance standards.
For multinational manufacturers, this broad perspective is invaluable, as it helps them navigate the complexities of diverse regulatory environments. Karapetyan’s findings provide critical insights for companies aiming to maintain compliance across various regions, ensuring their operations meet global standards.
Risk Areas Highlighted by Karapetyan’s Reports
Karapetyan’s reports reveal several high-risk areas for pharmaceutical manufacturers:
- Investigation Documentation: The frequent citation of 21 CFR 211.192 indicates that incomplete or missing investigation records are a major compliance gap, increasing the risk of regulatory action.
- Quality Control Weaknesses: Non-compliance with 21 CFR 211.22(d) suggests that undocumented or poorly followed quality procedures can lead to product quality issues.
- Equipment and Process Deficiencies: Citations like 21 CFR 211.63 and 211.110(a) point to risks from improperly designed equipment and inadequate process validation, which can disrupt manufacturing consistency.
How to Mitigate Risks Using Karapetyan’s Data
To leverage Arsen Karapetyan’s inspection data for risk mitigation, manufacturers can follow these steps:
- Strengthen Documentation Practices: Review Karapetyan’s 483s to ensure thorough investigation records and documented quality procedures, addressing 21 CFR 211.192 and 211.22(d) violations.
- Enhance Equipment and Process Controls: Conduct audits to verify equipment design and process validation, aligning with 21 CFR 211.63 and 211.110(a) requirements.
- Utilize Atlas Compliance’s Platform: Atlas Compliance’s AI-powered tools, including natural language processing and predictive analytics, provide real-time access to Karapetyan’s inspection data, enabling proactive risk management.
Conclusion
Arsen Karapetyan’s 196 FDA inspections, 125 Form 483s, and 17 warning letters offer critical insights into pharmaceutical compliance risks, particularly in documentation, quality control, and process validation. His reports serve as a guide for manufacturers aiming to stay inspection-ready.
Atlas Compliance’s platform enables companies to access Karapetyan’s data, track risk trends, and strengthen regulatory strategies. Visit Atlas Compliance to learn how their tools can help your organization navigate FDA regulations and mitigate compliance risks effectively.
